Trial Outcomes & Findings for Safety and Tolerability of BI 409306 in Patients With Schizophrenia (NCT NCT01892384)
NCT ID: NCT01892384
Last Updated: 2024-04-25
Results Overview
Number of participants with drug-related adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
From first drug administration until 30 days after last drug administration, up to 44 days.
Results posted on
2024-04-25
Participant Flow
This was a randomized, double-blind, parallel-group, placebo-controlled trial in patients with mild-to-moderate schizophrenia. Patients were enrolled in the study once informed consent had been obtained. Patients who subsequently met all eligibility criteria at screening were randomized in a 1:1:1:1 ratio to one of four treatment groups.
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 409306 25mg
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
Patients received placebo, administered orally, once daily for 14 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
BI 409306 25mg
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
Patients received placebo, administered orally, once daily for 14 days
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Tolerability of BI 409306 in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
BI 409306 25mg
n=10 Participants
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
n=10 Participants
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
n=10 Participants
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
n=10 Participants
Patients received placebo, administered orally, once daily for 14 days
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.9 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
42.5 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
42.5 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
37.8 Years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
40.2 Years
STANDARD_DEVIATION 9.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 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
|
|
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
|
PRIMARY outcome
Timeframe: From first drug administration until 30 days after last drug administration, up to 44 days.Population: Treated set which included all randomized patients who received at least one dose of study medication.
Number of participants with drug-related adverse events.
Outcome measures
| Measure |
BI 409306 25mg
n=10 Participants
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
n=10 Participants
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
n=10 Participants
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
n=10 Participants
Patients received placebo, administered orally, once daily for 14 days
|
|---|---|---|---|---|
|
Number of Participants With Drug-related Adverse Events
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administrationPopulation: Pharmacokinetic (PK) set which included all participants who received at least one dose of BI 409306 and had no important protocol violations relevant to the evaluation of PK and provided at least one evaluable observation for a PK endpoint.
Maximum measured concentration of BI 409306 in plasma after single dose (Cmax) is presented.
Outcome measures
| Measure |
BI 409306 25mg
n=10 Participants
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
n=10 Participants
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
n=10 Participants
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
Patients received placebo, administered orally, once daily for 14 days
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Cmax)
|
138 nanomole/Litre (nmol/L)
Geometric Coefficient of Variation 91.9
|
431 nanomole/Litre (nmol/L)
Geometric Coefficient of Variation 73.3
|
998 nanomole/Litre (nmol/L)
Geometric Coefficient of Variation 106.0
|
—
|
SECONDARY outcome
Timeframe: 2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.Population: Pharmacokinetic (PK) set which included all participants who received at least one dose of BI 409306 and had no important protocol violations relevant to the evaluation of PK and provided at least one evaluable observation for a PK endpoint. Two patients were discontinued from treatment after 6 days (25 mg group) or 5 days (50 mg group) after withdrawing consent.
Maximum measured concentration of BI 409306 in plasma at steady-state (Cmax,ss) is presented.
Outcome measures
| Measure |
BI 409306 25mg
n=9 Participants
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
n=9 Participants
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
n=10 Participants
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
Patients received placebo, administered orally, once daily for 14 days
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)
|
99.2 nanomole/Litre (nmol/L)
Geometric Coefficient of Variation 86.8
|
631 nanomole/Litre (nmol/L)
Geometric Coefficient of Variation 90.9
|
1290 nanomole/Litre (nmol/L)
Geometric Coefficient of Variation 74.4
|
—
|
SECONDARY outcome
Timeframe: 2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.Population: Pharmacokinetic (PK) set which included all participants who received at least one dose of BI 409306 and had no important protocol violations relevant to the evaluation of PK and provided at least one evaluable observation for a PK endpoint.
Time from dosing to maximum measured concentration of BI 409306 in plasma after single dose (tmax) is presented.
Outcome measures
| Measure |
BI 409306 25mg
n=10 Participants
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
n=10 Participants
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
n=10 Participants
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
Patients received placebo, administered orally, once daily for 14 days
|
|---|---|---|---|---|
|
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Tmax)
|
0.625 Hours
Interval 0.33 to 1.5
|
0.625 Hours
Interval 0.33 to 2.0
|
0.750 Hours
Interval 0.33 to 2.0
|
—
|
SECONDARY outcome
Timeframe: 2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.Population: Pharmacokinetic (PK) set which included all participants who received at least one dose of BI 409306 and had no important protocol violations relevant to the evaluation of PK and provided at least one evaluable observation for a PK endpoint. Two patients were discontinued from treatment after 6 days (25 mg group) or 5 days (50 mg group) after withdrawing consent.
Time from dosing to maximum measured concentration of BI 409306 in plasma at steady-state (tmax,ss) is presented.
Outcome measures
| Measure |
BI 409306 25mg
n=9 Participants
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
n=9 Participants
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
n=10 Participants
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
Patients received placebo, administered orally, once daily for 14 days
|
|---|---|---|---|---|
|
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)
|
0.750 Hours
Interval 0.33 to 1.0
|
0.333 Hours
Interval 0.33 to 1.5
|
0.625 Hours
Interval 0.33 to 1.5
|
—
|
SECONDARY outcome
Timeframe: 2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.Population: Pharmacokinetic (PK) set which included all participants who received at least one dose of BI 409306 and had no important protocol violations relevant to the evaluation of PK and provided at least one evaluable observation for a PK endpoint.
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity after a single dose (AUC0-infinity) is presented.
Outcome measures
| Measure |
BI 409306 25mg
n=10 Participants
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
n=10 Participants
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
n=10 Participants
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
Patients received placebo, administered orally, once daily for 14 days
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After a Single Dose (AUC0-infinity)
|
217 nanomole*hour/Litre (nmol*h/L)
Geometric Coefficient of Variation 107.0
|
770 nanomole*hour/Litre (nmol*h/L)
Geometric Coefficient of Variation 98.4
|
2020 nanomole*hour/Litre (nmol*h/L)
Geometric Coefficient of Variation 108.0
|
—
|
SECONDARY outcome
Timeframe: 2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.Population: Pharmacokinetic (PK) set which included all participants who received at least one dose of BI 409306 and had no important protocol violations relevant to the evaluation of PK and provided at least one evaluable observation for a PK endpoint. Two patients were discontinued from treatment after 6 days (25 mg group) or 5 days (50 mg group) after withdrawing consent.
Area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval tau (AUCtau,ss) is presented.
Outcome measures
| Measure |
BI 409306 25mg
n=9 Participants
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
n=9 Participants
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
n=10 Participants
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
Patients received placebo, administered orally, once daily for 14 days
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss)
|
147 nanomole*hour/Litre (nmol*h/L)
Geometric Coefficient of Variation 112.0
|
969 nanomole*hour/Litre (nmol*h/L)
Geometric Coefficient of Variation 104.0
|
2280 nanomole*hour/Litre (nmol*h/L)
Geometric Coefficient of Variation 86.8
|
—
|
Adverse Events
BI 409306 25mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 409306 50mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 409306 100mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Total.
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 409306 25mg
n=10 participants at risk
Patients received BI 409306 25mg (low dose), administered orally, once daily for 14 days
|
BI 409306 50mg
n=10 participants at risk
Patients received BI 409306 50mg (medium dose), administered orally, once daily for 14 days
|
BI 409306 100mg
n=10 participants at risk
Patients received BI 409306 100mg (high dose), administered orally, once daily for 14 days
|
Placebo
n=10 participants at risk
Patients received placebo, administered orally, once daily for 14 days
|
Total.
n=40 participants at risk
All patients entered into the study received either BI 409306 or placebo once daily for 14 days.
|
|---|---|---|---|---|---|
|
Eye disorders
Photopsia
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
5.0%
2/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Eye disorders
Vision blurred
|
20.0%
2/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
30.0%
3/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
20.0%
2/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
20.0%
8/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Eye disorders
Visual impairment
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
5.0%
2/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
General disorders
Pre-existing condition improved
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Infections and infestations
Furuncle
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
5.0%
2/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
20.0%
2/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
5.0%
2/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
5.0%
2/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
2.5%
1/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
5.0%
2/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
10.0%
1/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
0.00%
0/10 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study medication.
|
5.0%
2/40 • From first dose of study medication until 30 days after the last dose of study medication, up to 44 days.
Treated set which included all randomized patients who received at least one dose of study 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