Trial Outcomes & Findings for A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated (NCT NCT06429137)
NCT ID: NCT06429137
Last Updated: 2026-08-10
Results Overview
The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.
Results posted on
2026-08-10
Participant Flow
This was a partially randomised, single-blind, placebo-controlled trial to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 3731579 administered as tablets to healthy male subjects.
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 group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
|
Dose Group (DG) 1, 6 mg BI 3731579
DG 1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 2, 21 mg BI 3731579
DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 3, 60mg BI 3731579
DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 4, 120mg BI 3731579
DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 5, 210mg BI 3731579
DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 6, 360mg BI 3731579
DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 7, 480mg BI 3731579
DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 8, 600mg BI 3731579
DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
15
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
This group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
|
Dose Group (DG) 1, 6 mg BI 3731579
n=6 Participants
DG 1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 2, 21 mg BI 3731579
n=6 Participants
DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 3, 60 mg BI 3731579
n=6 Participants
DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 4, 120 mg BI 3731579
n=6 Participants
DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 5, 210 mg BI 3731579
n=6 Participants
DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 6, 360 mg BI 3731579
n=6 Participants
DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 7, 480 mg BI 3731579
n=6 Participants
DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 8, 600 mg BI 3731579
n=6 Participants
DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.5 Years
STANDARD_DEVIATION 7.0 • n=54 Participants
|
34.2 Years
STANDARD_DEVIATION 7.9 • n=54 Participants
|
24.7 Years
STANDARD_DEVIATION 5.5 • n=27 Participants
|
34.3 Years
STANDARD_DEVIATION 10.6 • n=26 Participants
|
27.8 Years
STANDARD_DEVIATION 4.3 • n=161 Participants
|
35.8 Years
STANDARD_DEVIATION 8.1 • n=120 Participants
|
34.5 Years
STANDARD_DEVIATION 5.9 • n=18 Participants
|
29.2 Years
STANDARD_DEVIATION 6.1 • n=92 Participants
|
31.7 Years
STANDARD_DEVIATION 8.7 • n=106 Participants
|
32.0 Years
STANDARD_DEVIATION 7.6 • n=51 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=26 Participants
|
6 Participants
n=161 Participants
|
6 Participants
n=120 Participants
|
6 Participants
n=18 Participants
|
6 Participants
n=92 Participants
|
6 Participants
n=106 Participants
|
63 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=106 Participants
|
1 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=26 Participants
|
6 Participants
n=161 Participants
|
6 Participants
n=120 Participants
|
6 Participants
n=18 Participants
|
6 Participants
n=92 Participants
|
6 Participants
n=106 Participants
|
62 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=106 Participants
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=26 Participants
|
5 Participants
n=161 Participants
|
5 Participants
n=120 Participants
|
6 Participants
n=18 Participants
|
6 Participants
n=92 Participants
|
6 Participants
n=106 Participants
|
60 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=106 Participants
|
2 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.Population: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug and was used for the safety analyses.
The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator is reported.
Outcome measures
| Measure |
Placebo
n=15 Participants
This group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
|
Dose Group (DG) 1, 6 mg BI 3731579
n=6 Participants
DG1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 2, 21 mg BI 3731579
n=6 Participants
DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 3, 60 mg BI 3731579
n=6 Participants
DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 4, 120 mg BI 3731579
n=6 Participants
DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 5, 210 mg BI 3731579
n=6 Participants
DG 5 comprised participants DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 6, 360 mg BI 3731579
n=6 Participants
DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 7, 480 mg BI 3731579
n=6 Participants
DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 8, 600 mg BI 3731579
n=6 Participants
DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
|---|---|---|---|---|---|---|---|---|---|
|
Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.Population: The pharmacokinetic parameter analysis set (PKS) included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
AUC0-tz (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point) is reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
This group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
|
Dose Group (DG) 1, 6 mg BI 3731579
n=6 Participants
DG1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 2, 21 mg BI 3731579
n=6 Participants
DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 3, 60 mg BI 3731579
n=6 Participants
DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 4, 120 mg BI 3731579
n=6 Participants
DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 5, 210 mg BI 3731579
n=6 Participants
DG 5 comprised participants DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 6, 360 mg BI 3731579
n=6 Participants
DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 7, 480 mg BI 3731579
n=6 Participants
DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 8, 600 mg BI 3731579
DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC0-tz (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
|
595 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 15.4
|
3050 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 30.9
|
8360 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 42.6
|
21000 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 14.1
|
35700 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 27.4
|
79900 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 27.0
|
126000 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 18.4
|
123000 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 20.1
|
—
|
SECONDARY outcome
Timeframe: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.Population: The pharmacokinetic parameter analysis set (PKS) included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
AUC0-∞ (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 extrapolated to infinity) is reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
This group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
|
Dose Group (DG) 1, 6 mg BI 3731579
n=6 Participants
DG1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 2, 21 mg BI 3731579
n=6 Participants
DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 3, 60 mg BI 3731579
n=6 Participants
DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 4, 120 mg BI 3731579
n=6 Participants
DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 5, 210 mg BI 3731579
n=6 Participants
DG 5 comprised participants DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 6, 360 mg BI 3731579
n=6 Participants
DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 7, 480 mg BI 3731579
n=6 Participants
DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 8, 600 mg BI 3731579
DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC0-∞ (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
|
688 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 20.9
|
3220 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 31.4
|
8570 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 41.5
|
21300 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 13.3
|
36200 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 27.8
|
80900 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 27.0
|
127000 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 18.5
|
124000 hours·nanomoles/Liter (h·nmol/L)
Geometric Coefficient of Variation 20.2
|
—
|
SECONDARY outcome
Timeframe: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.Population: The PK parameter analysis set (PKS) included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability
Cmax (maximum measured concentration of BI 3731579 in plasma) is reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
This group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
|
Dose Group (DG) 1, 6 mg BI 3731579
n=6 Participants
DG1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 2, 21 mg BI 3731579
n=6 Participants
DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 3, 60 mg BI 3731579
n=6 Participants
DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 4, 120 mg BI 3731579
n=6 Participants
DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 5, 210 mg BI 3731579
n=6 Participants
DG 5 comprised participants DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 6, 360 mg BI 3731579
n=6 Participants
DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 7, 480 mg BI 3731579
n=6 Participants
DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 8, 600 mg BI 3731579
DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax (Maximum Measured Concentration of BI 3731579 in Plasma)
|
178 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 17.2
|
648 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 40.2
|
1730 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 44.0
|
3620 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 21.0
|
5180 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 40.5
|
10800 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 42.5
|
16600 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 12.4
|
15100 nanomoles/Liter (nmol/L)
Geometric Coefficient of Variation 17.8
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Group (DG) 1, 6mg BI 3731579
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DG 2, 21 mg BI 3731579
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DG 3, 60 mg BI 3731579
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DG 4, 120 mg BI 3731579
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DG 5, 210mg BI 3731579
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DG 6, 360mg BI 3731579
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DG 7, 480mg BI 3731579
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DG 8, 600mg BI 3731579
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=15 participants at risk
This group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
|
Dose Group (DG) 1, 6mg BI 3731579
n=6 participants at risk
DG1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 2, 21 mg BI 3731579
n=6 participants at risk
DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 3, 60 mg BI 3731579
n=6 participants at risk
DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 4, 120 mg BI 3731579
n=6 participants at risk
DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 5, 210mg BI 3731579
n=6 participants at risk
DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 6, 360mg BI 3731579
n=6 participants at risk
DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 7, 480mg BI 3731579
n=6 participants at risk
DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
DG 8, 600mg BI 3731579
n=6 participants at risk
DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
General disorders
Catheter site irritation
|
6.7%
1/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
General disorders
Fatigue
|
6.7%
1/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
General disorders
Puncture site pain
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Infections and infestations
Rhinitis
|
6.7%
1/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
33.3%
2/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
33.3%
2/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Nervous system disorders
Parosmia
|
6.7%
1/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
50.0%
3/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
33.3%
2/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Vascular disorders
Haematoma
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/15 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.
Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
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
- Publication restrictions are in place
Restriction type: OTHER