Trial Outcomes & Findings for Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers (NCT NCT02392468)
NCT ID: NCT02392468
Last Updated: 2024-04-19
Results Overview
The percentage of participants with Adverse Events (AEs), coded to the Medical Dictionary for Regulatory Activities (MedDRA) - System Organ Class (SOC) 'Eye disorders', as determined by the investigator at the End of Trial (EOT) is reported. Percentages were rounded to one decimal place.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
Results posted on
2024-04-19
Participant Flow
The randomised, parallel-group, double-blind study of systemic and ocular safety and pharmacokinetics of BI 409306 in patients with schizophrenia, Alzheimer's disease, and age-comparable healthy volunteers
All participants were screened for eligibility to participate in the trial. Participants attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Participants were not to be entered to trial treatment if any one of the specific entry criteria was violated.
Participant milestones
| Measure |
BI 409306 25 Milligram (mg) - Alzheimer Patients
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Alzheimer Patients
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Schizophrenia Patients
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Schizophrenia Patients
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Healthy Volunteers
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Healthy Volunteers
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
10
|
10
|
9
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
BI 409306 25 Milligram (mg) - Alzheimer Patients
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Alzheimer Patients
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Schizophrenia Patients
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Schizophrenia Patients
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Healthy Volunteers
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Healthy Volunteers
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Treated Set
Baseline characteristics by cohort
| Measure |
BI 409306 25 Milligram (mg) - Alzheimer Patients
n=10 Participants
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Alzheimer Patients
n=11 Participants
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Healthy Volunteers
n=9 Participants
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Healthy Volunteers
n=11 Participants
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
74.5 Years
STANDARD_DEVIATION 9.2 • n=5 Participants • Treated Set
|
77.8 Years
STANDARD_DEVIATION 8.6 • n=7 Participants • Treated Set
|
40.5 Years
STANDARD_DEVIATION 9.1 • n=5 Participants • Treated Set
|
35.1 Years
STANDARD_DEVIATION 7.8 • n=4 Participants • Treated Set
|
55.9 Years
STANDARD_DEVIATION 22.4 • n=21 Participants • Treated Set
|
60.2 Years
STANDARD_DEVIATION 21.6 • n=10 Participants • Treated Set
|
57.7 Years
STANDARD_DEVIATION 21.2 • n=115 Participants • Treated Set
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants • Treated Set
|
8 Participants
n=7 Participants • Treated Set
|
2 Participants
n=5 Participants • Treated Set
|
2 Participants
n=4 Participants • Treated Set
|
4 Participants
n=21 Participants • Treated Set
|
5 Participants
n=10 Participants • Treated Set
|
27 Participants
n=115 Participants • Treated Set
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants • Treated Set
|
3 Participants
n=7 Participants • Treated Set
|
8 Participants
n=5 Participants • Treated Set
|
8 Participants
n=4 Participants • Treated Set
|
5 Participants
n=21 Participants • Treated Set
|
6 Participants
n=10 Participants • Treated Set
|
34 Participants
n=115 Participants • Treated Set
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Treated Set
|
2 Participants
n=7 Participants • Treated Set
|
1 Participants
n=5 Participants • Treated Set
|
1 Participants
n=4 Participants • Treated Set
|
4 Participants
n=21 Participants • Treated Set
|
2 Participants
n=10 Participants • Treated Set
|
10 Participants
n=115 Participants • Treated Set
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants • Treated Set
|
9 Participants
n=7 Participants • Treated Set
|
9 Participants
n=5 Participants • Treated Set
|
9 Participants
n=4 Participants • Treated Set
|
5 Participants
n=21 Participants • Treated Set
|
9 Participants
n=10 Participants • Treated Set
|
51 Participants
n=115 Participants • Treated Set
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
0 Participants
n=115 Participants • Treated Set
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
0 Participants
n=115 Participants • Treated Set
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
1 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
2 Participants
n=115 Participants • Treated Set
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
0 Participants
n=115 Participants • Treated Set
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
6 Participants
n=5 Participants • Treated Set
|
5 Participants
n=4 Participants • Treated Set
|
2 Participants
n=21 Participants • Treated Set
|
2 Participants
n=10 Participants • Treated Set
|
15 Participants
n=115 Participants • Treated Set
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants • Treated Set
|
11 Participants
n=7 Participants • Treated Set
|
3 Participants
n=5 Participants • Treated Set
|
5 Participants
n=4 Participants • Treated Set
|
7 Participants
n=21 Participants • Treated Set
|
9 Participants
n=10 Participants • Treated Set
|
44 Participants
n=115 Participants • Treated Set
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
0 Participants
n=115 Participants • Treated Set
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
0 Participants
n=21 Participants • Treated Set
|
0 Participants
n=10 Participants • Treated Set
|
0 Participants
n=115 Participants • Treated Set
|
PRIMARY outcome
Timeframe: From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.Population: The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
The percentage of participants with Adverse Events (AEs), coded to the Medical Dictionary for Regulatory Activities (MedDRA) - System Organ Class (SOC) 'Eye disorders', as determined by the investigator at the End of Trial (EOT) is reported. Percentages were rounded to one decimal place.
Outcome measures
| Measure |
BI 409306 25 Milligram (mg) - Alzheimer Patients
n=10 Participants
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Alzheimer Patients
n=11 Participants
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Healthy Volunteers
n=9 Participants
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Healthy Volunteers
n=11 Participants
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
|
|---|---|---|---|---|---|---|
|
The Percentage of Participants With Adverse Events (AEs), Coded to the Medical Dictionary for Regulatory Activities - System Organ Class Eye Disorders, as Determined by the Investigator at the End of Trial
|
40.0 Percentage of participants
|
27.3 Percentage of participants
|
0.0 Percentage of participants
|
20.0 Percentage of participants
|
22.2 Percentage of participants
|
72.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.Population: The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
The percentage of participants with drug-related adverse events (AEs) as determined by the investigator at end of trial (EOT) is reported. Percentages were rounded to one decimal place.
Outcome measures
| Measure |
BI 409306 25 Milligram (mg) - Alzheimer Patients
n=10 Participants
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Alzheimer Patients
n=11 Participants
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Healthy Volunteers
n=9 Participants
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Healthy Volunteers
n=11 Participants
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
|
|---|---|---|---|---|---|---|
|
The Percentage of Participants With Drug-related AEs as Determined by the Investigator at EOT
|
30.0 Percentage of participants
|
36.4 Percentage of participants
|
0.0 Percentage of participants
|
20.0 Percentage of participants
|
33.3 Percentage of participants
|
81.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.Population: The Pharmacokinetic (PK) set (PKS) included all participants in the TS who provided at least 1 evaluable observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK. Only participants with evaluable results for this PK parameter are reported.
Maximum measured concentration of BI 409306 in plasma at steady-state (Cmax,ss) is reported.
Outcome measures
| Measure |
BI 409306 25 Milligram (mg) - Alzheimer Patients
n=10 Participants
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Alzheimer Patients
n=10 Participants
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Healthy Volunteers
n=9 Participants
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Healthy Volunteers
n=10 Participants
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)
|
696 nanomoles per litre (nmol/L)
Geometric Coefficient of Variation 86.6
|
2290 nanomoles per litre (nmol/L)
Geometric Coefficient of Variation 115.0
|
202 nanomoles per litre (nmol/L)
Geometric Coefficient of Variation 72.1
|
1050 nanomoles per litre (nmol/L)
Geometric Coefficient of Variation 60.4
|
466 nanomoles per litre (nmol/L)
Geometric Coefficient of Variation 37.5
|
1550 nanomoles per litre (nmol/L)
Geometric Coefficient of Variation 153.0
|
SECONDARY outcome
Timeframe: Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.Population: The Pharmacokinetic (PK) set (PKS) included all participants in the TS who provided at least 1 evaluable observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK. Only participants with evaluable results for this PK parameter are reported.
Time from dosing to maximum measured concentration of BI 409306 in plasma at steady-state (tmax,ss) is reported.
Outcome measures
| Measure |
BI 409306 25 Milligram (mg) - Alzheimer Patients
n=10 Participants
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Alzheimer Patients
n=10 Participants
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Schizophrenia Patients
n=10 Participants
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Healthy Volunteers
n=9 Participants
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Healthy Volunteers
n=10 Participants
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
|
|---|---|---|---|---|---|---|
|
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)
|
0.750 Hours
Interval 0.5 to 2.0
|
1.000 Hours
Interval 0.333 to 4.0
|
0.500 Hours
Interval 0.333 to 1.5
|
0.525 Hours
Interval 0.333 to 1.5
|
0.500 Hours
Interval 0.333 to 4.0
|
0.917 Hours
Interval 0.333 to 4.0
|
Adverse Events
BI 409306 25 Milligram (mg) - Alzheimer Patients
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 409306 100 mg - Alzheimer Patients
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 409306 25 mg - Schizophrenia Patients
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 409306 100 mg - Schizophrenia Patients
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 409306 25 mg - Healthy Volunteers
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 409306 100 mg - Healthy Volunteers
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 409306 25 Milligram (mg) - Alzheimer Patients
n=10 participants at risk
Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Alzheimer Patients
n=11 participants at risk
Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Schizophrenia Patients
n=10 participants at risk
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Schizophrenia Patients
n=10 participants at risk
Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days.
|
BI 409306 25 mg - Healthy Volunteers
n=9 participants at risk
Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days.
|
BI 409306 100 mg - Healthy Volunteers
n=11 participants at risk
Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Chromatopsia
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
36.4%
4/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Cyanopsia
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Photophobia
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Photopsia
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
27.3%
3/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Visual brightness
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
22.2%
2/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
27.3%
3/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Visual impairment
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Xanthopsia
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
20.0%
2/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
22.2%
2/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
22.2%
2/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
General disorders
Fatigue
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
22.2%
2/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
20.0%
2/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
18.2%
2/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Cardiac disorders
Cyanosis
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Asthenopia
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Chloropsia
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Dyschromatopsia
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Eye disorder
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Eye irritation
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Eye pruritus
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Eye disorders
Ocular hyperaemia
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Splinter
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Investigations
Blood glucose increased
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Investigations
Heart rate increased
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Investigations
Heart rate irregular
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Tension headache
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Psychiatric disorders
Hallucination, visual
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
10.0%
1/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
9.1%
1/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/10 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
11.1%
1/9 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
0.00%
0/11 • From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The residual effect period (REP) was defined as 7 days after the last trial medication intake. All adverse events which occurred through the treatment phase and throughout the REP were considered as on treatment. The treated set (TS) included all participants who were documented to have been administered at least 1 dose of investigational treatment.
|
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