Trial Outcomes & Findings for Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System (NCT NCT03959423)
NCT ID: NCT03959423
Last Updated: 2025-01-14
Results Overview
The overall mean difference of the change in HbA1c from baseline to end of 3-month Study Period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
288 participants
Primary outcome timeframe
Baseline to End of 3-Month Study Period
Results posted on
2025-01-14
Participant Flow
329 subjects (179 with age 7-17 and 150 with age 18-75) enrolled at the beginning, with 25 (10 with age 7-17 and 15 with age 18-75) screen failure, 15 subjects (8 with age 7-17 and 7 with age 18-75) early withdrawn, and 1 subject (age 7-17) who never used AHCL, 288 subjects (160 with age 7-17 and 128 with age 18-75) were left as the Intention to Treat Population and started the study. After completing the study, 207 (130 with age 7-17 and 77 with age 18-75) entered the Continued Access Period
Participant milestones
| Measure |
Subjects 7-17 Years of Age
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
128
|
|
Overall Study
COMPLETED
|
151
|
124
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Subjects 7-17 Years of Age
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Parent/Guardian
|
6
|
0
|
Baseline Characteristics
Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System
Baseline characteristics by cohort
| Measure |
Subjects 7-17 Years of Age
n=160 Participants
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age
n=128 Participants
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.3 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
25.6 years
STANDARD_DEVIATION 19.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
144 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
BMI
|
19.7 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 5.6 • n=7 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of 3-Month Study PeriodPopulation: Intention to Treat Population with available data. Twenty-four subjects aged 7-17 and one subject aged 18-75 did not collect A1C at the end of the study period, so 136 subjects aged 7-17 and 127 subjects aged 18-75 were analyzed at end of study period and the change from baseline to end of study period.
The overall mean difference of the change in HbA1c from baseline to end of 3-month Study Period.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=160 Participants
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age
n=128 Participants
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
|---|---|---|
|
Change in HbA1c
Baseline
|
7.9 percentage
Standard Deviation 0.9
|
7.4 percentage
Standard Deviation 0.8
|
|
Change in HbA1c
End of Study
|
7.4 percentage
Standard Deviation 0.7
|
6.9 percentage
Standard Deviation 0.5
|
|
Change in HbA1c
Change from Baseline to End of Study
|
-0.5 percentage
Standard Deviation 0.7
|
-0.5 percentage
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Baseline to End of 3-Month Study PeriodPopulation: Intention to Treat Population
The overall mean change in % of time in euglycemia (70-180 mg/dL) from baseline to end of 3-month Study Period will be estimated.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=160 Participants
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age
n=128 Participants
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
|---|---|---|
|
Change in Percentage of Euglycemia
Baseline
|
59.4 percentage
Standard Deviation 11.8
|
70.5 percentage
Standard Deviation 9.8
|
|
Change in Percentage of Euglycemia
3 Months Study Period
|
70.3 percentage
Standard Deviation 6.5
|
75.0 percentage
Standard Deviation 7.2
|
|
Change in Percentage of Euglycemia
Change from Baseline to 3 Months Study Period
|
11.0 percentage
Standard Deviation 9.1
|
4.6 percentage
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 3-month Study PeriodPopulation: Intention to Treat Population
Number of severe hypoglycemic events occurred during 3-month Study Period
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=160 Participants
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age
n=128 Participants
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
|---|---|---|
|
Number of Severe Hypoglycemic Event
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: 3-month Study PeriodPopulation: Intention to Treat Population
Number of Diabetic Ketoacidosis (DKA) event occurred during 3-month Study Period
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=160 Participants
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age
n=128 Participants
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
|---|---|---|
|
Number of Diabetic Ketoacidosis (DKA) Event
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Baseline to End of 3-Month Study PeriodPopulation: Intention to Treat Population
The overall mean change in % of time in hypoglycemic range (\<70 mg/dL) from baseline to end of 3-month Study Period will be estimated.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=160 Participants
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age
n=128 Participants
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
|---|---|---|
|
Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)
Baseline
|
2.7 percentage
Standard Deviation 2.0
|
3.4 percentage
Standard Deviation 3.0
|
|
Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)
3 Months Study Period
|
2.7 percentage
Standard Deviation 1.6
|
2.3 percentage
Standard Deviation 1.7
|
|
Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)
Change from Baseline to 3 Months Study Period
|
-0.0 percentage
Standard Deviation 1.7
|
-1.0 percentage
Standard Deviation 2.2
|
Adverse Events
Subjects 7-17 Years of Age Study Period
Serious events: 1 serious events
Other events: 72 other events
Deaths: 0 deaths
Subjects 18-75 Years of Age Study Period
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Subjects 7-17 Years of Age Continued Access Phase
Serious events: 3 serious events
Other events: 99 other events
Deaths: 0 deaths
Subjects 18-75 Years of Age Continued Access Phase
Serious events: 8 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects 7-17 Years of Age Study Period
n=160 participants at risk
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age Study Period
n=128 participants at risk
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 7-17 Years of Age Continued Access Phase
n=130 participants at risk
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Continued Access Phase
|
Subjects 18-75 Years of Age Continued Access Phase
n=77 participants at risk
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Continued Access Phase
|
|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Appendicitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Dehydration
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
Other adverse events
| Measure |
Subjects 7-17 Years of Age Study Period
n=160 participants at risk
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 18-75 Years of Age Study Period
n=128 participants at risk
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Study Period
|
Subjects 7-17 Years of Age Continued Access Phase
n=130 participants at risk
Subjects 7-17 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Continued Access Phase
|
Subjects 18-75 Years of Age Continued Access Phase
n=77 participants at risk
Subjects 18-75 years of age wearing Advanced Hybrid Closed Loop pump system and using AHCL during Continued Access Phase
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Cardiac disorders
Palpitations
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Ear and labyrinth disorders
Ear pain
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Endocrine disorders
Goitre
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Endocrine disorders
Growth hormone deficiency
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Endocrine disorders
Primary hyperthyroidism
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Eye disorders
Cataract
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Eye disorders
Chalazion
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Eye disorders
Non-proliferative retinopathy
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Eye disorders
Retinopathy
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Abdominal pain
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
3.1%
4/130 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Constipation
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
3.9%
3/77 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Malpositioned teeth
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Nausea
|
1.2%
2/160 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
2.3%
3/130 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Asthenia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Chest pain
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Extravasation
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Influenza like illness
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Infusion site irritation
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Mass
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Medical device site bruise
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Medical device site dermatitis
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Medical device site erosion
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Medical device site erythema
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Medical device site haemorrhage
|
1.2%
2/160 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Medical device site irritation
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Medical device site pruritus
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Medical device site rash
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
1.6%
2/128 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Oedema peripheral
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
General disorders
Pyrexia
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
2.3%
3/130 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Immune system disorders
Seasonal allergy
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Abscess limb
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Bronchitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
COVID-19
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
26.9%
35/130 • Number of events 42 • 3-month Study Period and 42-month Continued Access Phase
|
42.9%
33/77 • Number of events 38 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Cellulitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Ear infection
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Gastroenteritis
|
3.8%
6/160 • Number of events 6 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
7.7%
10/130 • Number of events 11 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Gastroenteritis viral
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
2.3%
3/130 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
5.2%
4/77 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Gingivitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Herpes simplex
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Hordeolum
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Impetigo
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Infected bite
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Influenza
|
4.4%
7/160 • Number of events 7 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
5.4%
7/130 • Number of events 7 • 3-month Study Period and 42-month Continued Access Phase
|
5.2%
4/77 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Infusion site abscess
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Infusion site infection
|
0.62%
1/160 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Kidney infection
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Localised infection
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Medical device site abscess
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Medical device site cellulitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Medical device site infection
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
3.1%
4/130 • Number of events 5 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
5/160 • Number of events 5 • 3-month Study Period and 42-month Continued Access Phase
|
3.1%
4/128 • Number of events 5 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 5 • 3-month Study Period and 42-month Continued Access Phase
|
3.9%
3/77 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Oral infection
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Otitis externa
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Otitis media
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
3.1%
4/130 • Number of events 5 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Otitis media acute
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Paronychia
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
2.3%
3/130 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
3.8%
5/130 • Number of events 5 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
3.1%
4/130 • Number of events 6 • 3-month Study Period and 42-month Continued Access Phase
|
5.2%
4/77 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Pitted keratolysis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Respiratory tract infection
|
0.62%
1/160 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Rhinitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Sinusitis
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
3.1%
4/128 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
3.1%
4/130 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
7.8%
6/77 • Number of events 7 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Tooth infection
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
7/160 • Number of events 8 • 3-month Study Period and 42-month Continued Access Phase
|
4.7%
6/128 • Number of events 6 • 3-month Study Period and 42-month Continued Access Phase
|
15.4%
20/130 • Number of events 28 • 3-month Study Period and 42-month Continued Access Phase
|
16.9%
13/77 • Number of events 14 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Viral infection
|
5.0%
8/160 • Number of events 9 • 3-month Study Period and 42-month Continued Access Phase
|
1.6%
2/128 • Number of events 5 • 3-month Study Period and 42-month Continued Access Phase
|
8.5%
11/130 • Number of events 13 • 3-month Study Period and 42-month Continued Access Phase
|
3.9%
3/77 • Number of events 7 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.5%
4/160 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
1.6%
2/128 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
5.4%
7/130 • Number of events 9 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Concussion
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Contusion
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Eye abrasion
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Hypobarism
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Incision site vesicles
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.6%
2/128 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
4.6%
6/130 • Number of events 6 • 3-month Study Period and 42-month Continued Access Phase
|
5.2%
4/77 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Poisoning deliberate
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.2%
2/160 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
1.6%
2/128 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Spinal cord injury sacral
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.2%
2/160 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Investigations
Colonoscopy
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Investigations
Hepatobiliary scan
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Acetonaemia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
4.6%
6/130 • Number of events 9 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.1%
29/160 • Number of events 31 • 3-month Study Period and 42-month Continued Access Phase
|
1.6%
2/128 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
36.2%
47/130 • Number of events 114 • 3-month Study Period and 42-month Continued Access Phase
|
16.9%
13/77 • Number of events 18 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Ketosis
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
2.3%
3/130 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
3.1%
4/130 • Number of events 5 • 3-month Study Period and 42-month Continued Access Phase
|
3.9%
3/77 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
5.2%
4/77 • Number of events 5 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Short stature
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Dizziness
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Headache
|
1.9%
3/160 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
1.6%
2/128 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Migraine
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Notalgia paraesthetica
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Presyncope
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Sciatica
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Nervous system disorders
Syncope
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Product Issues
Device issue
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Psychiatric disorders
Depression
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
|
Psychiatric disorders
Major depression
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Psychiatric disorders
Tic
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Reproductive system and breast disorders
Breast discharge
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Reproductive system and breast disorders
Prepuce redundant
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
3/160 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
2.3%
3/130 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
3.1%
4/130 • Number of events 4 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 3 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
1.5%
2/130 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.62%
1/160 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Social circumstances
Ex-tobacco user
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
2.6%
2/77 • Number of events 2 • 3-month Study Period and 42-month Continued Access Phase
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Surgical and medical procedures
Meniscus operation
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Surgical and medical procedures
Nail operation
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Surgical and medical procedures
Tendon sheath incision
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.77%
1/130 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Vascular disorders
Hot flush
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.78%
1/128 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/77 • 3-month Study Period and 42-month Continued Access Phase
|
|
Vascular disorders
Hypertension
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/160 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/128 • 3-month Study Period and 42-month Continued Access Phase
|
0.00%
0/130 • 3-month Study Period and 42-month Continued Access Phase
|
1.3%
1/77 • Number of events 1 • 3-month Study Period and 42-month Continued Access Phase
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60