Trial Outcomes & Findings for Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects (NCT NCT02635750)
NCT ID: NCT02635750
Last Updated: 2024-08-20
Results Overview
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter.
Results posted on
2024-08-20
Participant Flow
Part I (18 subjects entered) of this trial was performed as a one fixed sequence, open-label trial; single doses of BI 409306 and multiple doses of donepezil were administered. Part II (14 subjects entered) was performed as a randomised, open-label, 2-way crossover trial; single doses of donepezil and multiple doses of BI 409306 were administered.
All subjects were screened for eligibility to participate in the trial. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated. Removal of individual subjects if the subject withdrew consent for trial treatment or trial participation, without the need to justify the decision.
Participant milestones
| Measure |
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg Donepezil (T1)
This arm is used in part 1 of this trial only. The subjects received the treatments in a fixed sequence: Reference treatment (R1) / test treatment (T1). The test treatment (T1) was administered after preceding treatment with donepezil for 21 days.
On day 1 of period 1, one film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (R1).
In period 2, day 1 to 7, subjects received one film-coated tablet of 5 mg donepezil administered orally once daily, followed by 2 film-coated tablets of 5 mg (total: 10 mg) donepezil once daily on day 8 to 21 (up-titration regime).
On day 1 of period 3, one film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (T1). There was no washout periods between the visits.
|
Part 2: 5 mg Donepezil (R2) / 5 mg Donepezil + 100 mg BI 409306 (T2)
This arm is used in part 2 of this trial only. Each subject received first the reference treatment (R2) followed by a washout period of at least 25 days, followed by the test treatment (T2). On day 1 of period 1, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state, followed by a washout period of at least 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 2, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily.
|
Part 2: 5 mg Donepezil + 100 mg BI 409306 (T2) / 5mg Donepezil (R2)
This arm is used in part 2 of this trial only. Each subject received first the test treatment (T2) followed by a washout period of at least 25 days, followed by the reference treatment (R2).
On day 1 of period 1, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 1, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily, followed by a washout period of 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state.
|
|---|---|---|---|
|
Part 1, Period 1
STARTED
|
18
|
0
|
0
|
|
Part 1, Period 1
COMPLETED
|
18
|
0
|
0
|
|
Part 1, Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Part 1, Period 2
STARTED
|
18
|
0
|
0
|
|
Part 1, Period 2
COMPLETED
|
17
|
0
|
0
|
|
Part 1, Period 2
NOT COMPLETED
|
1
|
0
|
0
|
|
Part 1, Period 3
STARTED
|
17
|
0
|
0
|
|
Part 1, Period 3
COMPLETED
|
17
|
0
|
0
|
|
Part 1, Period 3
NOT COMPLETED
|
0
|
0
|
0
|
|
Part 2, Period 1
STARTED
|
0
|
7
|
7
|
|
Part 2, Period 1
COMPLETED
|
0
|
7
|
7
|
|
Part 2, Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Part 2, Washout
STARTED
|
0
|
7
|
7
|
|
Part 2, Washout
COMPLETED
|
0
|
7
|
7
|
|
Part 2, Washout
NOT COMPLETED
|
0
|
0
|
0
|
|
Part 2, Period 2
STARTED
|
0
|
7
|
7
|
|
Part 2, Period 2
COMPLETED
|
0
|
7
|
7
|
|
Part 2, Period 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg Donepezil (T1)
This arm is used in part 1 of this trial only. The subjects received the treatments in a fixed sequence: Reference treatment (R1) / test treatment (T1). The test treatment (T1) was administered after preceding treatment with donepezil for 21 days.
On day 1 of period 1, one film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (R1).
In period 2, day 1 to 7, subjects received one film-coated tablet of 5 mg donepezil administered orally once daily, followed by 2 film-coated tablets of 5 mg (total: 10 mg) donepezil once daily on day 8 to 21 (up-titration regime).
On day 1 of period 3, one film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (T1). There was no washout periods between the visits.
|
Part 2: 5 mg Donepezil (R2) / 5 mg Donepezil + 100 mg BI 409306 (T2)
This arm is used in part 2 of this trial only. Each subject received first the reference treatment (R2) followed by a washout period of at least 25 days, followed by the test treatment (T2). On day 1 of period 1, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state, followed by a washout period of at least 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 2, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily.
|
Part 2: 5 mg Donepezil + 100 mg BI 409306 (T2) / 5mg Donepezil (R2)
This arm is used in part 2 of this trial only. Each subject received first the test treatment (T2) followed by a washout period of at least 25 days, followed by the reference treatment (R2).
On day 1 of period 1, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 1, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily, followed by a washout period of 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state.
|
|---|---|---|---|
|
Part 1, Period 2
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects
Baseline characteristics by cohort
| Measure |
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg Donepezil (T1)
n=18 Participants
This arm is used in part 1 of this trial only. The subjects received the treatments in a fixed sequence: Reference treatment (R1) / test treatment (T1). The test treatment (T1) was administered after preceding treatment with donepezil for 21 days.
On day 1 of period 1, one film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (R1).
In period 2, day 1 to 7, subjects received one film-coated tablet of 5 mg donepezil administered orally once daily, followed by 2 film-coated tablets of 5 mg (total: 10 mg) donepezil once daily on day 8 to 21 (up-titration regime).
On day 1 of period 3, one film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (T1). There was no washout periods between the visits.
|
Part 2: 5 mg Donepezil (R2) / 5 mg Donepezil + 100 mg BI 409306 (T2)
n=7 Participants
This arm is used in part 2 of this trial only. Each subject received first the reference treatment (R2) followed by a washout period of at least 25 days, followed by the test treatment (T2). On day 1 of period 1, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state, followed by a washout period of at least 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 2, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily.
|
Part 2: 5 mg Donepezil + 100 mg BI 409306 (T2) / 5mg Donepezil (R2)
n=7 Participants
This arm is used in part 2 of this trial only. Each subject received first the test treatment (T2) followed by a washout period of at least 25 days, followed by the reference treatment (R2).
On day 1 of period 1, one film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (T2) were administered orally with 240 ml of water in the morning in fasted state. From day 2 to day 7 in period 1, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily, followed by a washout period of 25 days. On day 1 of period 2, one film-coated tablet of 5 mg donepezil (R2) was administered as single oral dose with 240 mL of water in the morning in fasted state.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.7 Years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
45.1 Years
STANDARD_DEVIATION 8.8 • n=107 Participants
|
36.9 Years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
42.5 Years
STANDARD_DEVIATION 8.7 • n=157 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
17 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter.Population: Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. Only participants with non-missing results are reported.
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point.
Outcome measures
| Measure |
25 mg BI 409306
n=18 Participants
One film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (reference treatment 1 (R1)).
|
25 mg BI 409306 + 10 mg Donepezil
n=17 Participants
One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)).
|
|---|---|---|
|
Part 1: AUC0-tz of BI 409306
|
603 nanomol (nmol)*hour (h)/Litre (L)
Geometric Coefficient of Variation 95.4
|
643 nanomol (nmol)*hour (h)/Litre (L)
Geometric Coefficient of Variation 86.2
|
PRIMARY outcome
Timeframe: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.Population: Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. Only participants with non-missing results are reported.
Maximum measured concentration of the BI 409306 in plasma.
Outcome measures
| Measure |
25 mg BI 409306
n=18 Participants
One film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (reference treatment 1 (R1)).
|
25 mg BI 409306 + 10 mg Donepezil
n=17 Participants
One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)).
|
|---|---|---|
|
Part 1: Cmax of BI 409306
|
268 nmol/L
Geometric Coefficient of Variation 86.2
|
286 nmol/L
Geometric Coefficient of Variation 47.8
|
PRIMARY outcome
Timeframe: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.Population: Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations.
Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point.
Outcome measures
| Measure |
25 mg BI 409306
n=14 Participants
One film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (reference treatment 1 (R1)).
|
25 mg BI 409306 + 10 mg Donepezil
n=14 Participants
One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)).
|
|---|---|---|
|
Part 2: AUC0-tz of Donepezil
|
299 nanogram (ng)*h/ millilitre (mL)
Geometric Coefficient of Variation 20.4
|
301 nanogram (ng)*h/ millilitre (mL)
Geometric Coefficient of Variation 20.6
|
PRIMARY outcome
Timeframe: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.Population: Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations.
Maximum measured concentration of the donepezil in plasma.
Outcome measures
| Measure |
25 mg BI 409306
n=14 Participants
One film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (reference treatment 1 (R1)).
|
25 mg BI 409306 + 10 mg Donepezil
n=14 Participants
One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)).
|
|---|---|---|
|
Part 2: Cmax of Donepezil
|
6.23 ng/mL
Geometric Coefficient of Variation 27.5
|
7.04 ng/mL
Geometric Coefficient of Variation 30.0
|
SECONDARY outcome
Timeframe: At approximate 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.Population: Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. Only participants with non-missing results are reported.
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity.
Outcome measures
| Measure |
25 mg BI 409306
n=18 Participants
One film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (reference treatment 1 (R1)).
|
25 mg BI 409306 + 10 mg Donepezil
n=17 Participants
One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)).
|
|---|---|---|
|
Part 1: AUC 0-infinity of BI 409306
|
604 nmol*h/L
Geometric Coefficient of Variation 95.5
|
644 nmol*h/L
Geometric Coefficient of Variation 86.4
|
SECONDARY outcome
Timeframe: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.Population: Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations.
This outcome measure presents the area under the concentration-time curve of donepezil in plasma over the time interval from 0 extrapolated to infinity.
Outcome measures
| Measure |
25 mg BI 409306
n=14 Participants
One film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (reference treatment 1 (R1)).
|
25 mg BI 409306 + 10 mg Donepezil
n=14 Participants
One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)).
|
|---|---|---|
|
Part 2: AUC0-infinity of Donepezil
|
386 ng*h/mL
Geometric Coefficient of Variation 29.9
|
380 ng*h/mL
Geometric Coefficient of Variation 23.4
|
Adverse Events
Part 1: 25 mg BI 409306
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1: 5 mg Donepezil /10 mg Donepezil
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Part 1: 25 mg BI 409306 25mg + 10 mg Donepezil
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: 5 mg Donepezil
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: 5mg Donepezil + 100 mg BI 409306
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: 25 mg BI 409306
n=18 participants at risk
One film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (reference treatment 1 (R1)).
|
Part 1: 5 mg Donepezil /10 mg Donepezil
n=18 participants at risk
Period 2: On day 1 to 7, subjects received one film-coated tablet of 5 mg donepezil administered orally once daily, followed by 2 film-coated tablets of 5 mg (total: 10 mg) donepezil once daily on day 8 to 21.
|
Part 1: 25 mg BI 409306 25mg + 10 mg Donepezil
n=17 participants at risk
Period 3: One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)).
|
Part 2: 5 mg Donepezil
n=14 participants at risk
One film-coated tablet of 5 mg donepezil (reference treatment 2 (R2)) was administered as single oral dose with 240 mL of water in the morning in fasted state.
|
Part 2: 5mg Donepezil + 100 mg BI 409306
n=14 participants at risk
One film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (test treatment 2 (T2)) were administered orally with 240 ml of water in the morning in fasted state on day 1. From day 2 to day 7, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.9%
1/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Chromatopsia
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
28.6%
4/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Photopsia
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
35.7%
5/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
16.7%
3/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Visual brightness
|
11.1%
2/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
21.4%
3/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
35.7%
5/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
11.1%
2/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Faeces hard
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
55.6%
10/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
11.8%
2/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
28.6%
4/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
11.1%
2/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.9%
1/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
General disorders
Fatigue
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
16.7%
3/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.9%
1/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
General disorders
Vessel puncture site thrombosis
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
11.1%
2/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
11.8%
2/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Investigations
Occult blood positive
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
14.3%
2/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
55.6%
10/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
21.4%
3/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
16.7%
3/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.9%
1/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
21.4%
3/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
11.1%
2/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
7.1%
1/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
5.6%
1/18 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/17 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/14 • From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER