Trial Outcomes & Findings for BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease. (NCT NCT02337907)
NCT ID: NCT02337907
Last Updated: 2018-11-14
Results Overview
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Least Squares Mean is actually an adjusted mean change from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
329 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2018-11-14
Participant Flow
This was a Phase II, multi-centre, double-blind, parallel-group, randomised, placebo controlled trial with patients with mild Alzheimer's disease. The randomisation allocation ratio was 1:1:1:1:2 of 10 milligram (mg), 25 mg, 50 mg once daily (QD), 25 mg twice a day (BID) of BI 409306 and placebo respectively.
All patients were screened for eligibility. All patients eligible after screening underwent a 2-week single-blind placebo run-in period before randomisation. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
Donepezil QD
Patients were administered orally over capsulated tablet of Donepezil once daily for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
53
|
55
|
55
|
106
|
5
|
|
Overall Study
COMPLETED
|
51
|
49
|
54
|
51
|
96
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
1
|
4
|
10
|
1
|
Reasons for withdrawal
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
Donepezil QD
Patients were administered orally over capsulated tablet of Donepezil once daily for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Other than listed
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
0
|
2
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
1
|
4
|
0
|
Baseline Characteristics
BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Baseline characteristics by cohort
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=55 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=53 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=55 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=55 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
n=106 Participants
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
Donepezil QD
n=5 Participants
Patients were administered orally over capsulated tablet of Donepezil once daily for 12 weeks.
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.7 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
74.2 Years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
73.0 Years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
74.8 Years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
74.0 Years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
79.6 Years
STANDARD_DEVIATION 7.0 • n=8 Participants
|
74.0 Years
STANDARD_DEVIATION 7.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
163 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
166 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
316 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
324 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: The full analysis set (FAS): FAS includes all randomised patients who were treated with at least one dose of trial medication and had a baseline and at least one post-baseline on-treatment primary endpoint NTB or secondary endpoint assessment. Observed cases (OC)
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Least Squares Mean is actually an adjusted mean change from baseline.
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=54 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=50 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=55 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=55 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=214 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
n=101 Participants
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment.
|
0.13 Z-score
Standard Error 0.059
|
0.17 Z-score
Standard Error 0.061
|
0.16 Z-score
Standard Error 0.056
|
0.01 Z-score
Standard Error 0.060
|
0.12 Z-score
Standard Error 0.30
|
0.15 Z-score
Standard Error 0.045
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS (OC) and for pooled group FAS
Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. The number of low test scores decreased with higher levels of intellectual abilities. Least Squares Mean is actually an adjusted mean change from baseline.
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=76 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=71 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=76 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=76 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=299 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
n=144 Participants
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment From Two Sister Trials, Present 1289.5 (NCT02240693) and 1289.7 (NCT02337907)
|
0.20 Z-score
Standard Error 0.046
|
0.19 Z-score
Standard Error 0.048
|
0.19 Z-score
Standard Error 0.046
|
0.10 Z-score
Standard Error 0.047
|
0.17 Z-score
Standard Error 0.025
|
0.19 Z-score
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) is a rating scale used to assess basic and instrumental activities of daily living. In the full version of the scale, 23 items are rated by the investigator using information supplied by the caregiver. Each item has a score range varying from 0-3 to 0-5. The sum score can range from 0 to 78. Higher scores indicate better function. Least Squares Mean is actually an adjusted mean change from baseline.
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=54 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=50 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=55 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=55 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=101 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Total Score After 12-week Treatment
|
0.10 Unit on scale
Standard Error 0.853
|
-0.99 Unit on scale
Standard Error 0.892
|
0.35 Unit on scale
Standard Error 0.847
|
-1.07 Unit on scale
Standard Error 0.855
|
-0.58 Unit on scale
Standard Error 0.639
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS
The CDR-SB is obtained through semi-structured interviews of patients and informants, and cognitive functioning was rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Each domain was rated on a 5-point scale of functioning as follows: 0-no impairment; 0.5-questionable impairment; 1-mild impairment; 2-moderate impairment and 3-severe impairment. Only personal care was scored on a 4-point scale without a 0.5 rating available. The higher the score, the greater the severity of dementia. Least Squares Mean is actually an adjusted mean change from baseline.
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=54 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=50 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=55 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=55 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=101 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment
|
0.1 Unit on scale
Standard Error 0.23
|
0.3 Unit on scale
Standard Error 0.23
|
0.1 Unit on scale
Standard Error 0.21
|
0.2 Unit on scale
Standard Error 0.22
|
0.1 Unit on scale
Standard Error 0.16
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog11) is an 11-item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 to 70. The greater the dysfunction, the greater the score. Least Squares Mean is actually an adjusted mean change from baseline.
Outcome measures
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=54 Participants
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=50 Participants
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=55 Participants
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=55 Participants
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Pooled BI 409306
n=101 Participants
Patients were administered orally a tablet of BI 409306 (10 mg, 25 mg, 50 mg once daily and 25 mg twice daily)for 12 weeks.
|
Placebo Matching BI 409306
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment
|
1.14 Unit on scale
Standard Error 0.738
|
0.94 Unit on scale
Standard Error 0.776
|
1.11 Unit on scale
Standard Error 0.746
|
2.29 Unit on scale
Standard Error 0.746
|
-0.18 Unit on scale
Standard Error 0.568
|
—
|
Adverse Events
BI 409306 10 Milligram (mg) Once Daily (QD)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
BI 409306 25 mg QD
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 409306 50 mg QD
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 409306 25 mg Twice Daily (BID)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Matching BI 409306
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
Donepezil QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=55 participants at risk
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=53 participants at risk
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=55 participants at risk
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=55 participants at risk
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
n=106 participants at risk
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
Donepezil QD
n=5 participants at risk
Patients were administered orally over capsulated tablet of Donepezil once daily for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.9%
1/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.8%
1/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.8%
1/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.9%
1/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
1.8%
1/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Nervous system disorders
Encephalopathy
|
1.8%
1/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.9%
1/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
3.6%
2/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.8%
1/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
Other adverse events
| Measure |
BI 409306 10 Milligram (mg) Once Daily (QD)
n=55 participants at risk
Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg QD
n=53 participants at risk
Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks.
|
BI 409306 50 mg QD
n=55 participants at risk
Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks.
|
BI 409306 25 mg Twice Daily (BID)
n=55 participants at risk
Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks.
|
Placebo Matching BI 409306
n=106 participants at risk
Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks.
|
Donepezil QD
n=5 participants at risk
Patients were administered orally over capsulated tablet of Donepezil once daily for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
7.5%
4/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
5.5%
3/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.94%
1/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
3/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.8%
1/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.9%
2/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Nervous system disorders
Headache
|
3.6%
2/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
9.4%
5/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.8%
1/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
1.8%
1/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
4.7%
5/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
5.5%
3/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/53 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/55 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
0.00%
0/106 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
20.0%
1/5 • From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
|
Additional Information
Boehringer Ingelheim, Call Centre
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