Trial Outcomes & Findings for Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia (NCT NCT02832037)
NCT ID: NCT02832037
Last Updated: 2021-02-24
Results Overview
MCCB overall composite T-score was derived from scores of 7 cognitive domains (Speed of Processing, Verbal Learning, Working Memory, Reasoning and Problem Solving, Visual Learning, Social Cognition, Attention) obtained from a total of 10 tests (Trail Making, Brief Assessment of Cognition in Schizophrenia, Hopkins Verbal Learning, Wechsler Memory Scale, Letter-Number Span, Neuropsychological Assessment Battery, Brief Visuospatial Memory, Category Fluency, Mayer-Salovey-Caruso Emotional Intelligence, Continuous Performance) and ranges typically between -20 and +99, a larger T-score indicates better cognition. Change from baseline in MCCB overall composite T-score after 12 weeks of treatment was modeled using a MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (week 6 and week 12 of treatment) as repeated measures, subject as random effect, adjusted mean (standard error) after 12 weeks of treatment is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
509 participants
Primary outcome timeframe
Baseline, after 6 and 12 weeks of treatment
Results posted on
2021-02-24
Participant Flow
This was a phase II randomized, double-blind, double-dummy, placebo-controlled, multi-center, multi-national, 12-week parallel-group trial in participants with schizophrenia. Abbreviation: MMRM=Mixed-effects Model Repeated Measures
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 |
BI 425809 2 mg Once a Day (q.d.)
2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 5 mg q.d.
5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 10 mg q.d.
10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 25 mg q.d.
25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
Placebo q.d.
Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
85
|
84
|
85
|
85
|
170
|
|
Overall Study
COMPLETED
|
66
|
72
|
77
|
78
|
151
|
|
Overall Study
NOT COMPLETED
|
19
|
12
|
8
|
7
|
19
|
Reasons for withdrawal
| Measure |
BI 425809 2 mg Once a Day (q.d.)
2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 5 mg q.d.
5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 10 mg q.d.
10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 25 mg q.d.
25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
Placebo q.d.
Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
|---|---|---|---|---|---|
|
Overall Study
Administrative reasons
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
4
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
3
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
0
|
4
|
8
|
|
Overall Study
Adverse Event
|
5
|
4
|
0
|
2
|
4
|
Baseline Characteristics
Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia
Baseline characteristics by cohort
| Measure |
BI 425809 2 mg Once a Day (q.d.)
n=85 Participants
2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 5 mg q.d.
n=84 Participants
5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 10 mg q.d.
n=85 Participants
10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 25 mg q.d.
n=85 Participants
25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
Placebo q.d.
n=170 Participants
Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
Total
n=509 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
37.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
37.2 years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
37.1 years
STANDARD_DEVIATION 7.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
180 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
329 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
468 Participants
n=10 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=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
145 Participants
n=10 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
119 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
237 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=10 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=10 Participants
|
|
MATRICS Consensus Cognitive Battery (MCCB) overall composite T-score
|
30.0 Score on a scale
STANDARD_DEVIATION 13.8 • n=5 Participants
|
32.8 Score on a scale
STANDARD_DEVIATION 12.0 • n=7 Participants
|
31.8 Score on a scale
STANDARD_DEVIATION 12.8 • n=5 Participants
|
30.2 Score on a scale
STANDARD_DEVIATION 13.2 • n=4 Participants
|
32.3 Score on a scale
STANDARD_DEVIATION 13.6 • n=21 Participants
|
31.5 Score on a scale
STANDARD_DEVIATION 13.2 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, after 6 and 12 weeks of treatmentPopulation: The Full Analysis Set included all participants who were randomized and were treated with at least 1 dose of trial medication and who had a non-missing baseline measurement and at least 1 non-missing post-baseline and on-treatment measurement for the primary or secondary efficacy endpoint.
MCCB overall composite T-score was derived from scores of 7 cognitive domains (Speed of Processing, Verbal Learning, Working Memory, Reasoning and Problem Solving, Visual Learning, Social Cognition, Attention) obtained from a total of 10 tests (Trail Making, Brief Assessment of Cognition in Schizophrenia, Hopkins Verbal Learning, Wechsler Memory Scale, Letter-Number Span, Neuropsychological Assessment Battery, Brief Visuospatial Memory, Category Fluency, Mayer-Salovey-Caruso Emotional Intelligence, Continuous Performance) and ranges typically between -20 and +99, a larger T-score indicates better cognition. Change from baseline in MCCB overall composite T-score after 12 weeks of treatment was modeled using a MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (week 6 and week 12 of treatment) as repeated measures, subject as random effect, adjusted mean (standard error) after 12 weeks of treatment is reported.
Outcome measures
| Measure |
BI 425809 2 mg Once a Day (q.d.)
n=79 Participants
2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 5 mg q.d.
n=80 Participants
5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 10 mg q.d.
n=82 Participants
10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 25 mg q.d.
n=83 Participants
25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
Placebo q.d.
n=163 Participants
Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
|---|---|---|---|---|---|
|
Change From Baseline in Cognitive Function as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Overall Composite T-score After 12 Weeks of Treatment
|
1.784 scores on a scale
Standard Error 0.6805
|
1.641 scores on a scale
Standard Error 0.6656
|
3.486 scores on a scale
Standard Error 0.6410
|
3.234 scores on a scale
Standard Error 0.6410
|
1.504 scores on a scale
Standard Error 0.4579
|
SECONDARY outcome
Timeframe: Baseline and after 12 weeks of treatmentPopulation: The Full Analysis Set included all participants who were randomized and were treated with at least 1 dose of trial medication and who had a non-missing baseline measurement and at least 1 non-missing post-baseline and on-treatment measurement for the primary or secondary efficacy endpoint.
SCoRS total score was derived as the sum of non-missing responses from 20 interview-based items rated by an interviewer on a 4-point scale. A response of "not available" to an item was treated as missing. If six or more of the 20 items were missing for a participant at a visit, then the corresponding SCoRS total score was missing for that participant at the visit. If five or less of the 20 items were missing for a participant at a visit, then the item(s) with missing value(s) were imputed first with the average of the non-missing item values, then the SCoRS total score for the participant at the visit was derived as the sum of non-missing item values and the imputed item values. SCoRS total score is between 20 and 80 where higher score values represent greater degree of impairment in day-to-day functions due to cognitive deficits. Analysis of covariance model was fitted to calculate adjusted mean and standard error, model details in the Statistical Analysis section.
Outcome measures
| Measure |
BI 425809 2 mg Once a Day (q.d.)
n=77 Participants
2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 5 mg q.d.
n=80 Participants
5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 10 mg q.d.
n=82 Participants
10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 25 mg q.d.
n=83 Participants
25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
Placebo q.d.
n=158 Participants
Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
|---|---|---|---|---|---|
|
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 12 Weeks of Treatment
|
-1.637 units on a scale
Standard Error 0.5992
|
-3.652 units on a scale
Standard Error 0.5890
|
-3.078 units on a scale
Standard Error 0.5803
|
-3.887 units on a scale
Standard Error 0.5770
|
-2.815 units on a scale
Standard Error 0.4181
|
SECONDARY outcome
Timeframe: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 daysPopulation: The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
Percentage of participants with any Adverse Event.
Outcome measures
| Measure |
BI 425809 2 mg Once a Day (q.d.)
n=85 Participants
2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 5 mg q.d.
n=84 Participants
5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 10 mg q.d.
n=85 Participants
10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 25 mg q.d.
n=85 Participants
25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
Placebo q.d.
n=170 Participants
Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Any Adverse Event
|
58.8 Percentage of participants
|
52.4 Percentage of participants
|
41.2 Percentage of participants
|
42.4 Percentage of participants
|
43.5 Percentage of participants
|
Adverse Events
BI 425809 2 mg Once a Day (q.d.)
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
BI 425809 5 mg q.d.
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
BI 425809 10 mg q.d.
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
BI 425809 25 mg q.d.
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo q.d.
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 425809 2 mg Once a Day (q.d.)
n=85 participants at risk
2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 5 mg q.d.
n=84 participants at risk
5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 10 mg q.d.
n=85 participants at risk
10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 25 mg q.d.
n=85 participants at risk
25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
Placebo q.d.
n=170 participants at risk
Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
|---|---|---|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Infections and infestations
Infective myositis
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.59%
1/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.59%
1/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Psychiatric disorders
Fear of disease
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Psychiatric disorders
Psychotic symptom
|
1.2%
1/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Psychiatric disorders
Schizophrenia
|
1.2%
1/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.59%
1/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.59%
1/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
0.00%
0/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.2%
1/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
1.8%
3/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
Other adverse events
| Measure |
BI 425809 2 mg Once a Day (q.d.)
n=85 participants at risk
2 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 1 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 5 mg q.d.
n=84 participants at risk
5 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 5 mg BI 425809, 1 placebo tablet matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 10 mg q.d.
n=85 participants at risk
10 milligram (mg) of BI 425809 administered orally (2 tablets with tablet strength 5 mg BI 425809, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food in the morning, once daily. Continuous daily dosing for 12 weeks (planned treatment duration).
|
BI 425809 25 mg q.d.
n=85 participants at risk
25 milligram (mg) of BI 425809 administered orally (1 tablet with tablet strength 25 mg BI 425809, 2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
Placebo q.d.
n=170 participants at risk
Placebo administered orally (2 placebo tablets matching 1 mg and 5 mg BI 425809 tablets, 1 placebo tablet matching 25 mg BI 425809 tablets) with water, with or without food, once daily in the morning. Continuous daily dosing for 12 weeks (planned treatment duration).
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.4%
8/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
10.7%
9/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
8.2%
7/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
4.7%
4/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
7.6%
13/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Nervous system disorders
Dizziness
|
5.9%
5/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
4.8%
4/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
2.4%
2/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
3.5%
3/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
3.5%
6/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Nervous system disorders
Headache
|
9.4%
8/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
11.9%
10/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
8.2%
7/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
9.4%
8/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
5.3%
9/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
|
Nervous system disorders
Somnolence
|
2.4%
2/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
6.0%
5/84 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
5.9%
5/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
2.4%
2/85 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
2.4%
4/170 • For Serious and Other Adverse Events: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days. For All-Cause Mortality: On-treatment period + Follow-up period (planned: 28±7 days), up to 127 days.
The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
|
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