Trial Outcomes & Findings for A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency (NCT NCT01909479)
NCT ID: NCT01909479
Last Updated: 2022-08-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
Baseline to 26 weeks
Results posted on
2022-08-12
Participant Flow
Participant milestones
| Measure |
MOD-4023
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
Placebo: Once weekly administration of placebo
|
|---|---|---|
|
From Baseline to Week 26
STARTED
|
135
|
67
|
|
From Baseline to Week 26
COMPLETED
|
129
|
58
|
|
From Baseline to Week 26
NOT COMPLETED
|
6
|
9
|
|
26 - 52 Weeks
STARTED
|
128
|
58
|
|
26 - 52 Weeks
COMPLETED
|
125
|
56
|
|
26 - 52 Weeks
NOT COMPLETED
|
3
|
2
|
|
52 Weeks to End of Study
STARTED
|
111
|
50
|
|
52 Weeks to End of Study
COMPLETED
|
83
|
35
|
|
52 Weeks to End of Study
NOT COMPLETED
|
28
|
15
|
Reasons for withdrawal
| Measure |
MOD-4023
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
Placebo: Once weekly administration of placebo
|
|---|---|---|
|
From Baseline to Week 26
Adverse Event
|
3
|
2
|
|
From Baseline to Week 26
Withdrawal by Subject
|
3
|
6
|
|
From Baseline to Week 26
Site and study closed by PI
|
0
|
1
|
|
26 - 52 Weeks
Adverse Event
|
0
|
1
|
|
26 - 52 Weeks
Withdrawal by Subject
|
2
|
1
|
|
26 - 52 Weeks
Lost to Follow-up
|
1
|
0
|
|
52 Weeks to End of Study
Withdrawal by Subject
|
18
|
8
|
|
52 Weeks to End of Study
Adverse Event
|
2
|
1
|
|
52 Weeks to End of Study
Death
|
0
|
1
|
|
52 Weeks to End of Study
Lost to Follow-up
|
1
|
0
|
|
52 Weeks to End of Study
Protocol Violation
|
1
|
0
|
|
52 Weeks to End of Study
Progressive disease
|
1
|
1
|
|
52 Weeks to End of Study
Personal reasons
|
2
|
1
|
|
52 Weeks to End of Study
Sponsor's decision
|
1
|
1
|
|
52 Weeks to End of Study
Study termination by sponsor
|
0
|
1
|
|
52 Weeks to End of Study
Lack of contact
|
1
|
0
|
|
52 Weeks to End of Study
Occurrence of malignancy
|
1
|
0
|
|
52 Weeks to End of Study
Diabetes not controlled
|
0
|
1
|
Baseline Characteristics
A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency
Baseline characteristics by cohort
| Measure |
MOD-4023
n=133 Participants
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
n=65 Participants
Placebo: Once weekly administration of placebo
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.9 Year
STANDARD_DEVIATION 12.6 • n=5 Participants
|
43.1 Year
STANDARD_DEVIATION 12.9 • n=7 Participants
|
43.9 Year
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
110 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
15 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
88 participants
n=5 Participants
|
43 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Region of Enrollment
East Asia
|
14 participants
n=5 Participants
|
7 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Weight
|
75.2 Kilogram
STANDARD_DEVIATION 15.0 • n=5 Participants
|
77.8 Kilogram
STANDARD_DEVIATION 17.9 • n=7 Participants
|
75.2 Kilogram
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
BMI
|
27.0 Kilogram/meter^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
27.7 Kilogram/meter^2
STANDARD_DEVIATION 3.5 • n=7 Participants
|
27.0 Kilogram/meter^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 26 weeksPopulation: 198 of the 202 randomized subjects received treatment
Outcome measures
| Measure |
MOD-4023
n=126 Participants
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
n=56 Participants
Placebo: Once weekly administration of placebo
|
|---|---|---|
|
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
|
-0.3 kg
Standard Deviation 1.2
|
0.1 kg
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline to 26 weeksPopulation: 3 subjects discontinued MOD-4023 due to consent withdrawn or lost to follow-up. 2 subjects discontinued placebo due to consent withdrawn or adverse event.
Outcome measures
| Measure |
MOD-4023
n=126 Participants
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
n=56 Participants
Placebo: Once weekly administration of placebo
|
|---|---|---|
|
Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
|
-0.18 kg
Standard Deviation 2.21
|
0.00 kg
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Baseline to 26 weeksPopulation: 3 subjects discontinued MOD-4023 due to consent withdrawn or lost to follow-up. 2 subjects discontinued placebo due to consent withdrawn or adverse event.
Outcome measures
| Measure |
MOD-4023
n=126 Participants
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
n=56 Participants
Placebo: Once weekly administration of placebo
|
|---|---|---|
|
Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
|
1.3 kg
Standard Deviation 2.4
|
0.0 kg
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksOutcome measures
| Measure |
MOD-4023
n=125 Participants
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
n=55 Participants
Placebo: Once weekly administration of placebo
|
|---|---|---|
|
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks
|
-0.2 kg
Standard Deviation 1.6
|
-0.3 kg
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 26 weeks to 52 weeksPopulation: 3 subjects discontinued MOD-4023 due to consent withdrawn or lost to follow-up. 2 subjects discontinued placebo due to consent withdrawn or adverse event.
Outcome measures
| Measure |
MOD-4023
n=125 Participants
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
n=56 Participants
Placebo: Once weekly administration of placebo
|
|---|---|---|
|
Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks
% Change from baseline in week 52
|
-1.6 percentage of change from baseline
Standard Deviation 3.1
|
-1.2 percentage of change from baseline
Standard Deviation 2.8
|
|
Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks
% Change from baseline in week 26
|
-2.4 percentage of change from baseline
Standard Deviation 8.5
|
0.8 percentage of change from baseline
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline to 26 weeksOutcome measures
| Measure |
MOD-4023
n=126 Participants
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
n=56 Participants
Placebo: Once weekly administration of placebo
|
|---|---|---|
|
Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26
|
-1.8 percentage of change from baseline
Standard Deviation 3.0
|
0.6 percentage of change from baseline
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline to 26 weeksOutcome measures
| Measure |
MOD-4023
n=131 Participants
MOD-4023: Individualized once weekly dose of MOD-4023
|
Placebo
n=59 Participants
Placebo: Once weekly administration of placebo
|
|---|---|---|
|
Change in Biochemical Marker IGF-1
|
134.1 ug/L
Standard Deviation 42.4
|
54.5 ug/L
Standard Deviation 29.2
|
Adverse Events
MOD-4023 Period 1
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo Period 1
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
MOD-4023 Period 2 (Treatment Assignments at Period 1)
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo Period 2 (Treatment Assignments at Period 1)
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
MOD-4023 Period 3 (Treatment Assignments at Period 1)
Serious events: 10 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo Period 3 (Treatment Assignments at Period 1)
Serious events: 8 serious events
Other events: 30 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MOD-4023 Period 1
n=133 participants at risk
MOD-4023: Individualized once weekly dose of MOD-4023 (Period 1)
|
Placebo Period 1
n=65 participants at risk
Placebo: Once weekly administration of placebo (Period 1. Only till week 26). Open label once weekly dose of MOD-4023 thereafter
|
MOD-4023 Period 2 (Treatment Assignments at Period 1)
n=133 participants at risk
MOD-4023: Individualized once weekly dose of MOD-4023 (Period 2)
|
Placebo Period 2 (Treatment Assignments at Period 1)
n=65 participants at risk
Placebo assigned and treated in Period 1. Open-label MOD-4023 treatment in Periods 2 and 3
|
MOD-4023 Period 3 (Treatment Assignments at Period 1)
n=111 participants at risk
MOD-4023: Individualized once weekly dose of MOD-4023 (Period 3).
Period 3 was a long-term open label extension
|
Placebo Period 3 (Treatment Assignments at Period 1)
n=50 participants at risk
Placebo assigned and treated in Period 1. Open-label MOD-4023 treatment in Periods 2 and 3
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
1.5%
1/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
1.5%
1/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
1.5%
1/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
1.5%
1/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
1.5%
1/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Nervous system disorders
Dizziness
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
1.5%
1/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
General disorders
Asthenia
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
General disorders
Oedema peripheral
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Bronchitis
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
1.5%
1/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.75%
1/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
1.5%
1/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
1.5%
1/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Appendicitis
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.0%
1/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.0%
1/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Pneumonia
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.0%
1/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.0%
1/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.0%
1/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.0%
1/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Endocrine disorders
Pituitary-dependent Cushing's syndrom
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.0%
1/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.0%
1/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Nervous system disorders
Hemianopia heteronymous
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
General disorders
Pyrexia
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.0%
1/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Product Issues
Device loosening
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.90%
1/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
Other adverse events
| Measure |
MOD-4023 Period 1
n=133 participants at risk
MOD-4023: Individualized once weekly dose of MOD-4023 (Period 1)
|
Placebo Period 1
n=65 participants at risk
Placebo: Once weekly administration of placebo (Period 1. Only till week 26). Open label once weekly dose of MOD-4023 thereafter
|
MOD-4023 Period 2 (Treatment Assignments at Period 1)
n=133 participants at risk
MOD-4023: Individualized once weekly dose of MOD-4023 (Period 2)
|
Placebo Period 2 (Treatment Assignments at Period 1)
n=65 participants at risk
Placebo assigned and treated in Period 1. Open-label MOD-4023 treatment in Periods 2 and 3
|
MOD-4023 Period 3 (Treatment Assignments at Period 1)
n=111 participants at risk
MOD-4023: Individualized once weekly dose of MOD-4023 (Period 3).
Period 3 was a long-term open label extension
|
Placebo Period 3 (Treatment Assignments at Period 1)
n=50 participants at risk
Placebo assigned and treated in Period 1. Open-label MOD-4023 treatment in Periods 2 and 3
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
9.0%
12/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
13.8%
9/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
3.0%
4/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.2%
4/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
3.6%
4/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
8.0%
4/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
5/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
7.7%
5/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
7.5%
10/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.2%
4/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
11.7%
13/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
10.0%
5/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
6/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.2%
4/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
9.0%
10/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.0%
3/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
2/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.2%
4/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Nervous system disorders
Headache
|
8.3%
11/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
7.7%
5/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
8.3%
11/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
3.1%
2/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.3%
7/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
8.0%
4/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.3%
3/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
9.2%
6/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
2.7%
3/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
10.0%
5/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Sinusitis
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
3.6%
4/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
10.0%
5/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Infections and infestations
Bronchitis
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
3.6%
4/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.0%
3/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
General disorders
Pyrexia
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.3%
7/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
4.0%
2/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.0%
3/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/133 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
0.00%
0/65 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
3.6%
4/111 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
6.0%
3/50 • These events were collected throughout the duration of the study and cumulative to weeks Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, >52 weeks to end of study **up to 2 years**
AEs collected and reported for each period of the study. Period 1, Baseline to 26 weeks Period 2, 26 - 52 weeks Period 3, \>52 weeks to end of study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60