Trial Outcomes & Findings for A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood (NCT NCT03907280)
NCT ID: NCT03907280
Last Updated: 2022-07-06
Results Overview
Area under the concentration-time curve of BI 1265162 in plasma over the time interval from 0 extrapolated to infinity, dose-normalized to 1 µg BI 1265162, (AUC0-∞, norm). Time frame for treatment T1: Within 3 hours before and 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours following administration of the trial drug. Time frame for treatment T2 and T3: Within 3 hours before and 2, 5, 10, 15 and 40 minutes, 1, 2, 4, 8, 10, 12 and 24 hours following administration of the trial drug. Time frame for treatment R: Within 3 hours (h) before and 5, 30 and 59 minutes (min), 1 h 5 min, 1 h 10 min, 1 h 20 min, 1 h 40 min, 2, 2 h 30 min, 3, 3 h 30 min, 4, 5, 7, 9, 11, 13 and 24 hours following administration of the trial drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.
Results posted on
2022-07-06
Participant Flow
The trial was performed as a randomized, open-label, 3-way crossover trial followed by a fixed treatment in healthy male subjects in order to compare BI 1265162 given as oral solution (T1) and BI 1265162 inhaled via Respimat® with activated charcoal (T2) and without activated charcoal (fixed treatment, T3) compared with BI 1265162 given intravenously (R).
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 |
(T1-T2-R-T3) Treatment Sequence
In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
|
(R-T1-T2-T3) Treatment Sequence
In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
|
(T2-R-T1-T3) Treatment Sequence
In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
|
|---|---|---|---|
|
Treatment Period 1 + Washout Period 1
STARTED
|
4
|
4
|
4
|
|
Treatment Period 1 + Washout Period 1
Treated With BI 1265162
|
4
|
4
|
4
|
|
Treatment Period 1 + Washout Period 1
COMPLETED
|
4
|
4
|
4
|
|
Treatment Period 1 + Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 2 + Washout Period 2
STARTED
|
4
|
4
|
4
|
|
Treatment Period 2 + Washout Period 2
Treated With BI 1265162
|
4
|
4
|
4
|
|
Treatment Period 2 + Washout Period 2
COMPLETED
|
4
|
4
|
4
|
|
Treatment Period 2 + Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 3 + Washout Period 3
STARTED
|
4
|
4
|
4
|
|
Treatment Period 3 + Washout Period 3
Treated With BI 1265162
|
4
|
3
|
4
|
|
Treatment Period 3 + Washout Period 3
COMPLETED
|
4
|
3
|
4
|
|
Treatment Period 3 + Washout Period 3
NOT COMPLETED
|
0
|
1
|
0
|
|
Treatment Period 4: Fixed Treatment T3
STARTED
|
4
|
4
|
4
|
|
Treatment Period 4: Fixed Treatment T3
Treated With BI 1265162
|
4
|
4
|
4
|
|
Treatment Period 4: Fixed Treatment T3
COMPLETED
|
4
|
4
|
4
|
|
Treatment Period 4: Fixed Treatment T3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
(T1-T2-R-T3) Treatment Sequence
In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
|
(R-T1-T2-T3) Treatment Sequence
In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
|
(T2-R-T1-T3) Treatment Sequence
In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
|
|---|---|---|---|
|
Treatment Period 3 + Washout Period 3
Not treated with BI 1265162 because of Serious Adverse Event in Treatment Period 2
|
0
|
1
|
0
|
Baseline Characteristics
A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood
Baseline characteristics by cohort
| Measure |
(T1-T2-R-T3) Treatment Sequence
n=4 Participants
In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
|
(R-T1-T2-T3) Treatment Sequence
n=4 Participants
In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
|
(T2-R-T1-T3) Treatment Sequence
n=4 Participants
In this randomized, 3-way crossover trial followed by a fixed treatment participants were randomized to one of 3 possible treatment sequences. Treatments administered were 1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (h) (Test treatment 1, T1), 200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 h in combination with activated charcoal (Test treatment 2, T2) and without activated charcoal (Fixed treatment, Test treatment 3, T3), 50 μg of BI 1265162 concentrate for infusion (2 mL of 25 μg/mL) administered intravenously over 1 h after an overnight fast of at least 8 h (Reference treatment, R). Each treatment was administered as a single dose and a washout period of at least 6 days was adhered to between drug administrations.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 9.5 • n=4 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
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 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
|
|
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
|
PRIMARY outcome
Timeframe: Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.Population: Pharmacokinetic (PK) parameter analysis set (PKS): All participants who were randomized and treated with at least 1 dose of any trial drug and who provided at least 1 PK endpoint being defined as primary or further and who were 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 1265162 in plasma over the time interval from 0 extrapolated to infinity, dose-normalized to 1 µg BI 1265162, (AUC0-∞, norm). Time frame for treatment T1: Within 3 hours before and 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours following administration of the trial drug. Time frame for treatment T2 and T3: Within 3 hours before and 2, 5, 10, 15 and 40 minutes, 1, 2, 4, 8, 10, 12 and 24 hours following administration of the trial drug. Time frame for treatment R: Within 3 hours (h) before and 5, 30 and 59 minutes (min), 1 h 5 min, 1 h 10 min, 1 h 20 min, 1 h 40 min, 2, 2 h 30 min, 3, 3 h 30 min, 4, 5, 7, 9, 11, 13 and 24 hours following administration of the trial drug.
Outcome measures
| Measure |
BI 1265162 as Infusion (R)
n=12 Participants
50 microgram (μg) of BI 1265162 concentrate for infusion (2 milliliter (mL) of 25 μg/mL) administered intravenously over 1 hour after an overnight fast of at least 8 hours (Reference treatment, R).
|
BI 1265162 as Oral Solution (T1)
n=12 Participants
1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (Test treatment 1, T1).
|
BI 1265162 for Inhalation With Activated Charcoal (T2)
n=11 Participants
200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours in combination with activated charcoal (Test treatment 2, T2).
|
BI 1265162 for Inhalation Without Activated Charcoal (T3)
n=12 Participants
200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours without activated charcoal (Fixed treatment, Test treatment 3, T3).
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm)
|
44.63 ((hour * millimole) / liter) / kilogram
Standard Error NA
Standard Error is geometric Standard Error (gSE) = 1.11.
|
0.22 ((hour * millimole) / liter) / kilogram
Standard Error NA
Standard Error is geometric Standard Error (gSE) = 1.11.
|
17.97 ((hour * millimole) / liter) / kilogram
Standard Error NA
Standard Error is geometric Standard Error (gSE) = 1.11.
|
17.96 ((hour * millimole) / liter) / kilogram
Standard Error NA
Standard Error is geometric Standard Error (gSE) = 1.11.
|
Adverse Events
BI 1265162 as Infusion (R)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 1265162 as Oral Solution (T1)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1265162 for Inhalation With Activated Charcoal (T2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 1265162 for Inhalation Without Activated Charcoal (T3)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 1265162 as Infusion (R)
n=12 participants at risk
50 microgram (μg) of BI 1265162 concentrate for infusion (2 milliliter (mL) of 25 μg/mL) administered intravenously over 1 hour after an overnight fast of at least 8 hours (Reference treatment, R).
|
BI 1265162 as Oral Solution (T1)
n=12 participants at risk
1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (Test treatment 1, T1).
|
BI 1265162 for Inhalation With Activated Charcoal (T2)
n=11 participants at risk
200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours in combination with activated charcoal (Test treatment 2, T2).
|
BI 1265162 for Inhalation Without Activated Charcoal (T3)
n=12 participants at risk
200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours without activated charcoal (Fixed treatment, Test treatment 3, T3).
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/12 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
8.3%
1/12 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
0.00%
0/11 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
0.00%
0/12 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
Other adverse events
| Measure |
BI 1265162 as Infusion (R)
n=12 participants at risk
50 microgram (μg) of BI 1265162 concentrate for infusion (2 milliliter (mL) of 25 μg/mL) administered intravenously over 1 hour after an overnight fast of at least 8 hours (Reference treatment, R).
|
BI 1265162 as Oral Solution (T1)
n=12 participants at risk
1.25 milligram (mg) of BI 1265162 as oral solution (5 milliliter (mL) of 0.25 mg/mL) administered orally with 240 mL of water after an overnight fast of at least 8 hours (Test treatment 1, T1).
|
BI 1265162 for Inhalation With Activated Charcoal (T2)
n=11 participants at risk
200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours in combination with activated charcoal (Test treatment 2, T2).
|
BI 1265162 for Inhalation Without Activated Charcoal (T3)
n=12 participants at risk
200 microgram (μg) of BI 1265162 as solution for inhalation (2 actuations of 100 μg) inhaled by Respimat® after an overnight fast of at least 8 hours without activated charcoal (Fixed treatment, Test treatment 3, T3).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
8.3%
1/12 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
0.00%
0/11 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
0.00%
0/12 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
8.3%
1/12 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
0.00%
0/11 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
8.3%
1/12 • For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.
Treated set (TS): All participants who were randomized and treated with at least 1 dose of any trial drug.
|
Additional Information
Boehringer Ingelheim , Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place