Trial Outcomes & Findings for A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas (NCT NCT02147158)
NCT ID: NCT02147158
Last Updated: 2019-06-04
Results Overview
Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
432 participants
Primary outcome timeframe
Last 35 consecutive days on treatment in the 12-Week Treatment Course 1
Results posted on
2019-06-04
Participant Flow
Participant milestones
| Measure |
UPA 5 mg:Placebo
Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
|
UPA 10 mg:Placebo
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
|
UPA 5 mg:UPA 5 mg
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
|
UPA 10 mg:UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
|
Placebo:UPA 5 mg
Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
|
Placebo:UPA 10 mg
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
|
|---|---|---|---|---|---|---|
|
Treatment Course 1
STARTED
|
55
|
47
|
107
|
110
|
55
|
58
|
|
Treatment Course 1
COMPLETED
|
51
|
38
|
99
|
97
|
49
|
50
|
|
Treatment Course 1
NOT COMPLETED
|
4
|
9
|
8
|
13
|
6
|
8
|
|
Off-Treatment Interval 1
STARTED
|
51
|
38
|
99
|
97
|
49
|
50
|
|
Off-Treatment Interval 1
COMPLETED
|
41
|
34
|
84
|
82
|
41
|
45
|
|
Off-Treatment Interval 1
NOT COMPLETED
|
10
|
4
|
15
|
15
|
8
|
5
|
|
Treatment Course 2
STARTED
|
41
|
34
|
84
|
82
|
41
|
45
|
|
Treatment Course 2
COMPLETED
|
40
|
29
|
79
|
77
|
41
|
43
|
|
Treatment Course 2
NOT COMPLETED
|
1
|
5
|
5
|
5
|
0
|
2
|
|
Off-Treatment Interval 2
STARTED
|
40
|
29
|
79
|
77
|
41
|
43
|
|
Off-Treatment Interval 2
COMPLETED
|
36
|
25
|
69
|
66
|
39
|
39
|
|
Off-Treatment Interval 2
NOT COMPLETED
|
4
|
4
|
10
|
11
|
2
|
4
|
Reasons for withdrawal
| Measure |
UPA 5 mg:Placebo
Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
|
UPA 10 mg:Placebo
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
|
UPA 5 mg:UPA 5 mg
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
|
UPA 10 mg:UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
|
Placebo:UPA 5 mg
Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
|
Placebo:UPA 10 mg
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
|
|---|---|---|---|---|---|---|
|
Treatment Course 1
Adverse Event
|
1
|
4
|
3
|
4
|
1
|
2
|
|
Treatment Course 1
Lost to Follow-up
|
2
|
4
|
3
|
3
|
2
|
4
|
|
Treatment Course 1
Protocol Violation
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Treatment Course 1
Withdrawal of Consent
|
1
|
1
|
1
|
5
|
3
|
2
|
|
Off-Treatment Interval 1
Adverse Event
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Off-Treatment Interval 1
Lost to Follow-up
|
2
|
1
|
3
|
2
|
4
|
2
|
|
Off-Treatment Interval 1
Protocol Violation
|
1
|
0
|
2
|
0
|
1
|
0
|
|
Off-Treatment Interval 1
Withdrawal of Consent
|
4
|
3
|
5
|
10
|
2
|
3
|
|
Off-Treatment Interval 1
Lack of Efficacy
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Off-Treatment Interval 1
Other Miscellaneous Reasons
|
2
|
0
|
3
|
2
|
0
|
0
|
|
Treatment Course 2
Adverse Event
|
0
|
4
|
2
|
1
|
0
|
1
|
|
Treatment Course 2
Withdrawal of Consent
|
0
|
1
|
2
|
3
|
0
|
0
|
|
Treatment Course 2
Lost to Follow-up
|
1
|
0
|
1
|
1
|
0
|
1
|
|
Off-Treatment Interval 2
Lack of Efficacy
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Off-Treatment Interval 2
Withdrawal of Consent
|
4
|
0
|
5
|
4
|
0
|
1
|
|
Off-Treatment Interval 2
Lost to Follow-up
|
0
|
0
|
3
|
2
|
2
|
2
|
|
Off-Treatment Interval 2
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Off-Treatment Interval 2
Other Miscellaneous Reasons
|
0
|
3
|
1
|
4
|
0
|
1
|
Baseline Characteristics
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
Baseline characteristics by cohort
| Measure |
UPA 5 mg:Placebo
n=55 Participants
Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
|
UPA 10 mg:Placebo
n=47 Participants
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
|
UPA 5 mg:UPA 5 mg
n=107 Participants
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
|
UPA 10 mg:UPA 10 mg
n=110 Participants
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
|
Placebo:UPA 5 mg
n=55 Participants
Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
|
Placebo:UPA 10 mg
n=58 Participants
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
|
Total
n=432 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
40.9 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
40.8 years
STANDARD_DEVIATION 5.1 • n=21 Participants
|
40.7 years
STANDARD_DEVIATION 4.6 • n=10 Participants
|
41.0 years
STANDARD_DEVIATION 5.6 • n=115 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
432 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Last 35 consecutive days on treatment in the 12-Week Treatment Course 1Population: Intent-to-Treat (ITT) Population included all randomized participants. Data was summarized as per the treatment assigned.
Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.
Outcome measures
| Measure |
Placebo
n=113 Participants
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 5 mg
n=162 Participants
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 10 mg
n=157 Participants
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
|---|---|---|---|
|
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1
|
0.0 percentage of participants
Interval 0.0 to 3.8
|
42.0 percentage of participants
Interval 33.3 to 51.1
|
54.8 percentage of participants
Interval 45.5 to 63.8
|
PRIMARY outcome
Timeframe: From first dose up to the end of the 12-Week Treatment Course 1Population: ITT population included all randomized participants. Data was summarized per treatment assigned.
Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.
Outcome measures
| Measure |
Placebo
n=113 Participants
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 5 mg
n=162 Participants
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 10 mg
n=157 Participants
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
|---|---|---|---|
|
Time to Absence of Bleeding on Treatment During Treatment Course 1
|
NA days
Median and Confidence Interval (CI) were not estimable due to low number of participants with events.
|
NA days
Interval 48.0 to
Median and CI upper limit were not estimable due to low number of participants with events.
|
36.0 days
Interval 7.0 to
CI upper limit was not estimable due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Day 11 through the end of treatment in the 12-Week Treatment Course 1Population: ITT population included all randomized participants. Data was summarized as per the treatment assigned.
Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), from Day 11 to the end of treatment in Treatment Course 1.
Outcome measures
| Measure |
Placebo
n=113 Participants
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 5 mg
n=162 Participants
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 10 mg
n=157 Participants
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
|---|---|---|---|
|
Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1
|
0.0 percentage of participants
Interval 0.0 to 3.8
|
34.6 percentage of participants
Interval 26.3 to 43.5
|
55.4 percentage of participants
Interval 46.2 to 64.4
|
SECONDARY outcome
Timeframe: Last 35 consecutive days on treatment in the 12-Week Treatment Course 2Population: Data was summarized as per the treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.
Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 2.
Outcome measures
| Measure |
Placebo
n=75 Participants
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 5 mg
n=84 Participants
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 10 mg
n=82 Participants
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
|---|---|---|---|
|
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2
|
8.0 percentage of participants
Interval 2.6 to 17.9
|
40.5 percentage of participants
Interval 28.5 to 53.3
|
57.3 percentage of participants
Interval 44.4 to 69.6
|
SECONDARY outcome
Timeframe: From first dose up to the end of treatment in the 12-Week Treatment Course 2Population: Data was summarized as per treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.
Time to absence of bleeding is defined as the duration in days from first dose in treatment course 2 to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the second treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 2.
Outcome measures
| Measure |
Placebo
n=75 Participants
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 5 mg
n=84 Participants
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 10 mg
n=82 Participants
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
|---|---|---|---|
|
Time to Absence of Bleeding on Treatment During Treatment Course 2
|
NA days
Median and CI were not estimable due to low number of participants with events.
|
NA days
Interval 37.0 to
Median and CI upper limit were not estimable due to low number of participants with events.
|
7.5 days
Interval 5.0 to
CI upper limit was not estimable due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline (Day 1-4) to End of 12-Week Treatment Course 1Population: Data was summarized as per treatment assigned and included all participants with data at both Baseline and Week 12 in Treatment Course 1.
The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=95 Participants
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 5 mg
n=146 Participants
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
UPA 10 mg
n=132 Participants
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
|
|---|---|---|---|
|
Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1
Baseline
|
28.70 score on a scale
Standard Deviation 24.56
|
27.52 score on a scale
Standard Deviation 24.05
|
33.24 score on a scale
Standard Deviation 27.00
|
|
Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1
Change from Baseline at Week 12
|
14.25 score on a scale
Standard Deviation 28.77
|
50.19 score on a scale
Standard Deviation 32.07
|
54.73 score on a scale
Standard Deviation 32.32
|
Adverse Events
Placebo (Treatment Course 1)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
UPA 5 mg (Treatment Course 1)
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
UPA 10 mg (Treatment Course 1)
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
UPA 5 mg:Placebo (Treatment Course 2)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
UPA 10 mg:Placebo (Treatment Course 2)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
UPA 5 mg:UPA 5 mg (Treatment Course 2)
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
UPA 10 mg:UPA 10 mg (Treatment Course 2)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo:UPA 5 mg (Treatment Course 2)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo:UPA 10 mg (Treatment Course 2)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Treatment Course 1)
n=116 participants at risk
Matching placebo tablets, orally, once daily for 12 weeks in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
|
UPA 5 mg (Treatment Course 1)
n=161 participants at risk
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
|
UPA 10 mg (Treatment Course 1)
n=155 participants at risk
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
|
UPA 5 mg:Placebo (Treatment Course 2)
n=40 participants at risk
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by placebo matching tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
UPA 10 mg:Placebo (Treatment Course 2)
n=33 participants at risk
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
UPA 5 mg:UPA 5 mg (Treatment Course 2)
n=84 participants at risk
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
UPA 10 mg:UPA 10 mg (Treatment Course 2)
n=82 participants at risk
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
Placebo:UPA 5 mg (Treatment Course 2)
n=42 participants at risk
Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
Placebo:UPA 10 mg (Treatment Course 2)
n=44 participants at risk
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.62%
1/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.62%
1/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.4%
1/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.2%
1/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.62%
1/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Investigations
Liver function test abnormal
|
0.86%
1/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Infections and infestations
Meningitis viral
|
0.86%
1/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.3%
1/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.86%
1/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
General disorders
Non-cardiac chest pain
|
0.86%
1/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
3.0%
1/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.62%
1/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.2%
1/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Gastrointestinal disorders
Vomiting
|
0.86%
1/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.65%
1/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.2%
1/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.2%
1/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Nervous system disorders
Syncope
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
3.0%
1/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
Other adverse events
| Measure |
Placebo (Treatment Course 1)
n=116 participants at risk
Matching placebo tablets, orally, once daily for 12 weeks in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
|
UPA 5 mg (Treatment Course 1)
n=161 participants at risk
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
|
UPA 10 mg (Treatment Course 1)
n=155 participants at risk
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
|
UPA 5 mg:Placebo (Treatment Course 2)
n=40 participants at risk
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by placebo matching tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
UPA 10 mg:Placebo (Treatment Course 2)
n=33 participants at risk
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
UPA 5 mg:UPA 5 mg (Treatment Course 2)
n=84 participants at risk
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
UPA 10 mg:UPA 10 mg (Treatment Course 2)
n=82 participants at risk
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
Placebo:UPA 5 mg (Treatment Course 2)
n=42 participants at risk
Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
Placebo:UPA 10 mg (Treatment Course 2)
n=44 participants at risk
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.3%
5/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
8.1%
13/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.6%
4/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
6.1%
2/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
3.6%
3/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
6.8%
3/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
General disorders
Fatigue
|
4.3%
5/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
3.7%
6/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
5.2%
8/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
2/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
5.0%
8/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.3%
2/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Nervous system disorders
Headache
|
5.2%
6/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
4.3%
7/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
10.3%
16/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
6.1%
2/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
6.0%
5/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.2%
1/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
7.1%
3/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.3%
1/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Vascular disorders
Hot flush
|
1.7%
2/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
7.5%
12/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
11.6%
18/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
6.0%
5/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
4.9%
4/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.4%
1/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
4.5%
2/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
7.5%
3/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
9.1%
3/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.2%
1/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
7.1%
3/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.3%
1/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
6.1%
2/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.4%
2/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.3%
1/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
6.1%
2/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.2%
1/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
5.0%
2/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
5.0%
2/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.2%
1/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
5.0%
2/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.4%
2/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.4%
2/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
2.3%
1/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/116 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/161 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/155 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
7.5%
3/40 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/33 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
1.2%
1/84 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/82 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/42 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
0.00%
0/44 • From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
|
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