Trial Outcomes & Findings for A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain (NCT NCT03213457)
NCT ID: NCT03213457
Last Updated: 2024-12-20
Results Overview
Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over 35 days prior to each visit. Response was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesic).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
681 participants
Primary outcome timeframe
Month 6, Month 12
Results posted on
2024-12-20
Participant Flow
A total of 679 subjects were treated at 137 sites in 2 countries (US \[including Puerto Rico\] and Canada). Of the 679 subjects who were treated on study, 299 subjects discontinued study drug prematurely during the Placebo-Controlled Treatment Period and 240 discontinued study drug prematurely during the Open-Label Treatment Period.
Participants were randomly assigned on Study Day 1 in a 4:1:2 ratio as follows: * elagolix 200 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) 1 mg/0.5 mg once daily (QD) * elagolix 200 mg BID * placebo Data are presented for the 12-month Placebo-Controlled Treatment Period.
Participant milestones
| Measure |
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix / Elagolix + E2/NETA
Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|---|
|
Screening Period
STARTED
|
194
|
98
|
389
|
|
Screening Period
COMPLETED
|
193
|
97
|
389
|
|
Screening Period
NOT COMPLETED
|
1
|
1
|
0
|
|
Double-Blind Period
STARTED
|
193
|
97
|
389
|
|
Double-Blind Period
COMPLETED
|
157
|
85
|
337
|
|
Double-Blind Period
NOT COMPLETED
|
36
|
12
|
52
|
|
Open-Label Period
STARTED
|
106
|
59
|
215
|
|
Open-Label Period
COMPLETED
|
90
|
48
|
170
|
|
Open-Label Period
NOT COMPLETED
|
16
|
11
|
45
|
|
Follow-Up Period
STARTED
|
194
|
98
|
389
|
|
Follow-Up Period
COMPLETED
|
102
|
51
|
185
|
|
Follow-Up Period
NOT COMPLETED
|
92
|
47
|
204
|
Reasons for withdrawal
| Measure |
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix / Elagolix + E2/NETA
Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|---|
|
Screening Period
Withdrawal by Subject
|
0
|
1
|
0
|
|
Screening Period
Other
|
1
|
0
|
0
|
|
Double-Blind Period
Adverse Event
|
3
|
2
|
7
|
|
Double-Blind Period
Withdrawal by Subject
|
14
|
2
|
14
|
|
Double-Blind Period
Lost to Follow-up
|
2
|
3
|
9
|
|
Double-Blind Period
Requires surgery or invasive intervention for treatment of endometriosis
|
2
|
0
|
1
|
|
Double-Blind Period
Non-compliance with study procedures
|
0
|
2
|
4
|
|
Double-Blind Period
Pregnancy
|
5
|
0
|
0
|
|
Double-Blind Period
Other
|
10
|
3
|
17
|
|
Open-Label Period
Adverse Event
|
1
|
2
|
2
|
|
Open-Label Period
Withdrawal by Subject
|
12
|
5
|
24
|
|
Open-Label Period
Lost to Follow-up
|
1
|
2
|
8
|
|
Open-Label Period
Requires surgery or invasive intervention for treatment of endometriosis
|
0
|
0
|
2
|
|
Open-Label Period
Non-compliance with study procedures
|
1
|
1
|
2
|
|
Open-Label Period
Exclusionary medications
|
0
|
0
|
1
|
|
Open-Label Period
Other
|
1
|
1
|
6
|
|
Follow-Up Period
Adverse Event
|
16
|
8
|
37
|
|
Follow-Up Period
Withdrawal by Subject
|
18
|
11
|
55
|
|
Follow-Up Period
Lost to Follow-up
|
28
|
15
|
50
|
|
Follow-Up Period
Requires surgery or invasive intervention for treatment of endometriosis
|
3
|
1
|
2
|
|
Follow-Up Period
Non-compliance with study procedures
|
4
|
1
|
6
|
|
Follow-Up Period
Pregnancy
|
7
|
0
|
18
|
|
Follow-Up Period
Exclusionary medications
|
1
|
1
|
5
|
|
Follow-Up Period
COVID-19 logistical restrictions
|
1
|
0
|
0
|
|
Follow-Up Period
Other
|
14
|
10
|
31
|
Baseline Characteristics
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=193 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix / Elagolix + E2/NETA
n=97 Participants
Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=389 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Total
n=679 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 6.72 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 6.44 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 6.74 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 6.69 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
193 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
389 Participants
n=5 Participants
|
679 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
573 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
159 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
561 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 6, Month 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over 35 days prior to each visit. Response was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesic).
Outcome measures
| Measure |
Placebo
n=190 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=384 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment
Month 6
|
23.7 percentage of participants
Interval 17.64 to 29.73
|
62.8 percentage of participants
Interval 57.93 to 67.6
|
|
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment
Month 12
|
29.1 percentage of participants
Interval 22.62 to 35.58
|
63.8 percentage of participants
Interval 58.97 to 68.69
|
PRIMARY outcome
Timeframe: Month 6, Month 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit. Response was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics).
Outcome measures
| Measure |
Placebo
n=190 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=384 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment
Month 6
|
36.8 percentage of participants
Interval 29.98 to 43.7
|
51.3 percentage of participants
Interval 46.3 to 56.3
|
|
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment
Month 12
|
42.3 percentage of participants
Interval 35.28 to 49.37
|
54.3 percentage of participants
Interval 49.22 to 59.29
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.
Outcome measures
| Measure |
Placebo
n=111 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=216 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in DYS at Month 12 Based on Daily Assessment
|
-0.73 score on a scale
Standard Error 0.077
|
-1.73 score on a scale
Standard Error 0.055
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort 1. Mild discomfort but I was easily able to do the things I usually do 2. Moderate discomfort or pain that made it difficult to do some of the things I usually do 3. Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.
Outcome measures
| Measure |
Placebo
n=138 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=286 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in DYS at Month 6 Based on Daily Assessment
|
-0.62 score on a scale
Standard Error 0.072
|
-1.64 score on a scale
Standard Error 0.050
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort 1. Mild discomfort but I was easily able to do the things I usually do 2. Moderate discomfort or pain that made it difficult to do some of the things I usually do 3. Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.
Outcome measures
| Measure |
Placebo
n=170 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=335 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in DYS at Month 3 Based on Daily Assessment
|
-0.56 score on a scale
Standard Error 0.069
|
-1.54 score on a scale
Standard Error 0.049
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Outcome measures
| Measure |
Placebo
n=111 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=216 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment
|
-0.64 score on a scale
Standard Error 0.060
|
-0.86 score on a scale
Standard Error 0.042
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Outcome measures
| Measure |
Placebo
n=138 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=286 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in NMPP at Month 6 Based on Daily Assessment
|
-0.57 score on a scale
Standard Error 0.051
|
-0.78 score on a scale
Standard Error 0.036
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Outcome measures
| Measure |
Placebo
n=170 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=335 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in NMPP at Month 3 Based on Daily Assessment
|
-0.49 score on a scale
Standard Error 0.046
|
-0.65 score on a scale
Standard Error 0.032
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.
Outcome measures
| Measure |
Placebo
n=146 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=302 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
|
-4.71 T-score
Standard Error 0.739
|
-7.22 T-score
Standard Error 0.514
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants assessed DYSP each day in an e-Diary according to the following response options: * 0: None; No discomfort during sexual intercourse * 1: Mild; Able to tolerate the discomfort during sexual intercourse * 2: Moderate; Intercourse was interrupted due to pain * 3: Severe; Avoided intercourse because of pain * Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Outcome measures
| Measure |
Placebo
n=84 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=147 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment
|
-0.60 score on a scale
Standard Error 0.079
|
-0.70 score on a scale
Standard Error 0.058
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants assessed DYSP each day in an e-Diary according to the following response options: * 0: None; No discomfort during sexual intercourse * 1: Mild; Able to tolerate the discomfort during sexual intercourse * 2: Moderate; Intercourse was interrupted due to pain * 3: Severe; Avoided intercourse because of pain * Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Outcome measures
| Measure |
Placebo
n=96 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=209 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in DYSP at Month 6 Based on Daily Assessment
|
-0.54 score on a scale
Standard Error 0.076
|
-0.63 score on a scale
Standard Error 0.053
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Participants assessed DYSP each day in an e-Diary according to the following response options: * 0: None; No discomfort during sexual intercourse * 1: Mild; Able to tolerate the discomfort during sexual intercourse * 2: Moderate; Intercourse was interrupted due to pain * 3: Severe; Avoided intercourse because of pain * Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Outcome measures
| Measure |
Placebo
n=119 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=257 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in DYSP at Month 3 Based on Daily Assessment
|
-0.40 score on a scale
Standard Error 0.064
|
-0.62 score on a scale
Standard Error 0.045
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.
Outcome measures
| Measure |
Placebo
n=108 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=220 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
|
-6.43 T-score
Standard Error 0.949
|
-8.92 T-score
Standard Error 0.665
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Outcome measures
| Measure |
Placebo
n=102 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=202 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS)
|
-3.25 score on a scale
Standard Error 0.263
|
-4.39 score on a scale
Standard Error 0.186
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Outcome measures
| Measure |
Placebo
n=130 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=269 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS
|
-2.74 score on a scale
Standard Error 0.248
|
-4.12 score on a scale
Standard Error 0.174
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
Elagolix + E2/NETA
n=304 Participants
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|
|
Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS
|
-2.33 score on a scale
Standard Error 0.225
|
-3.79 score on a scale
Standard Error 0.161
|
Adverse Events
SCR_Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SCR_Elagolix
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SCR_Elagolix_and_E2-NETA
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
DB_Placebo
Serious events: 8 serious events
Other events: 89 other events
Deaths: 0 deaths
DB_Elagolix
Serious events: 2 serious events
Other events: 74 other events
Deaths: 0 deaths
DB_Elagolix_and_E2-NETA
Serious events: 14 serious events
Other events: 236 other events
Deaths: 0 deaths
OL_Placebo_to_ELA_and_E2-NETA
Serious events: 7 serious events
Other events: 60 other events
Deaths: 0 deaths
OL_ELA_to_ELA_and_E2-NETA
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
OL_ELA_and_E2-NETA_to_ELA_and_E2-NETA
Serious events: 10 serious events
Other events: 125 other events
Deaths: 0 deaths
FU_Placebo_to_ELA_and_E2-NETA
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
FU_ELA_to_ELA_and_E2-NETA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FU_ELA_and_E2-NETA_to_ELA_and_E2-NETA
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SCR_Placebo
n=194 participants at risk
Screening (SCR) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
SCR_Elagolix
n=98 participants at risk
Screening (SCR) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
SCR_Elagolix_and_E2-NETA
n=389 participants at risk
Screening (SCR) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
DB_Placebo
n=194 participants at risk
Double-blinded (DB) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
DB_Elagolix
n=98 participants at risk
Double-blinded (DB) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
DB_Elagolix_and_E2-NETA
n=389 participants at risk
Double-blinded (DB) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
OL_Placebo_to_ELA_and_E2-NETA
n=106 participants at risk
Open-Label (OL) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
OL_ELA_to_ELA_and_E2-NETA
n=59 participants at risk
Open-Label (OL) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
OL_ELA_and_E2-NETA_to_ELA_and_E2-NETA
n=215 participants at risk
Open-Label (OL) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
FU_Placebo_to_ELA_and_E2-NETA
n=194 participants at risk
Follow-Up (FU) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
FU_ELA_to_ELA_and_E2-NETA
n=98 participants at risk
Follow-Up (FU) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
FU_ELA_and_E2-NETA_to_ELA_and_E2-NETA
n=389 participants at risk
Follow-Up (FU) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
SINUS NODE DYSFUNCTION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Endocrine disorders
PITUITARY APOPLEXY
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.7%
1/59 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.7%
1/59 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
COVID-19
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Metabolism and nutrition disorders
OBESITY
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PITUITARY TUMOUR
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Nervous system disorders
VESTIBULAR MIGRAINE
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Pregnancy, puerperium and perinatal conditions
CERVICAL INCOMPETENCE
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
2/194 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Reproductive system and breast disorders
HEAVY MENSTRUAL BLEEDING
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Reproductive system and breast disorders
OVARIAN CYST RUPTURED
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.7%
1/59 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/106 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.47%
1/215 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/215 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
Other adverse events
| Measure |
SCR_Placebo
n=194 participants at risk
Screening (SCR) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
SCR_Elagolix
n=98 participants at risk
Screening (SCR) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
SCR_Elagolix_and_E2-NETA
n=389 participants at risk
Screening (SCR) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
DB_Placebo
n=194 participants at risk
Double-blinded (DB) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
DB_Elagolix
n=98 participants at risk
Double-blinded (DB) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
DB_Elagolix_and_E2-NETA
n=389 participants at risk
Double-blinded (DB) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
OL_Placebo_to_ELA_and_E2-NETA
n=106 participants at risk
Open-Label (OL) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
OL_ELA_to_ELA_and_E2-NETA
n=59 participants at risk
Open-Label (OL) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
OL_ELA_and_E2-NETA_to_ELA_and_E2-NETA
n=215 participants at risk
Open-Label (OL) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
FU_Placebo_to_ELA_and_E2-NETA
n=194 participants at risk
Follow-Up (FU) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
FU_ELA_to_ELA_and_E2-NETA
n=98 participants at risk
Follow-Up (FU) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
FU_ELA_and_E2-NETA_to_ELA_and_E2-NETA
n=389 participants at risk
Follow-Up (FU) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.2%
12/194 • Number of events 12 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
16.3%
16/98 • Number of events 19 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
13.1%
51/389 • Number of events 55 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
8.5%
9/106 • Number of events 11 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.4%
2/59 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.6%
12/215 • Number of events 13 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
General disorders
FATIGUE
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.6%
7/194 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.1%
5/98 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.4%
17/389 • Number of events 17 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.8%
4/59 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.9%
4/215 • Number of events 4 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.1%
6/194 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.1%
3/98 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.8%
11/389 • Number of events 11 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.7%
5/106 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
10.2%
6/59 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.2%
9/215 • Number of events 9 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
COVID-19
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
8.5%
9/106 • Number of events 10 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
11.9%
7/59 • Number of events 8 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
13.5%
29/215 • Number of events 32 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.51%
2/389 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.1%
4/194 • Number of events 4 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.3%
9/389 • Number of events 9 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.9%
2/106 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.1%
3/59 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.93%
2/215 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
2/194 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.1%
5/98 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.3%
9/389 • Number of events 9 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.4%
2/59 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.4%
3/215 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.1%
6/194 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.1%
4/98 • Number of events 4 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.1%
16/389 • Number of events 16 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.8%
3/106 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
8.5%
5/59 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.3%
7/215 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.1%
6/194 • Number of events 10 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.1%
5/98 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.4%
21/389 • Number of events 24 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.9%
2/106 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.1%
3/59 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.2%
9/215 • Number of events 10 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.7%
13/194 • Number of events 14 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
10.2%
10/98 • Number of events 10 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
8.2%
32/389 • Number of events 34 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
8.5%
9/106 • Number of events 13 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
8.5%
5/59 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
8.4%
18/215 • Number of events 28 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.6%
7/194 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
7.1%
7/98 • Number of events 8 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.4%
17/389 • Number of events 18 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.7%
6/106 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.7%
1/59 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.0%
13/215 • Number of events 15 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.6%
9/194 • Number of events 10 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
9.2%
9/98 • Number of events 10 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.9%
15/389 • Number of events 15 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.7%
6/106 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
8.5%
5/59 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
7.4%
16/215 • Number of events 19 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.1%
8/194 • Number of events 8 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.1%
3/98 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.1%
16/389 • Number of events 21 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.8%
3/106 • Number of events 4 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.8%
4/59 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.5%
14/215 • Number of events 18 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Investigations
BONE DENSITY DECREASED
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.3%
5/389 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.6%
7/106 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
10.2%
6/59 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
9.8%
21/215 • Number of events 21 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.2%
10/194 • Number of events 10 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.0%
2/98 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.8%
7/389 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.8%
4/106 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.3%
7/215 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.6%
5/194 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.1%
6/98 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.9%
15/389 • Number of events 17 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.7%
6/106 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.1%
3/59 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.7%
8/215 • Number of events 8 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.5%
3/194 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.7%
22/389 • Number of events 22 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.9%
2/106 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.4%
2/59 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
7.0%
15/215 • Number of events 17 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Nervous system disorders
HEADACHE
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.2%
10/194 • Number of events 10 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
13.3%
13/98 • Number of events 13 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
11.8%
46/389 • Number of events 47 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
7.5%
8/106 • Number of events 9 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.8%
4/59 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.3%
7/215 • Number of events 8 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.6%
5/194 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.0%
2/98 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.9%
19/389 • Number of events 24 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.7%
6/106 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.4%
2/59 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.3%
7/215 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.1%
4/194 • Number of events 4 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.1%
3/98 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.6%
18/389 • Number of events 18 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.6%
7/106 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.1%
3/59 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
7.9%
17/215 • Number of events 20 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.1%
4/194 • Number of events 4 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.1%
3/98 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.1%
12/389 • Number of events 13 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.9%
2/106 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.4%
2/59 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
7.0%
15/215 • Number of events 18 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.52%
1/194 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
9.2%
9/98 • Number of events 9 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.3%
13/389 • Number of events 15 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.7%
5/106 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.7%
1/59 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.8%
6/215 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
2/194 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.1%
4/98 • Number of events 4 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.4%
21/389 • Number of events 21 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.9%
2/106 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.8%
6/215 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
1/98 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Reproductive system and breast disorders
INTERMENSTRUAL BLEEDING
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.0%
2/194 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
8.2%
8/98 • Number of events 8 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.6%
18/389 • Number of events 20 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.9%
2/106 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
1.4%
3/215 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.26%
1/389 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.6%
7/194 • Number of events 7 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
5.1%
5/98 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.4%
17/389 • Number of events 17 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.94%
1/106 • Number of events 1 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.93%
2/215 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.1%
6/194 • Number of events 6 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
13.3%
13/98 • Number of events 14 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
6.2%
24/389 • Number of events 25 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.8%
3/106 • Number of events 3 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/59 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
2.3%
5/215 • Number of events 5 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
7.2%
14/194 • Number of events 15 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
43.9%
43/98 • Number of events 44 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
17.7%
69/389 • Number of events 74 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
7.5%
8/106 • Number of events 9 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
3.4%
2/59 • Number of events 2 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
4.7%
10/215 • Number of events 11 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/194 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/98 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
0.00%
0/389 • All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. Arm counts include all randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER