Trial Outcomes & Findings for A Study in Healthy Men and Women to Test Which Effects Donepezil and BI 425809 Have on Each Other (NCT NCT03905096)
NCT ID: NCT03905096
Last Updated: 2021-02-17
Results Overview
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) plasma concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Detailed time frame is in the description section
Results posted on
2021-02-17
Participant Flow
This is an open-label, two-treatment, two-period, one fixed sequence cross-over design study in order to investigate the effects of donepezil (Don) on the pharmacokinetics (PK) of BI 425809 (trial part 1) and vice versa (trial part 2) in healthy male and female subjects over a period up to 57 days in part 1 and up to 55 days in part 2.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Trial Part 1: BI 425809 / Donepezil + BI 425809
All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 (Treatment A, Reference 1) and on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg once a day (qd) (1 tablet) on day 1 to 7 of visit 3 and 10 mg qd (2 tablets) on day 8 to 28 of visit 3 (Treatment B, Test 1) in the fasted state with about 240 milliliters (ml) of fluid.
|
Trial Part 2: Donepezil / BI 425809 + Donepezil
All participants were orally administered a single dose of donepezil, 10 mg film-coated tablet on day 1 of visit 2 (Treatment C, Reference 2) and on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd (1 tablet) on day 1 to 24 of visit 3 (Treatment D, Test 2) in the fasted state with about 240 milliliters (ml) of fluid.
|
|---|---|---|
|
Period 1 for Trial Part 1 and 2
STARTED
|
18
|
14
|
|
Period 1 for Trial Part 1 and 2
COMPLETED
|
18
|
14
|
|
Period 1 for Trial Part 1 and 2
NOT COMPLETED
|
0
|
0
|
|
Period 2 for Trial Part 1 and 2
STARTED
|
18
|
14
|
|
Period 2 for Trial Part 1 and 2
COMPLETED
|
17
|
14
|
|
Period 2 for Trial Part 1 and 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Trial Part 1: BI 425809 / Donepezil + BI 425809
All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 (Treatment A, Reference 1) and on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg once a day (qd) (1 tablet) on day 1 to 7 of visit 3 and 10 mg qd (2 tablets) on day 8 to 28 of visit 3 (Treatment B, Test 1) in the fasted state with about 240 milliliters (ml) of fluid.
|
Trial Part 2: Donepezil / BI 425809 + Donepezil
All participants were orally administered a single dose of donepezil, 10 mg film-coated tablet on day 1 of visit 2 (Treatment C, Reference 2) and on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd (1 tablet) on day 1 to 24 of visit 3 (Treatment D, Test 2) in the fasted state with about 240 milliliters (ml) of fluid.
|
|---|---|---|
|
Period 2 for Trial Part 1 and 2
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study in Healthy Men and Women to Test Which Effects Donepezil and BI 425809 Have on Each Other
Baseline characteristics by cohort
| Measure |
Trial Part 1: BI 425809 / Donepezil + BI 425809
n=18 Participants
All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 (Treatment A, Reference 1) and on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg once a day (qd) (1 tablet) on day 1 to 7 of visit 3 and 10 mg qd (2 tablets) on day 8 to 28 of visit 3 (Treatment B, Test 1) in the fasted state with about 240 milliliters (ml) of fluid.
|
Trial Part 2: Donepezil / BI 425809 + Donepezil
n=14 Participants
All participants were orally administered a single dose of donepezil, 10 mg film-coated tablet on day 1 of visit 2 (Treatment C, Reference 2) and on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd (1 tablet) on day 1 to 24 of visit 3 (Treatment D, Test 2) in the fasted state with about 240 milliliters (ml) of fluid.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.1 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
35.9 Years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
37.7 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Detailed time frame is in the description sectionPopulation: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) plasma concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil.
Outcome measures
| Measure |
Don Alone Group (Part 2: Treatment C, Reference 2)
n=17 Participants
All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2).
|
Don + BI 425809 Group (Part 2: Treatment D, Test 2)
n=15 Participants
All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
11815.37 nanomoles * hours per liter
Standard Error 1.10
|
10944.06 nanomoles * hours per liter
Standard Error 1.10
|
PRIMARY outcome
Timeframe: Detailed time frame is in the description sectionPopulation: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of donepezil in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For donepezil alone (Part 2: Treatment C, Reference 2) and donepezil + BI 425809 (Part 2: Treatment D, Test 2) concentrations of donepezil were measured within 2 hours (h) before and at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h, 264h, 288h, 312h, 336h, after administration of donepezil alone or in combination with BI 425809.
Outcome measures
| Measure |
Don Alone Group (Part 2: Treatment C, Reference 2)
n=10 Participants
All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2).
|
Don + BI 425809 Group (Part 2: Treatment D, Test 2)
n=12 Participants
All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
|
|---|---|---|
|
Area Under the Concentration-time Curve of Donepezil in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
647.16 nanograms * hours per milliliter
Standard Error 1.09
|
638.38 nanograms * hours per milliliter
Standard Error 1.09
|
PRIMARY outcome
Timeframe: Detailed time frame is in the description sectionPopulation: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 425809 in plasma (Cmax). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil.
Outcome measures
| Measure |
Don Alone Group (Part 2: Treatment C, Reference 2)
n=17 Participants
All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2).
|
Don + BI 425809 Group (Part 2: Treatment D, Test 2)
n=15 Participants
All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
|
|---|---|---|
|
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
|
293.97 nanomoles per liter
Standard Error 1.07
|
289.51 nanomoles per liter
Standard Error 1.08
|
PRIMARY outcome
Timeframe: Detailed time frame is in the description sectionPopulation: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of donepezil in plasma (Cmax). For donepezil alone (Part 2: Treatment C, Reference 2) and donepezil + BI 425809 (Part 2: Treatment D, Test 2) concentrations of donepezil were measured withing 2 hours (h) before and at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h, 264h, 288h, 312h, 336h, after administration of donepezil alone or in combination with BI 425809.
Outcome measures
| Measure |
Don Alone Group (Part 2: Treatment C, Reference 2)
n=10 Participants
All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2).
|
Don + BI 425809 Group (Part 2: Treatment D, Test 2)
n=12 Participants
All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
|
|---|---|---|
|
Maximum Measured Concentration of Donepezil in Plasma (Cmax)
|
15.94 nanograms per milliliter
Standard Error 1.12
|
15.96 nanograms per milliliter
Standard Error 1.12
|
SECONDARY outcome
Timeframe: Detailed time frame is in the description sectionPopulation: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For BI 425809 alone (Part 1: Treatment A, Reference 1) and BI 425809 + donepezil (Part 1: Treatment B, Test 1) concentrations of BI 425809 were measured within 2 hours (h) before and at 30 minutes (min), 1 h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h after administration of BI 425809 alone or in combination with donepezil.
Outcome measures
| Measure |
Don Alone Group (Part 2: Treatment C, Reference 2)
n=17 Participants
All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2).
|
Don + BI 425809 Group (Part 2: Treatment D, Test 2)
n=15 Participants
All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
10638.64 nanomoles * hours per liter
Standard Error 1.08
|
10082.12 nanomoles * hours per liter
Standard Error 1.08
|
SECONDARY outcome
Timeframe: Detailed time frame is in the description sectionPopulation: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For donepezil alone (Part 2: Treatment C, Reference 2) and donepezil + BI 425809 (Part 2: Treatment D, Test 2) concentrations of donepezil were measured within 2 hours (h) before and at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h, 264h, 288h, 312h, 336h, after administration of donepezil alone or in combination with BI 425809.
Outcome measures
| Measure |
Don Alone Group (Part 2: Treatment C, Reference 2)
n=10 Participants
All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2).
|
Don + BI 425809 Group (Part 2: Treatment D, Test 2)
n=12 Participants
All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
|
|---|---|---|
|
Area Under the Concentration-time Curve of Donepezil in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
600.86 nanograms * hours per milliliter
Standard Error 1.10
|
601.20 nanograms * hours per milliliter
Standard Error 1.10
|
Adverse Events
BI 425809 Alone Group (Part 1: Treatment A, Reference 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Donepezil Group (Part 1: Treatment B, Test 1)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
BI 425809 + Donepezil Group (Part 1: Treatment B, Test 1)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Donepezil Alone Group (Part 2: Treatment C, Reference 2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 425809 Group (Part 2: Treatment D, Test 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Donepezil + BI 425809 Group (Part 2: Treatment D, Test 2)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 425809 Alone Group (Part 1: Treatment A, Reference 1)
n=18 participants at risk
All participants were orally administered a single dose of BI 425809, 25 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment A, Reference 1).
|
Donepezil Group (Part 1: Treatment B, Test 1)
n=18 participants at risk
All participants were orally administered multiple doses of donepezil, film-coated tablets, 5 mg (1 tablet) qd on day 1 to 7 and 10 mg (2 tablets) qd on day 8 to 29 of visit 3 in the fasted state with about 240 ml of fluid (Treatment B, Test 1).
|
BI 425809 + Donepezil Group (Part 1: Treatment B, Test 1)
n=18 participants at risk
All participants were orally administered a single dose of BI 425809, 25 mg, film-coated tablet, on day 22 of visit 3, together with multiple doses of donepezil, film-coated tablets, 5 mg (1 tablet) qd on day 1 to 7 and 10 mg (2 tablets) qd on day 8 to 29 of visit 3 in the fasted state with about 240 ml of fluid (Treatment B, Test 1).
|
Donepezil Alone Group (Part 2: Treatment C, Reference 2)
n=14 participants at risk
All participants were orally administered a single dose of donepezil, 10 milligrams (mg) film-coated tablet on day 1 of visit 2 in the fasted state with about 240 milliliters (ml) of fluid (Treatment C, Reference 2).
|
BI 425809 Group (Part 2: Treatment D, Test 2)
n=14 participants at risk
All participants were orally administered multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
|
Donepezil + BI 425809 Group (Part 2: Treatment D, Test 2)
n=14 participants at risk
All participants were orally administered a single dose of donepezil, 10 mg, film-coated tablet, on day 10 of visit 3, together with multiple doses of BI 425809, film-coated tablets, 25 mg qd on day 1 to 24 of visit 3 in the fasted state with about 240 ml of fluid (Treatment D, Test 2).
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
33.3%
6/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
27.8%
5/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
14.3%
2/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
42.9%
6/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
27.8%
5/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
22.2%
4/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
14.3%
2/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
21.4%
3/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Syncope
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
50.0%
9/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
27.8%
5/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
21.4%
3/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
35.7%
5/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
11.1%
2/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
28.6%
4/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
14.3%
2/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
11.1%
2/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
27.8%
5/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
General disorders
Fatigue
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
16.7%
3/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
General disorders
Feeling hot
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
General disorders
Malaise
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Psychiatric disorders
Sleep disorder
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
16.7%
3/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Psychiatric disorders
Abnormal dreams
|
11.1%
2/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
11.1%
2/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
7.1%
1/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
5.6%
1/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/18 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
0.00%
0/14 • The adverse events collection time frame for BI 425809 part 1 is 8 days, for donepezil part 1 it is 28 days, and for donepezil + BI 425809 part 1 it is 14 days. The adverse events collection time frame for donepezil part 2 is 15 days, for BI 425809 part 2 it is 19 days, and for BI 425809 + donepezil part 2 it is 15 days.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
|
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