Trial Outcomes & Findings for Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers (NCT NCT02525679)
NCT ID: NCT02525679
Last Updated: 2024-03-15
Results Overview
Percentage of subjects with drug related adverse events are presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
78 participants
Primary outcome timeframe
Adverse events reported until the end-of-trial examination; up to day 74
Results posted on
2024-03-15
Participant Flow
A total of 78 subjects were randomised to 11 sequential dose groups (including an unplanned dose group). All subjects completed the trial according to the protocol. 3 subjects were not dosed as planned: they received 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130.
A total of 80 subjects were planned to be included in 10 sequential dose groups, each consisting of 8 subjects (6 on BI 655130 and 2 on placebo). However, 1 additional dose group was introduced to accommodate for a dosing error administration of 0.050 mg/kg instead of 0.100 mg/kg;
Participant milestones
| Measure |
0.001 mg/kg BI 655130 (Dose Group 1)
Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion
|
0.003 mg/kg BI 655130 (Dose Group 2)
Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.010 mg/kg BI 655130 (Dose Group 3)
Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.030 mg/kg BI 655130 (Dose Group 4)
Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.100 mg/kg BI 655130 (Dose Group 5)
Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.300 mg/kg BI 655130 (Dose Group 6)
Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
1 mg/kg BI 655130 (Dose Group 7)
Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
3 mg/kg BI 655130 (Dose Group 8)
Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
6 mg/kg BI 655130 (Dose Group 9)
Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
10 mg/kg BI 655130 (Dose Group 10)
Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.050 mg/kg BI 655130 (Unplanned)
Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130
|
Placebo
Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
5
|
4
|
6
|
6
|
6
|
4
|
3
|
20
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
5
|
4
|
6
|
6
|
6
|
4
|
3
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
0.001 mg/kg BI 655130 (Dose Group 1)
n=6 Participants
Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion
|
0.003 mg/kg BI 655130 (Dose Group 2)
n=6 Participants
Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.010 mg/kg BI 655130 (Dose Group 3)
n=6 Participants
Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.030 mg/kg BI 655130 (Dose Group 4)
n=6 Participants
Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.100 mg/kg BI 655130 (Dose Group 5)
n=5 Participants
Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.300 mg/kg BI 655130 (Dose Group 6)
n=4 Participants
Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
1 mg/kg BI 655130 (Dose Group 7)
n=6 Participants
Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
3 mg/kg BI 655130 (Dose Group 8)
n=6 Participants
Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
6 mg/kg BI 655130 (Dose Group 9)
n=6 Participants
Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
10 mg/kg BI 655130 (Dose Group 10)
n=4 Participants
Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.050 mg/kg BI 655130 (Unplanned)
n=3 Participants
Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130
|
Placebo
n=20 Participants
Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.5 years
STANDARD_DEVIATION 5.0 • n=99 Participants
|
33.2 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
33.2 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
31.2 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 2.5 • n=31 Participants
|
33.5 years
STANDARD_DEVIATION 2.6 • n=30 Participants
|
32.5 years
STANDARD_DEVIATION 7.7 • n=3 Participants
|
34.2 years
STANDARD_DEVIATION 6.5 • n=6 Participants
|
36.0 years
STANDARD_DEVIATION 9.9 • n=114 Participants
|
29.8 years
STANDARD_DEVIATION 5.6
|
31.0 years
STANDARD_DEVIATION 7.0 • n=19 Participants
|
34.2 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
33.1 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
4 Participants
|
3 Participants
n=19 Participants
|
20 Participants
n=4 Participants
|
78 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
4 Participants
|
3 Participants
n=19 Participants
|
20 Participants
n=4 Participants
|
77 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
4 Participants
|
3 Participants
n=19 Participants
|
19 Participants
n=4 Participants
|
76 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
00 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Adverse events reported until the end-of-trial examination; up to day 74Population: Treated set
Percentage of subjects with drug related adverse events are presented.
Outcome measures
| Measure |
0.001 mg/kg BI 655130 (Dose Group 1)
n=6 Participants
Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion
|
0.003 mg/kg BI 655130 (Dose Group 2)
n=6 Participants
Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.010 mg/kg BI 655130 (Dose Group 3)
n=6 Participants
Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.030 mg/kg BI 655130 (Dose Group 4)
n=6 Participants
Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.100 mg/kg BI 655130 (Dose Group 5)
n=5 Participants
Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.300 mg/kg BI 655130 (Dose Group 6)
n=4 Participants
Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
1 mg/kg BI 655130 (Dose Group 7)
n=6 Participants
Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
3 mg/kg BI 655130 (Dose Group 8)
n=6 Participants
Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
6 mg/kg BI 655130 (Dose Group 9)
n=6 Participants
Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
10 mg/kg BI 655130 (Dose Group 10)
n=4 Participants
Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.050 mg/kg BI 655130 (Unplanned)
n=3 Participants
Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130
|
Placebo
n=20 Participants
Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Drug Related Adverse Events
|
16.7 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
15.0 percentage of participants
|
SECONDARY outcome
Timeframe: -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administrationPopulation: Descriptive pharmacokinetic analysis set (PKSD): The descriptive analysis of PK (pharmacokinetic) concentrations and parameters was based on all treated subjects who provided at least 1 PK concentration (plasma or urine) that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.
Maximum measured concentration of BI 655130 in plasma (Cmax) is presented.
Outcome measures
| Measure |
0.001 mg/kg BI 655130 (Dose Group 1)
n=6 Participants
Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion
|
0.003 mg/kg BI 655130 (Dose Group 2)
n=6 Participants
Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.010 mg/kg BI 655130 (Dose Group 3)
n=4 Participants
Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.030 mg/kg BI 655130 (Dose Group 4)
n=6 Participants
Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.100 mg/kg BI 655130 (Dose Group 5)
n=5 Participants
Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.300 mg/kg BI 655130 (Dose Group 6)
n=4 Participants
Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
1 mg/kg BI 655130 (Dose Group 7)
n=6 Participants
Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
3 mg/kg BI 655130 (Dose Group 8)
n=6 Participants
Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
6 mg/kg BI 655130 (Dose Group 9)
n=6 Participants
Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
10 mg/kg BI 655130 (Dose Group 10)
n=4 Participants
Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.050 mg/kg BI 655130 (Unplanned)
n=3 Participants
Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130
|
Placebo
Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)
|
NA micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation NA
Not available as plasma concentrations were below lower limit of quantification (BLQ)
|
NA micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation NA
Not available as plasma concentrations were below lower limit of quantification (BLQ)
|
0.0228 micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation 33.5
|
0.413 micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation 21.2
|
1.96 micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation 11.9
|
6.63 micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation 3.28
|
20.3 micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation 13.6
|
60.6 micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation 7.17
|
153 micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation 12.7
|
235 micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation 2.79
|
0.998 micrograms/milliLitres (μg/mL)
Geometric Coefficient of Variation 15.7
|
—
|
SECONDARY outcome
Timeframe: -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administrationPopulation: Descriptive pharmacokinetic analysis set (PKSD): The descriptive analysis of PK (pharmacokinetic) concentrations and parameters was based on all treated subjects who provided at least 1 PK concentration (plasma or urine) that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.
Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented. Reliable values of AUC0-∞ could not be calculated because concentrations were too high at the last PK sample collected "1680h" after drug administration. AUC0-tz was utilized for the dose proportionality analyses instead of AUC0-∞.
Outcome measures
| Measure |
0.001 mg/kg BI 655130 (Dose Group 1)
n=6 Participants
Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion
|
0.003 mg/kg BI 655130 (Dose Group 2)
n=6 Participants
Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.010 mg/kg BI 655130 (Dose Group 3)
n=4 Participants
Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.030 mg/kg BI 655130 (Dose Group 4)
n=6 Participants
Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.100 mg/kg BI 655130 (Dose Group 5)
n=5 Participants
Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.300 mg/kg BI 655130 (Dose Group 6)
n=4 Participants
Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
1 mg/kg BI 655130 (Dose Group 7)
n=6 Participants
Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
3 mg/kg BI 655130 (Dose Group 8)
n=6 Participants
Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
6 mg/kg BI 655130 (Dose Group 9)
n=6 Participants
Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
10 mg/kg BI 655130 (Dose Group 10)
n=4 Participants
Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.050 mg/kg BI 655130 (Unplanned)
n=3 Participants
Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130
|
Placebo
Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
NA micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation NA
Not available as plasma concentrations were below lower limit of quantification (BLQ)
|
NA micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation NA
Not available as plasma concentrations were below lower limit of quantification (BLQ)
|
0.0234 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 125
|
2.35 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 23.9
|
27.7 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 16.6
|
127 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 6.05
|
563 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 26.2
|
1260 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 6.81
|
3380 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 15.6
|
5080 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 18.9
|
13.0 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 6.59
|
—
|
SECONDARY outcome
Timeframe: -2 hours (h) before and 0.5h, 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h after drug administrationPopulation: Descriptive pharmacokinetic analysis set (PKSD): The descriptive analysis of PK (pharmacokinetic) concentrations and parameters was based on all treated subjects who provided at least 1 PK concentration (plasma or urine) that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.
Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 to the last measurable plasma concentration (AUC0-tz) is presented.
Outcome measures
| Measure |
0.001 mg/kg BI 655130 (Dose Group 1)
n=6 Participants
Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion
|
0.003 mg/kg BI 655130 (Dose Group 2)
n=6 Participants
Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.010 mg/kg BI 655130 (Dose Group 3)
n=4 Participants
Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.030 mg/kg BI 655130 (Dose Group 4)
n=6 Participants
Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.100 mg/kg BI 655130 (Dose Group 5)
n=5 Participants
Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.300 mg/kg BI 655130 (Dose Group 6)
n=4 Participants
Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
1 mg/kg BI 655130 (Dose Group 7)
n=6 Participants
Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
3 mg/kg BI 655130 (Dose Group 8)
n=6 Participants
Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
6 mg/kg BI 655130 (Dose Group 9)
n=6 Participants
Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
10 mg/kg BI 655130 (Dose Group 10)
n=4 Participants
Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.050 mg/kg BI 655130 (Unplanned)
n=3 Participants
Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130
|
Placebo
Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 to the Last Measurable Plasma Concentration (AUC0-tz)
|
NA micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation NA
Not available as plasma concentrations were below lower limit of quantification (BLQ)
|
NA micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation NA
Not available as plasma concentrations were below lower limit of quantification (BLQ)
|
0.00652 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 121
|
2.08 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 29.0
|
25.1 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 15.5
|
113 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 5.86
|
420 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 13.3
|
1050 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 7.26
|
2610 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 11.7
|
4130 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 12.1
|
9.57 micrograms*day/milliLitres (μg*day/mL)
Geometric Coefficient of Variation 5.90
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
0.001 mg/kg BI 655130 (Dose Group 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.003 mg/kg BI 655130 (Dose Group 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.010 mg/kg BI 655130 (Dose Group 3)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.030 mg/kg BI 655130 (Dose Group 4)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.100 mg/kg BI 655130 (Dose Group 5)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.300 mg/kg BI 655130 (Dose Group 6)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1 mg/kg BI 655130 (Dose Group 7)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
3 mg/kg BI 655130 (Dose Group 8)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
6 mg/kg BI 655130 (Dose Group 9)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
10 mg/kg BI 655130 (Dose Group 10)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.050 mg/kg BI 655130 (Unplanned)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Male healthy volunteers received single dose of matching placebo as concentrate for solution for IV 30 min infusion.
|
0.001 mg/kg BI 655130 (Dose Group 1)
n=6 participants at risk
Male healthy volunteers received single dose of 0.001 milligrams/kilograms (mg/kg) BI 655130 as concentrate for solution for Intravenous (IV) 30 min infusion
|
0.003 mg/kg BI 655130 (Dose Group 2)
n=6 participants at risk
Male healthy volunteers received single dose of 0.003 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.010 mg/kg BI 655130 (Dose Group 3)
n=6 participants at risk
Male healthy volunteers received single dose of 0.010 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.030 mg/kg BI 655130 (Dose Group 4)
n=6 participants at risk
Male healthy volunteers received single dose of 0.030 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.100 mg/kg BI 655130 (Dose Group 5)
n=5 participants at risk
Male healthy volunteers received single dose of 0.100 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.300 mg/kg BI 655130 (Dose Group 6)
n=4 participants at risk
Male healthy volunteers received single dose of0.300 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
1 mg/kg BI 655130 (Dose Group 7)
n=6 participants at risk
Male healthy volunteers received single dose of 1 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
3 mg/kg BI 655130 (Dose Group 8)
n=6 participants at risk
Male healthy volunteers received single dose of 3 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
6 mg/kg BI 655130 (Dose Group 9)
n=6 participants at risk
Male healthy volunteers received single dose of 6 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
10 mg/kg BI 655130 (Dose Group 10)
n=4 participants at risk
Male healthy volunteers received single dose of 10 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion
|
0.050 mg/kg BI 655130 (Unplanned)
n=3 participants at risk
Male healthy volunteers received single dose of 0.050 mg/kg BI 655130 as concentrate for solution for IV 30 min infusion (unit strength: 20 milligrams/milliLitres (mg/mL). This separate group (unplanned) was introduced to accommodate subjects who had been wrongly administered 0.050 mg/kg BI 655130 instead of the planned 0.100 mg/kg BI 655130
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
20.0%
1/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
25.0%
1/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
25.0%
1/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
33.3%
1/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
General disorders
Fatigue
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
General disorders
Influenza like illness
|
10.0%
2/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
33.3%
2/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
General disorders
Injection site haematoma
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
20.0%
1/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
General disorders
Injection site reaction
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
25.0%
1/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
66.7%
4/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
40.0%
2/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
33.3%
2/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
33.3%
1/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
33.3%
2/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
25.0%
1/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
33.3%
2/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
25.0%
1/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.0%
1/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/20 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/5 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
16.7%
1/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/6 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/4 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
0.00%
0/3 • Adverse events reported until the end-of-trial examination; up to day 74.
Treated set (TS): The TS included all subjects from the randomised set who were documented to have taken at least 1 dose of trial medication. All 78 randomised subjects were included in the TS.
|
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