Trial Outcomes & Findings for A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy (NCT NCT04641962)
NCT ID: NCT04641962
Last Updated: 2025-07-03
Results Overview
6MWT assessed functional capacity and endurance by measuring the distance walked in 6 minutes. This test helped to assess exercise tolerance, physical fitness, disease progression, and treatment effectiveness in individuals with myopathy. The total distance walked by a participant, as well as distance per minute was calculated by rounding to the nearest meter.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Baseline, week 24
Results posted on
2025-07-03
Participant Flow
Participants with Primary Mitochondrial Myopathy were enrolled in the study.
Participants meeting all inclusion \& no exclusion criteria were enrolled. Protocol version 7.0 included 4-week (wk) screening, 2 week\_phase 2 dose selection portion, up to 52-wk double-blind treatment (DBT), 24-week open-label extension (OLE) \& 4 wk follow-up (FU), totaling to 84 wks. Protocol v9.0: modified to 4-week screening, 24-wk DBT, 4-wk FU. Some participants received DB treatment up to 52 weeks, resulting in efficacy reported for up to 24 weeks and safety for up to 52 wks.
Participant milestones
| Measure |
DBT: Bocidelpar 30 mg
Participants received Bocidelpar 30 mgs orally once daily during the double blind treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Bocidelpar 75 mg
Participants received Bocidelpar 75 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
Bocidelpar 30 mg or 75mg to Open Label Extension Period: Bocidelpar 30 mg
Participants received Bocidelpar 30 mg or 75 mg orally once daily during the DB treatment period and received 30 mg Bocidelpar in the OLE period.
|
DBT: Placebo
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
Placebo to OLE Period: Bocidelpar 30 mg
Participants received Bocidelpar matching placebo orally once daily during the DB period and received 30mg Bocidelpar in the OLE period.
|
|---|---|---|---|---|---|
|
DBT Period: Up to 52 Weeks
STARTED
|
12
|
11
|
0
|
11
|
0
|
|
DBT Period: Up to 52 Weeks
COMPLETED
|
5
|
5
|
0
|
3
|
0
|
|
DBT Period: Up to 52 Weeks
NOT COMPLETED
|
7
|
6
|
0
|
8
|
0
|
|
OLE Treatment Period: Up to 76 Weeks
STARTED
|
0
|
0
|
10
|
0
|
3
|
|
OLE Treatment Period: Up to 76 Weeks
COMPLETED
|
0
|
0
|
5
|
0
|
2
|
|
OLE Treatment Period: Up to 76 Weeks
NOT COMPLETED
|
0
|
0
|
5
|
0
|
1
|
Reasons for withdrawal
| Measure |
DBT: Bocidelpar 30 mg
Participants received Bocidelpar 30 mgs orally once daily during the double blind treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Bocidelpar 75 mg
Participants received Bocidelpar 75 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
Bocidelpar 30 mg or 75mg to Open Label Extension Period: Bocidelpar 30 mg
Participants received Bocidelpar 30 mg or 75 mg orally once daily during the DB treatment period and received 30 mg Bocidelpar in the OLE period.
|
DBT: Placebo
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
Placebo to OLE Period: Bocidelpar 30 mg
Participants received Bocidelpar matching placebo orally once daily during the DB period and received 30mg Bocidelpar in the OLE period.
|
|---|---|---|---|---|---|
|
DBT Period: Up to 52 Weeks
Miscellaneous
|
5
|
3
|
0
|
3
|
0
|
|
DBT Period: Up to 52 Weeks
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
DBT Period: Up to 52 Weeks
Protocol deviation
|
1
|
0
|
0
|
2
|
0
|
|
DBT Period: Up to 52 Weeks
Death
|
1
|
0
|
0
|
0
|
0
|
|
DBT Period: Up to 52 Weeks
Adverse Event
|
0
|
3
|
0
|
2
|
0
|
|
OLE Treatment Period: Up to 76 Weeks
Miscellaneous
|
0
|
0
|
4
|
0
|
1
|
|
OLE Treatment Period: Up to 76 Weeks
Death
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy
Baseline characteristics by cohort
| Measure |
DBT Bocidelpar 30 mg
n=12 Participants
Participants received Bocidelpar 30 mg orally once daily during the double blind treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=11 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=11 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.0 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
33.8 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
41.7 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
38.2 Years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
|
6 minute walk test (6MWT)
|
396.3 Meters
STANDARD_DEVIATION 104.7 • n=5 Participants
|
390.0 Meters
STANDARD_DEVIATION 110.6 • n=7 Participants
|
422.1 Meters
STANDARD_DEVIATION 70.5 • n=5 Participants
|
402.6 Meters
STANDARD_DEVIATION 95.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 24Population: Full analysis set (FAS) All randomized participants who received at least 1 dose of study drug or placebo and had at least 1 post-baseline efficacy measurement. FAS with available data was analyzed.
6MWT assessed functional capacity and endurance by measuring the distance walked in 6 minutes. This test helped to assess exercise tolerance, physical fitness, disease progression, and treatment effectiveness in individuals with myopathy. The total distance walked by a participant, as well as distance per minute was calculated by rounding to the nearest meter.
Outcome measures
| Measure |
DBT Bocidelpar 30 mg
n=11 Participants
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=11 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=10 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Distanced Walked During a 6 Minute Walk Test (6MWT).
|
25.3 Meters
Standard Deviation 21.4
|
28.6 Meters
Standard Deviation 73.3
|
17.7 Meters
Standard Deviation 47.8
|
—
|
PRIMARY outcome
Timeframe: From first dose up to week 52Population: SAF
An Adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, and which dint have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE was defined as an AE observed after starting administration of the study drug through 28 days after the last dose.
Outcome measures
| Measure |
DBT Bocidelpar 30 mg
n=12 Participants
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=11 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=23 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=11 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
11 Participants
|
11 Participants
|
22 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: From the first dose up to week 52Population: SAF
The C-SSRS was a questionnaire used for suicide risk assessment. Affirmative or negative responses were provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods \[not plan\] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). The overall data was reported.
Outcome measures
| Measure |
DBT Bocidelpar 30 mg
n=12 Participants
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=11 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=23 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=11 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation and/ or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: FAS with available data was analyzed.
The Neuro-QoL Short Form Fatigue score was an 8-item self- assessment questionnaire evaluating the perception of fatigue and its impact in daily life activities. Participants had five response options for each item: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always. The questionnaire was scored by adding the response to each of the item and then transformed into T-scores based on the scoring manual with a score range of minimum=29.5, maximum=74.1. T-score distributions rescaled raw scores into standardized scores with a mean of 50 and a SD of 10. Higher scores indicated a greater level of fatigue.
Outcome measures
| Measure |
DBT Bocidelpar 30 mg
n=8 Participants
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=8 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=6 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Short Form Fatigue Score
|
-4.04 T score
Standard Deviation 4.59
|
-1.09 T score
Standard Deviation 4.40
|
-2.82 T score
Standard Deviation 8.63
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: FAS with available data were analyzed.
The Neuro-QoL Short Form Lower Extremity Function (Mobility) score was an 8-item self- assessment questionnaire evaluating the functioning of one's lower extremities. Participants responded to questions on a 1-5 scale. Participants had five response options for each item: 1=Unable to do,2=With much difficulty,3=With some difficulty,4=With a little difficulty, 5=Without any difficult. The questionnaire was scored by adding the response to each of the item and then transformed into T-scores based on the scoring manual with a score range of minimum=16.5, maximum=58.6. T-score distributions rescaled raw scores into standardized scores with a mean of 50 and a SD of 10. Higher scores indicated better function.
Outcome measures
| Measure |
DBT Bocidelpar 30 mg
n=8 Participants
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=8 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=6 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Neuro-QoL Short Form Lower Extremity Function (Mobility) Scores
|
2.49 T scoree
Standard Deviation 3.36
|
1.68 T scoree
Standard Deviation 3.67
|
2.50 T scoree
Standard Deviation 6.02
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: FAS with available participants were analyzed.
The 5XSTS test was a functional assessment that measured the time taken to stand up from a seated position five times in a row, as quickly as possible. The duration from the time instructor indicated "Go" until the time participant's body touched the chair following the fifth repetition was recorded and reported.
Outcome measures
| Measure |
DBT Bocidelpar 30 mg
n=8 Participants
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=7 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=6 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Time to Perform the 5 Times Sit to Stand (5XSTS) Test
|
-1.1 Seconds
Standard Deviation 2.6
|
-0.9 Seconds
Standard Deviation 2.6
|
-1.5 Seconds
Standard Deviation 2.7
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: FAS with available data were analyzed.
The PGIC scale evaluated the participant's symptom and assessed if there had been any improvement or decline in clinical status. The participant rated their perceived change on a 7-point scale, with 1 indicating very much improved, 2 = Much Improved, 3=Minimally Improved, 4= No Change, 5=Minimally Worse, 6=Much Worse and 7 indicating 'very much worse".
Outcome measures
| Measure |
DBT Bocidelpar 30 mg
n=9 Participants
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=8 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=7 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
|---|---|---|---|---|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Score at Week 24
Minimally Improved
|
3 participants
|
2 participants
|
3 participants
|
—
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Score at Week 24
Very Much Improved
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Score at Week 24
Much Improved
|
1 participants
|
1 participants
|
2 participants
|
—
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Score at Week 24
No Change
|
4 participants
|
4 participants
|
1 participants
|
—
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Score at Week 24
Minimally Worse
|
0 participants
|
1 participants
|
1 participants
|
—
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Score at Week 24
Much Worse
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Patient's Global Impression of Change (PGIC) Score at Week 24
Very Much Worse
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: FAS with available data were analyzed.
PGIS score was a patient-reported measure that reflected the individual's overall perception of the severity of their condition on a Likert scale. PGIS score were calculated as -1= mild change from baseline, -2=moderate change from baseline,-3=severe change from baseline,0= none, 1= mild, 2= moderate and 3= severe. The questionnaire asked the participant to best describe the severity of the participant's most bothersome pre-defined symptom over the past week.
Outcome measures
| Measure |
DBT Bocidelpar 30 mg
n=8 Participants
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=8 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=6 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) at Week 24
-3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) at Week 24
-2
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) at Week 24
-1
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Number of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) at Week 24
0
|
4 Participants
|
5 Participants
|
2 Participants
|
—
|
|
Number of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) at Week 24
1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) at Week 24
2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) at Week 24
3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: FAS with available data was analyzed.
MFIS was a self-reported questionnaire designed to evaluate the impact of fatigue on physical, cognitive and psychosocial functioning. The MFIS consisted of 21 items scored 0-4 (0=Never, 1=Rarely, 2=Sometimes, 3=Often, and 4=Almost always). The total MFIS score ranged from 0 to 84, with three subscales: Physical range 0-36, Cognitive range 0-40, and Psychosocial range 0-8. Higher scores indicated higher level of fatigue.
Outcome measures
| Measure |
DBT Bocidelpar 30 mg
n=8 Participants
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=8 Participants
Participants received Bocidelpar 75 mg orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
n=6 Participants
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT: Placebo
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Modified Fatigue Impact Scale (MFIS)
Physical
|
-3.4 Score on a Scale
Standard Deviation 3.2
|
-1.4 Score on a Scale
Standard Deviation 5.0
|
-4.8 Score on a Scale
Standard Deviation 4.9
|
—
|
|
Change From Baseline in Modified Fatigue Impact Scale (MFIS)
Cognitive
|
-1.9 Score on a Scale
Standard Deviation 6.7
|
0.0 Score on a Scale
Standard Deviation 7.8
|
-0.7 Score on a Scale
Standard Deviation 4.0
|
—
|
|
Change From Baseline in Modified Fatigue Impact Scale (MFIS)
Psychosocial
|
-0.8 Score on a Scale
Standard Deviation 1.7
|
-0.6 Score on a Scale
Standard Deviation 1.1
|
-1.8 Score on a Scale
Standard Deviation 2.1
|
—
|
|
Change From Baseline in Modified Fatigue Impact Scale (MFIS)
Total Score
|
-6.0 Score on a Scale
Standard Deviation 8.0
|
-2.0 Score on a Scale
Standard Deviation 11.7
|
-7.3 Score on a Scale
Standard Deviation 9.8
|
—
|
Adverse Events
DBT Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
DBT: Bocidelpar 30 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 1 deaths
DBT Bocidelpar 75 mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo to Open-label Extension Period: Bocidelpar 30 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Bocidelpar 30 mg or 75 mg to Open-label Extension Period: Bocidelpar 30 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
DBT Placebo
n=11 participants at risk
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another4 weeks after the completion of treatment period.
|
DBT: Bocidelpar 30 mg
n=12 participants at risk
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=11 participants at risk
Participants received Bocidelpar 75 mg once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
Placebo to Open-label Extension Period: Bocidelpar 30 mg
n=3 participants at risk
Participants received Bocidelpar matching placebo orally once daily during the DB treatment period and received 30 mg Bocidelpar in the OLE period.
|
Bocidelpar 30 mg or 75 mg to Open-label Extension Period: Bocidelpar 30 mg
n=10 participants at risk
Participants received Bocidelpar 30 mg or 75 mg orally once daily during the DB treatment period and received 30 mg Bocidelpar in the OLE period.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Congenital, familial and genetic disorders
MELAS syndrome
|
9.1%
1/11 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
General disorders
Death
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Troponin I increased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
Other adverse events
| Measure |
DBT Placebo
n=11 participants at risk
Participants received Bocidelpar matching placebo orally once daily during the DB period. The Participants were followed up for another4 weeks after the completion of treatment period.
|
DBT: Bocidelpar 30 mg
n=12 participants at risk
Participants received Bocidelpar 30 mg orally once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
DBT Bocidelpar 75 mg
n=11 participants at risk
Participants received Bocidelpar 75 mg once daily during the DB treatment period. The Participants were followed up for another 4 weeks after the completion of treatment period.
|
Placebo to Open-label Extension Period: Bocidelpar 30 mg
n=3 participants at risk
Participants received Bocidelpar matching placebo orally once daily during the DB treatment period and received 30 mg Bocidelpar in the OLE period.
|
Bocidelpar 30 mg or 75 mg to Open-label Extension Period: Bocidelpar 30 mg
n=10 participants at risk
Participants received Bocidelpar 30 mg or 75 mg orally once daily during the DB treatment period and received 30 mg Bocidelpar in the OLE period.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Congenital, familial and genetic disorders
MELAS syndrome
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Congenital, familial and genetic disorders
Progressive external ophthalmoplegia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Eye disorders
Asthenopia
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Eye disorders
Astigmatism
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
33.3%
1/3 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Eye disorders
Diplopia
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Eye disorders
Eye movement disorder
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Eye disorders
Eye pain
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Eye disorders
Strabismus
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
27.3%
3/11 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
30.0%
3/10 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
16.7%
2/12 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
27.3%
3/11 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
20.0%
2/10 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
General disorders
Asthenia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
33.3%
1/3 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
General disorders
Feeling cold
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
General disorders
Influenza like illness
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
General disorders
Non-cardiac chest pain
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
16.7%
2/12 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
COVID-19
|
27.3%
3/11 • Number of events 4 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
16.7%
2/12 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
36.4%
4/11 • Number of events 4 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
60.0%
6/10 • Number of events 6 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Conjunctivitis
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Lymph gland infection
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
33.3%
1/3 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Viral infection
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
20.0%
2/10 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
18.2%
2/11 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
16.7%
2/12 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Lip injury
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Post vaccination fever
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
25.0%
3/12 • Number of events 4 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
30.0%
3/10 • Number of events 4 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
16.7%
2/12 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
20.0%
2/10 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
25.0%
3/12 • Number of events 4 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
18.2%
2/11 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
30.0%
3/10 • Number of events 5 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Blood phosphorus decreased
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Glutamate dehydrogenase increased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Grip strength decreased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Lipase increased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Transaminases increased
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Troponin T increased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Troponin increased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Investigations
Weight decreased
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Metabolism and nutrition disorders
Gout
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
20.0%
2/10 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Mastication disorder
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
18.2%
2/11 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
30.0%
3/10 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.3%
3/11 • Number of events 4 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
33.3%
1/3 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Balance disorder
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
25.0%
3/12 • Number of events 5 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Memory impairment
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Migraine
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Sciatica
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Nervous system disorders
Seizure
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
33.3%
1/3 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
18.2%
2/11 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.3%
3/11 • Number of events 3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
8.3%
1/12 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
33.3%
1/3 • Number of events 2 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Vascular disorders
Hot flush
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
10.0%
1/10 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
|
Vascular disorders
Pallor
|
0.00%
0/11 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/12 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
9.1%
1/11 • Number of events 1 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/3 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
0.00%
0/10 • Serious/Non Serious AE: From first dose up to week 76 All cause mortality: From randomization up to 76 weeks.
AE occurring after administration of study drug up to 28 days after last dose based on protocol version under which participants were enrolled. • Protocol Version 7.0: Included 52-week DBT period, 24-week OLE \& 4-week follow-up period. • Protocol Version 9.0: Included 24-week DBT period \& 4-week follow-up period. Data on AE was collected up to 76 weeks. The timing of last dose varied among participants, as a result, some participants remained in study for longer than 24 weeks.
|
Additional Information
Clinical Transparency
Astellas Pharma Global Development, Inc
Phone: 8008887704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER