Trial Outcomes & Findings for A Study in Healthy Men to Test How BI 474121 is Tolerated (NCT NCT04964453)
NCT ID: NCT04964453
Last Updated: 2024-03-07
Results Overview
Percentage of subjects with investigator-defined drug-related adverse events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days.
Results posted on
2024-03-07
Participant Flow
This was a trial with a randomised within dose groups, placebo-controlled, double-blind, parallel group design to investigate safety, tolerability, and pharmacokinetics following single rising doses of BI 474121.
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
Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
2.5 mg BI 474121
Healthy subjects were given a single dose of 2.5 milligram (mg) of BI 474121 as a single (2.5 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
5 mg BI 474121
Healthy subjects were given a single dose of 5 milligram (mg) of BI 474121 as two (2.5 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
10 mg BI 474121
Healthy subjects were given a single dose of 10 milligram (mg) of BI 474121 as a single (10 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
20 mg BI 474121
Healthy subjects were given a single dose of 20 milligram (mg) of BI 474121 as two (10 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How BI 474121 is Tolerated
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
2.5 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 2.5 milligram (mg) of BI 474121 as a single (2.5 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
5 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 5 milligram (mg) of BI 474121 as two (2.5 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
10 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 10 milligram (mg) of BI 474121 as a single (10 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
20 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 20 milligram (mg) of BI 474121 as two (10 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
27.0 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
32.3 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
36.5 years
STANDARD_DEVIATION 9.4 • n=21 Participants
|
31.8 years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days.Population: Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
Percentage of subjects with investigator-defined drug-related adverse events (AEs).
Outcome measures
| Measure |
Placebo
n=8 Participants
Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
2.5 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 2.5 milligram (mg) of BI 474121 as a single (2.5 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
5 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 5 milligram (mg) of BI 474121 as two (2.5 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
10 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 10 milligram (mg) of BI 474121 as a single (10 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
20 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 20 milligram (mg) of BI 474121 as two (10 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Drug-related Adverse Events (AEs)
|
25 Percentage of participants
|
0 Percentage of participants
|
16.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were randomised and treated with at least one dose of study drug and who provided at least one pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
Placebo
n=6 Participants
Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
2.5 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 2.5 milligram (mg) of BI 474121 as a single (2.5 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
5 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 5 milligram (mg) of BI 474121 as two (2.5 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
10 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 10 milligram (mg) of BI 474121 as a single (10 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
20 mg BI 474121
Healthy subjects were given a single dose of 20 milligram (mg) of BI 474121 as two (10 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
289 hour*nanomole/liter
Geometric Coefficient of Variation 25.6
|
658 hour*nanomole/liter
Geometric Coefficient of Variation 21.2
|
1440 hour*nanomole/liter
Geometric Coefficient of Variation 15.4
|
2330 hour*nanomole/liter
Geometric Coefficient of Variation 25.4
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were randomised and treated with at least one dose of study drug and who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 474121 in plasma (Cmax).
Outcome measures
| Measure |
Placebo
n=6 Participants
Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
2.5 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 2.5 milligram (mg) of BI 474121 as a single (2.5 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
5 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 5 milligram (mg) of BI 474121 as two (2.5 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
10 mg BI 474121
n=6 Participants
Healthy subjects were given a single dose of 10 milligram (mg) of BI 474121 as a single (10 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
20 mg BI 474121
Healthy subjects were given a single dose of 20 milligram (mg) of BI 474121 as two (10 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 474121 in Plasma (Cmax)
|
27.0 nanomole/liter
Geometric Coefficient of Variation 20.6
|
54.3 nanomole/liter
Geometric Coefficient of Variation 13.5
|
113 nanomole/liter
Geometric Coefficient of Variation 11.2
|
193 nanomole/liter
Geometric Coefficient of Variation 16.7
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
2.5 mg BI 474121
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
5 mg BI 474121
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mg BI 474121
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
20 mg BI 474121
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
2.5 mg BI 474121
n=6 participants at risk
Healthy subjects were given a single dose of 2.5 milligram (mg) of BI 474121 as a single (2.5 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
5 mg BI 474121
n=6 participants at risk
Healthy subjects were given a single dose of 5 milligram (mg) of BI 474121 as two (2.5 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
10 mg BI 474121
n=6 participants at risk
Healthy subjects were given a single dose of 10 milligram (mg) of BI 474121 as a single (10 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
20 mg BI 474121
n=6 participants at risk
Healthy subjects were given a single dose of 20 milligram (mg) of BI 474121 as two (10 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
33.3%
2/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/8 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Nervous system disorders
Orthostatic intolerance
|
25.0%
2/8 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • Adverse events: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days. All-cause mortality: From the time of first administration of study medication until end of trial, up to 15 days.
Treated set (TS): all subjects who were randomised and treated with at least one dose of study 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 Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER