Trial Outcomes & Findings for A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated (NCT NCT06310005)
NCT ID: NCT06310005
Last Updated: 2025-12-22
Results Overview
Number of participants with treatment-emergent adverse events (TEAE) is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
SRD part: From BI 3006337 administration until end of residual effect period (REP), 3 weeks. MD part: From first until last BI 3006337 administration + REP, up to 9 weeks.
Results posted on
2025-12-22
Participant Flow
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising subcutaneous doses and multiple subcutaneous doses over 6 weeks of BI 3006337 in healthy male Japanese subjects (single-blind, randomised within dose groups, placebo controlled, parallel group design).
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
Participant milestones
| Measure |
Placebo (SRD)
Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.
|
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose
Participants received one single 50 milligrams (mg) dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 100 mg Dose
Participants received one single 100 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 150 mg Dose
Participants received one single 150 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
Placebo (MD)
Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
Multiple Dose Part (MD): BI 3006337 150 mg Dose
Participants received one 150 mg dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
3
|
9
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated
Baseline characteristics by cohort
| Measure |
Multiple Dose Part (MD): BI 3006337 150 mg Dose
n=9 Participants
Participants received one 150 mg dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
Total
n=36 Participants
Total of all reporting groups
|
Placebo (SRD)
n=6 Participants
Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.
|
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose
n=6 Participants
Participants received one single 50 milligrams (mg) dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 100 mg Dose
n=6 Participants
Participants received one single 100 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 150 mg Dose
n=6 Participants
Participants received one single 150 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
Placebo (MD)
n=3 Participants
Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.4 Years
STANDARD_DEVIATION 8.8 • n=77 Participants
|
30.8 Years
STANDARD_DEVIATION 8.6 • n=37 Participants
|
31.7 Years
STANDARD_DEVIATION 6.7 • n=18 Participants
|
34.5 Years
STANDARD_DEVIATION 10.9 • n=102 Participants
|
28.2 Years
STANDARD_DEVIATION 9.1 • n=30 Participants
|
27.7 Years
STANDARD_DEVIATION 8.1 • n=37 Participants
|
31.3 Years
STANDARD_DEVIATION 10.1 • n=127 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=77 Participants
|
36 Participants
n=37 Participants
|
6 Participants
n=18 Participants
|
6 Participants
n=102 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=37 Participants
|
3 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=77 Participants
|
36 Participants
n=37 Participants
|
6 Participants
n=18 Participants
|
6 Participants
n=102 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=37 Participants
|
3 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=77 Participants
|
36 Participants
n=37 Participants
|
6 Participants
n=18 Participants
|
6 Participants
n=102 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=37 Participants
|
3 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=77 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
PRIMARY outcome
Timeframe: SRD part: From BI 3006337 administration until end of residual effect period (REP), 3 weeks. MD part: From first until last BI 3006337 administration + REP, up to 9 weeks.Population: Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
Number of participants with treatment-emergent adverse events (TEAE) is presented.
Outcome measures
| Measure |
Placebo (SRD)
n=6 Participants
Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.
|
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose
n=6 Participants
Participants received one single 50 milligrams (mg) dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 100 mg Dose
n=6 Participants
Participants received one single 100 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 150 mg Dose
n=6 Participants
Participants received one single 150 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
Placebo (MD)
n=3 Participants
Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
Multiple Dose Part (MD): BI 3006337 150 mg Dose
n=9 Participants
Participants received one 150 mg dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAE)
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Within 3 hours (hrs) before BI 3006337 administration and at 1.5, 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, and 672 hrs, and at end of trial examination, up to Day 40 after BI 3006337 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all participants in the TS who provided at least one pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf) is presented.
Outcome measures
| Measure |
Placebo (SRD)
n=6 Participants
Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.
|
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose
n=6 Participants
Participants received one single 50 milligrams (mg) dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 100 mg Dose
n=6 Participants
Participants received one single 100 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 150 mg Dose
Participants received one single 150 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
Placebo (MD)
Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
Multiple Dose Part (MD): BI 3006337 150 mg Dose
Participants received one 150 mg dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
|
41400 hours*nanograms/milliliters (h*ng/ml)
Geometric Coefficient of Variation 35.7
|
61400 hours*nanograms/milliliters (h*ng/ml)
Geometric Coefficient of Variation 23.1
|
109000 hours*nanograms/milliliters (h*ng/ml)
Geometric Coefficient of Variation 34.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (hrs) before BI 3006337 administration and at 1.5, 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, and 672 hrs, and at end of trial examination, up to Day 40 after BI 3006337 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all participants in the TS who provided at least one pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 3006337 in serum (Cmax) is presented.
Outcome measures
| Measure |
Placebo (SRD)
n=6 Participants
Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.
|
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose
n=6 Participants
Participants received one single 50 milligrams (mg) dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 100 mg Dose
n=6 Participants
Participants received one single 100 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 150 mg Dose
Participants received one single 150 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
Placebo (MD)
Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
Multiple Dose Part (MD): BI 3006337 150 mg Dose
Participants received one 150 mg dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 3006337 in Serum (Cmax)
|
665 nanograms/milliliters (ng/ml)
Geometric Coefficient of Variation 43.7
|
1050 nanograms/milliliters (ng/ml)
Geometric Coefficient of Variation 78.9
|
1730 nanograms/milliliters (ng/ml)
Geometric Coefficient of Variation 46.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (hrs) before last BI 3006337 administration and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, and 168 hrs after last BI 3006337 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all participants in the TS who provided at least one pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCtau, ss) after the last dose in Week 6 is presented.
Outcome measures
| Measure |
Placebo (SRD)
n=9 Participants
Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.
|
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose
Participants received one single 50 milligrams (mg) dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 100 mg Dose
Participants received one single 100 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 150 mg Dose
Participants received one single 150 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
Placebo (MD)
Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
Multiple Dose Part (MD): BI 3006337 150 mg Dose
Participants received one 150 mg dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Dosing Interval Tau at Steady State (AUCtau, ss) After the Last Dose in Week 6
|
91600 hours*nanograms/milliliters (h*ng/ml)
Geometric Coefficient of Variation 41.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (hrs) before last BI 3006337 administration and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, and 168 hrs after last BI 3006337 administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all participants in the TS who provided at least one pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 3006337 in serum at steady state (Cmax, ss) after the last dose in Week 6 is presented.
Outcome measures
| Measure |
Placebo (SRD)
n=9 Participants
Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.
|
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose
Participants received one single 50 milligrams (mg) dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 100 mg Dose
Participants received one single 100 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 150 mg Dose
Participants received one single 150 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
Placebo (MD)
Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
Multiple Dose Part (MD): BI 3006337 150 mg Dose
Participants received one 150 mg dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Cmax, ss) After the Last Dose in Week 6
|
1720 nanograms/milliliters (ng/ml)
Geometric Coefficient of Variation 76.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo (SRD)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SRD Part: BI 3006337 100 mg Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SRD Part: BI 3006337 150 mg Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (MD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multiple Dose Part (MD): BI 3006337 150 mg Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (SRD)
n=6 participants at risk
Participants received one single dose of Placebo matching BI 3006337, as subcutaneous injection on Day 1 of the single-rising dose part.
|
Single-rising Dose Part (SRD): BI 3006337 50 mg Dose
n=6 participants at risk
Participants received one single 50 milligrams (mg) dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 100 mg Dose
n=6 participants at risk
Participants received one single 100 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
SRD Part: BI 3006337 150 mg Dose
n=6 participants at risk
Participants received one single 150 mg dose of BI 3006337 as subcutaneous injection on Day 1 of the single-rising dose part.
|
Placebo (MD)
n=3 participants at risk
Participants received one dose of Placebo matching BI 3006337, as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
Multiple Dose Part (MD): BI 3006337 150 mg Dose
n=9 participants at risk
Participants received one 150 mg dose of BI 3006337 as subcutaneous injection once per week for 6 weeks (multiple dose part (MD)).
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
55.6%
5/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Malaise
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
22.2%
2/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
22.2%
2/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
22.2%
2/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Investigations
Urinary occult blood positive
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
33.3%
2/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract inflammation
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
11.1%
1/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/6 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/3 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
0.00%
0/9 • For on-treatment AEs: From BI 3006337 administration until end of residual effect period (REP), 3 weeks (SRD part). From first until last BI 3006337 administration + REP, up to 9 weeks (MD part). For all-cause mortality: From first drug administration until end of trial (EoT), up to 40 days (SRD) and up to 74 days (MD).
Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug.
|
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