Trial Outcomes & Findings for A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation (NCT NCT01917006)
NCT ID: NCT01917006
Last Updated: 2018-10-18
Results Overview
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Baseline (Day 1) to Week 12
Results posted on
2018-10-18
Participant Flow
Participants received a single treatment of either placebo or OnabotulinumtoxinA (Doses 1, 2, 3, 4, 5, 6), delivered bilaterally to the bulbospongiosus muscle in randomized-treatment period. Participants who completed 12 weeks of randomized period were eligible to receive second injection with OnabotulinumtoxinA Dose 2 in Open-label Period.
Participant milestones
| Measure |
OnabotulinumtoxinA Dose 1
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
|
OnabotulinumtoxinA Dose 3
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 4
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 5
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 6
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
|
Placebo
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2 (Open-label Period)
Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.
|
|---|---|---|---|---|---|---|---|---|
|
Randomized-treatment Period
STARTED
|
5
|
7
|
8
|
8
|
8
|
8
|
15
|
0
|
|
Randomized-treatment Period
COMPLETED
|
3
|
7
|
8
|
7
|
8
|
7
|
14
|
0
|
|
Randomized-treatment Period
NOT COMPLETED
|
2
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Open-label Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
|
Open-label Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Open-label Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
OnabotulinumtoxinA Dose 1
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
|
OnabotulinumtoxinA Dose 3
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 4
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 5
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 6
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
|
Placebo
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2 (Open-label Period)
Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.
|
|---|---|---|---|---|---|---|---|---|
|
Randomized-treatment Period
Lost to Follow-up
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Randomized-treatment Period
Personal Reasons
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Randomized-treatment Period
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Randomized-treatment Period
Other Miscellaneous Reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Open-label Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-label Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
Baseline characteristics by cohort
| Measure |
OnabotulinumtoxinA Dose 1
n=5 Participants
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2
n=7 Participants
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
|
OnabotulinumtoxinA Dose 3
n=8 Participants
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 4
n=7 Participants
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 5
n=8 Participants
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 6
n=7 Participants
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
|
Placebo
n=15 Participants
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 10.83 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 11.65 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 5.62 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 9.05 • n=4 Participants
|
40.1 years
STANDARD_DEVIATION 6.53 • n=21 Participants
|
39.9 years
STANDARD_DEVIATION 5.96 • n=8 Participants
|
41.0 years
STANDARD_DEVIATION 6.08 • n=8 Participants
|
40.4 years
STANDARD_DEVIATION 7.41 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
57 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
6 participants
n=8 Participants
|
9 participants
n=8 Participants
|
37 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
3 participants
n=8 Participants
|
9 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
4 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
2 participants
n=8 Participants
|
5 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
2 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: The modified intent-to-treat (mITT) population included all randomized participants who received study treatment and had post-baseline intravaginal ejaculatory latency time (IELT) data available based on the dose actually received by the participant. Number analyzed is the number of participants with available data at the given time-point.
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
OnabotulinumtoxinA Dose 1
n=5 Participants
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2
n=7 Participants
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
|
OnabotulinumtoxinA Dose 3
n=8 Participants
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 4
n=7 Participants
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 5
n=8 Participants
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 6
n=7 Participants
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
|
Placebo
n=15 Participants
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
Baseline
|
3.57 log(seconds)
Standard Deviation 0.283
|
3.50 log(seconds)
Standard Deviation 0.631
|
3.46 log(seconds)
Standard Deviation 0.371
|
3.52 log(seconds)
Standard Deviation 0.531
|
3.53 log(seconds)
Standard Deviation 0.475
|
3.54 log(seconds)
Standard Deviation 0.505
|
3.46 log(seconds)
Standard Deviation 0.610
|
|
Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
Change from Baseline to Week 12
|
0.55 log(seconds)
Standard Deviation 1.037
|
0.69 log(seconds)
Standard Deviation 1.426
|
0.05 log(seconds)
Standard Deviation 0.856
|
0.30 log(seconds)
Standard Deviation 0.472
|
0.31 log(seconds)
Standard Deviation 0.525
|
0.59 log(seconds)
Standard Deviation 0.719
|
0.44 log(seconds)
Standard Deviation 0.615
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12Population: The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participants. Number analyzed is the number of participants with available data at the given time-point.
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The average of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of average IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline average mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
OnabotulinumtoxinA Dose 1
n=5 Participants
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2
n=7 Participants
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
|
OnabotulinumtoxinA Dose 3
n=8 Participants
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 4
n=7 Participants
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 5
n=8 Participants
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 6
n=7 Participants
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
|
Placebo
n=15 Participants
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Average IELT
Change from Baseline to Week 2
|
66.25 seconds
Standard Deviation 101.132
|
180.31 seconds
Standard Deviation 317.657
|
24.73 seconds
Standard Deviation 59.725
|
34.87 seconds
Standard Deviation 74.842
|
28.04 seconds
Standard Deviation 31.298
|
55.77 seconds
Standard Deviation 65.549
|
11.25 seconds
Standard Deviation 23.985
|
|
Change From Baseline in Average IELT
Baseline
|
37.25 seconds
Standard Deviation 10.518
|
39.42 seconds
Standard Deviation 21.504
|
34.41 seconds
Standard Deviation 10.194
|
38.00 seconds
Standard Deviation 16.008
|
40.88 seconds
Standard Deviation 16.435
|
38.75 seconds
Standard Deviation 15.596
|
37.92 seconds
Standard Deviation 16.656
|
|
Change From Baseline in Average IELT
Change from Baseline to Week 4
|
61.94 seconds
Standard Deviation 100.446
|
176.71 seconds
Standard Deviation 367.665
|
24.06 seconds
Standard Deviation 59.472
|
35.00 seconds
Standard Deviation 73.475
|
28.46 seconds
Standard Deviation 36.881
|
64.97 seconds
Standard Deviation 67.471
|
29.30 seconds
Standard Deviation 69.073
|
|
Change From Baseline in Average IELT
Change from Baseline to Week 6
|
61.42 seconds
Standard Deviation 100.446
|
183.44 seconds
Standard Deviation 374.404
|
20.75 seconds
Standard Deviation 55.850
|
36.95 seconds
Standard Deviation 71.996
|
29.35 seconds
Standard Deviation 39.334
|
64.49 seconds
Standard Deviation 66.546
|
47.62 seconds
Standard Deviation 89.847
|
|
Change From Baseline in Average IELT
Change from Baseline to Week 8
|
59.55 seconds
Standard Deviation 100.896
|
176.59 seconds
Standard Deviation 349.777
|
17.08 seconds
Standard Deviation 44.158
|
37.69 seconds
Standard Deviation 71.873
|
29.48 seconds
Standard Deviation 44.505
|
65.19 seconds
Standard Deviation 65.612
|
65.57 seconds
Standard Deviation 128.470
|
|
Change From Baseline in Average IELT
Change from Baseline to Week 10
|
56.13 seconds
Standard Deviation 101.447
|
170.65 seconds
Standard Deviation 331.039
|
15.55 seconds
Standard Deviation 39.149
|
37.45 seconds
Standard Deviation 71.782
|
27.49 seconds
Standard Deviation 45.365
|
63.91 seconds
Standard Deviation 67.725
|
68.26 seconds
Standard Deviation 146.330
|
|
Change From Baseline in Average IELT
Change from Baseline to Week 12
|
53.65 seconds
Standard Deviation 102.527
|
152.74 seconds
Standard Deviation 295.219
|
12.95 seconds
Standard Deviation 30.930
|
28.32 seconds
Standard Deviation 48.965
|
27.51 seconds
Standard Deviation 48.720
|
66.01 seconds
Standard Deviation 71.489
|
68.49 seconds
Standard Deviation 151.680
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10Population: The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participant. Number analyzed is the number of participants with available data at the given time-point.
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of log-transformed geometric mean IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
OnabotulinumtoxinA Dose 1
n=5 Participants
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2
n=7 Participants
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
|
OnabotulinumtoxinA Dose 3
n=8 Participants
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 4
n=7 Participants
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 5
n=8 Participants
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 6
n=7 Participants
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
|
Placebo
n=15 Participants
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Geometric Mean IELT
Baseline
|
3.57 log(seconds)
Standard Deviation 0.283
|
3.50 log(seconds)
Standard Deviation 0.631
|
3.46 log(seconds)
Standard Deviation 0.371
|
3.52 log(seconds)
Standard Deviation 0.531
|
3.53 log(seconds)
Standard Deviation 0.475
|
3.54 log(seconds)
Standard Deviation 0.505
|
3.46 log(seconds)
Standard Deviation 0.610
|
|
Change From Baseline in Geometric Mean IELT
Change from Baseline to Week 2
|
0.76 log(seconds)
Standard Deviation 1.014
|
0.95 log(seconds)
Standard Deviation 1.497
|
0.26 log(seconds)
Standard Deviation 0.677
|
0.34 log(seconds)
Standard Deviation 0.690
|
0.47 log(seconds)
Standard Deviation 0.604
|
0.62 log(seconds)
Standard Deviation 0.623
|
0.19 log(seconds)
Standard Deviation 0.486
|
|
Change From Baseline in Geometric Mean IELT
Change from Baseline to Week 4
|
0.70 log(seconds)
Standard Deviation 1.000
|
0.77 log(seconds)
Standard Deviation 1.505
|
0.18 log(seconds)
Standard Deviation 0.879
|
0.33 log(seconds)
Standard Deviation 0.616
|
0.38 log(seconds)
Standard Deviation 0.481
|
0.61 log(seconds)
Standard Deviation 0.618
|
0.22 log(seconds)
Standard Deviation 0.627
|
|
Change From Baseline in Geometric Mean IELT
Change from Baseline to Week 6
|
0.70 log(seconds)
Standard Deviation 0.999
|
0.83 log(seconds)
Standard Deviation 1.513
|
0.08 log(seconds)
Standard Deviation 0.971
|
0.36 log(seconds)
Standard Deviation 0.629
|
0.36 log(seconds)
Standard Deviation 0.483
|
0.59 log(seconds)
Standard Deviation 0.722
|
0.36 log(seconds)
Standard Deviation 0.524
|
|
Change From Baseline in Geometric Mean IELT
Change from Baseline to Week 8
|
0.67 log(seconds)
Standard Deviation 1.007
|
0.79 log(seconds)
Standard Deviation 1.525
|
0.05 log(seconds)
Standard Deviation 0.968
|
0.37 log(seconds)
Standard Deviation 0.627
|
0.36 log(seconds)
Standard Deviation 0.522
|
0.61 log(seconds)
Standard Deviation 0.682
|
0.44 log(seconds)
Standard Deviation 0.567
|
|
Change From Baseline in Geometric Mean IELT
Change from Baseline to Week 10
|
0.60 log(seconds)
Standard Deviation 1.009
|
0.80 log(seconds)
Standard Deviation 1.503
|
0.07 log(seconds)
Standard Deviation 0.905
|
0.37 log(seconds)
Standard Deviation 0.624
|
0.32 log(seconds)
Standard Deviation 0.512
|
0.56 log(seconds)
Standard Deviation 0.727
|
0.44 log(seconds)
Standard Deviation 0.603
|
Adverse Events
OnabotulinumtoxinA Dose 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OnabotulinumtoxinA Dose 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OnabotulinumtoxinA Dose 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
OnabotulinumtoxinA Dose 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OnabotulinumtoxinA Dose 5
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OnabotulinumtoxinA Dose 6
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
OnabotulinumtoxinA Dose 2 (Open-label Period)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OnabotulinumtoxinA Dose 1
n=5 participants at risk
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2
n=7 participants at risk
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 3
n=8 participants at risk
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 4
n=8 participants at risk
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 5
n=8 participants at risk
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 6
n=8 participants at risk
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
|
Placebo
n=15 participants at risk
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
|
OnabotulinumtoxinA Dose 2 (Open-label Period)
n=8 participants at risk
Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
General disorders
Injection site pain
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
General disorders
Chills
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
General disorders
Injection site pruritus
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
14.3%
1/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
20.0%
3/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Ear infection
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Investigations
Semen volume decreased
|
40.0%
2/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
13.3%
2/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Investigations
Heart rate irregular
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
20.0%
3/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
20.0%
3/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Psychiatric disorders
Psychogenic erectile dysfunction
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
14.3%
1/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Renal and urinary disorders
Terminal dribbling
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
14.3%
1/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
60.0%
3/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
13.3%
2/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Reproductive system and breast disorders
Epididymal tenderness
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Reproductive system and breast disorders
Ejaculation failure
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
6.7%
1/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
12.5%
1/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/5 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
14.3%
1/7 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/15 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
0.00%
0/8 • First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment. Safety Population included all treated participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER