Trial Outcomes & Findings for A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® (NCT NCT05405725)
NCT ID: NCT05405725
Last Updated: 2026-02-10
Results Overview
The percentage change in BMD at lumbar spine (L1-L4 region) measured by DXA from baseline to month 12 and the mean (±SD) percentage change over time is displayed for the ITT set. The ITT analysis set consisted of all randomised participants who received at least one dose of study intervention in the double-blind treatment period. In the ITT analysis set, treatment was assigned based on the study intervention to which participants were randomised, regardless of which treatment they actually received.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
504 participants
Primary outcome timeframe
Month 12
Results posted on
2026-02-10
Participant Flow
A total of 504 participants were randomized in the study at 44 centers across 7 countries (Bulgaria, Czech Republic, Denmark, Lithuania, Poland, Spain and Serbia) between July 2022 and January 2023.
The study included a Screening Period of maximum 35 days prior to first drug (ENZ215 and Prolia) administration, a double-blind Treatment Period up to Week 52, and an open label switchover treatment period for a subset of 120 participants from Prolia group, with administration of the study drug on Day 1, Week 26, and Week 52.
Participant milestones
| Measure |
Prolia
Prolia Injection:- 60 mg denosumab administered as a single subcutaneous injection at Day 1 and at 6 months
|
Prolia + ENZ215
A subset of 120 patients initially randomized to Prolia® arm re-randomized in a 1:1 ratio (i.e. 60 patients in each arm) in an open-label switch-over period to receive either ENZ215 or Prolia® (60 mg) SC at Month 12 in order to assess the impact on immunogenicity and safety of switching patients from Prolia® to ENZ215.
|
Prolia + Prolia
A subset of 120 patients initially randomized to Prolia® arm re-randomized in a 1:1 ratio (i.e. 60 patients in each arm) in an open-label switch-over period to receive either ENZ215 or Prolia® (60 mg) SC at Month 12 in order to assess the impact on immunogenicity and safety of switching patients from Prolia® to ENZ215.
|
ENZ215
ENZ215 Injection: - 60 mg denosumab administered as a single subcutaneous injection at Day 1 and at month 6
|
|---|---|---|---|---|
|
Double-blind Treatment Period
STARTED
|
251
|
0
|
0
|
253
|
|
Double-blind Treatment Period
COMPLETED
|
236
|
0
|
0
|
233
|
|
Double-blind Treatment Period
NOT COMPLETED
|
15
|
0
|
0
|
20
|
|
Open-label Switchover Period
STARTED
|
0
|
60
|
60
|
0
|
|
Open-label Switchover Period
COMPLETED
|
0
|
60
|
60
|
0
|
|
Open-label Switchover Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®
Baseline characteristics by cohort
| Measure |
ENZ215
n=253 Participants
ENZ215 Injection:- 60 mg denosumab administered as a single subcutaneous injection once every 6 months
|
Prolia
n=251 Participants
Prolia Injection:- 60 mg denosumab administered as a single subcutaneous injection at Day 1 and at month 6
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
171 Participants
n=41 Participants
|
171 Participants
n=1581 Participants
|
342 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
82 Participants
n=41 Participants
|
80 Participants
n=1581 Participants
|
162 Participants
n=4626 Participants
|
|
Sex: Female, Male
Female
|
253 Participants
n=41 Participants
|
251 Participants
n=1581 Participants
|
504 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
253 Participants
n=41 Participants
|
251 Participants
n=1581 Participants
|
504 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: The ITT analysis set consisted of all randomised participants who received at least one dose of study intervention in the double-blind treatment period. In the ITT analysis set, treatment was assigned based on the study intervention to which participants were randomised, regardless of which treatment they actually received.
The percentage change in BMD at lumbar spine (L1-L4 region) measured by DXA from baseline to month 12 and the mean (±SD) percentage change over time is displayed for the ITT set. The ITT analysis set consisted of all randomised participants who received at least one dose of study intervention in the double-blind treatment period. In the ITT analysis set, treatment was assigned based on the study intervention to which participants were randomised, regardless of which treatment they actually received.
Outcome measures
| Measure |
ENZ215
n=231 Participants
ENZ215 Injection:- 60 mg Denosumab (ENZ215) administered subcutaneously on day 1 and Month 6
|
Prolia
n=235 Participants
Prolia Injection:- 60 mg Denosumab (Prolia) administered subcutaneously on day 1 and at month 6.
|
Prolia + ENZ215
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive ENZ215 (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
Prolia + Prolia
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive Prolia (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
|---|---|---|---|---|
|
To Evaluate the Efficacy of ENZ215 When Compared to Prolia in Patients With Postmenopausal Osteoporosis, in Terms of Change in Bone Mineral Density (BMD) at Lumbar Spine.
|
5.350 % Change from Baseline
Standard Error 0.3152
|
5.533 % Change from Baseline
Standard Error 0.3108
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 6Population: The analysis was performed on the PD Set. The PD Set consisted of all participants in the Safety Set whose sCTX values were available in order to calculate PD parameter AUEC values for primary analysis and had no major protocol deviations which affected sCTX measurement.
The AUEC of %CfB in sCTX of ENZ215 was assessed as part of pharmacodynamics assessment to compare with Prolia® in female participants with postmenopausal osteoporosis. This outcome measure was assessed for initial 6 months
Outcome measures
| Measure |
ENZ215
n=234 Participants
ENZ215 Injection:- 60 mg Denosumab (ENZ215) administered subcutaneously on day 1 and Month 6
|
Prolia
n=237 Participants
Prolia Injection:- 60 mg Denosumab (Prolia) administered subcutaneously on day 1 and at month 6.
|
Prolia + ENZ215
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive ENZ215 (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
Prolia + Prolia
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive Prolia (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
|---|---|---|---|---|
|
Area Under the Effect Curve (AUEC) of % Change From Baseline (%CfB) of Serum C-telopeptide of Type-1 Collagen (sCTX) Levels
|
347382.787 h*%
Interval 340087.2488 to 354834.8289
|
345858.423 h*%
Interval 338640.7259 to 352229.9557
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Month 12 for Double blind treatment period and to month 18 for Open label switchover treatment periodPopulation: The analysis was performed on Safety set. The Safety Set included all randomised participants who received at least one dose of study intervention. In the safety set, treatment was assigned based on the actual treatment that participants received.
ADAs incidence such as ADA positive, ADA negative, NAB positive, NAB negative assessed at baseline and different timepoints from 1 month to 12 months and during open-label switch over period assessed. Subjects were considered as post-treatment ADA and NAb positive if they had at least one "Positive" ADA and NAb result after the first drug exposure. Post-treatment ADA and NAb status was determined regardless of the results at pre-dose.
Outcome measures
| Measure |
ENZ215
n=253 Participants
ENZ215 Injection:- 60 mg Denosumab (ENZ215) administered subcutaneously on day 1 and Month 6
|
Prolia
n=251 Participants
Prolia Injection:- 60 mg Denosumab (Prolia) administered subcutaneously on day 1 and at month 6.
|
Prolia + ENZ215
n=60 Participants
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive ENZ215 (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
Prolia + Prolia
n=60 Participants
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive Prolia (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
|---|---|---|---|---|
|
To Compare the Immunogenicity Potential of ENZ215 and Prolia
ADA positive subjects
|
252 Participants
|
247 Participants
|
60 Participants
|
60 Participants
|
|
To Compare the Immunogenicity Potential of ENZ215 and Prolia
nAb positive subjects
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Immunogenicity Potential of ENZ215 and Prolia
ADA Negative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Immunogenicity Potential of ENZ215 and Prolia
Nab Negative
|
251 Participants
|
242 Participants
|
60 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The PK Set was a subset of Safety Set with at least one evaluable PK endpoint (Cmax or AUC0-6M) and no major protocol deviations affecting the PK parameters up to Month 12. All the protocol deviations (irrespective of major / minor protocol deviations) with action for analysis that led to exclusion from PK set were considered for exclusion from PK set in the PK analysis set derivation.
Comparison of PK parameters of ENZ215 and Prolia over 12 months
Outcome measures
| Measure |
ENZ215
n=57 Participants
ENZ215 Injection:- 60 mg Denosumab (ENZ215) administered subcutaneously on day 1 and Month 6
|
Prolia
n=59 Participants
Prolia Injection:- 60 mg Denosumab (Prolia) administered subcutaneously on day 1 and at month 6.
|
Prolia + ENZ215
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive ENZ215 (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
Prolia + Prolia
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive Prolia (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
|---|---|---|---|---|
|
To Compare the Pharmacokinetics of ENZ215 and Prolia
AUC (0-1M)
|
3220000 h*ng/mL
Geometric Coefficient of Variation 40.4
|
3000000 h*ng/mL
Geometric Coefficient of Variation 33.1
|
—
|
—
|
|
To Compare the Pharmacokinetics of ENZ215 and Prolia
AUC (0-3M)
|
7260000 h*ng/mL
Geometric Coefficient of Variation 45.7
|
6450000 h*ng/mL
Geometric Coefficient of Variation 35.2
|
—
|
—
|
|
To Compare the Pharmacokinetics of ENZ215 and Prolia
AUC (0-6M)
|
8420000 h*ng/mL
Geometric Coefficient of Variation 48.0
|
7460000 h*ng/mL
Geometric Coefficient of Variation 36.7
|
—
|
—
|
|
To Compare the Pharmacokinetics of ENZ215 and Prolia
AUC (6-12M)
|
312000 h*ng/mL
Geometric Coefficient of Variation 232.1
|
301000 h*ng/mL
Geometric Coefficient of Variation 130.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: The analysis was performed on PD set. The PD Set consisted of all participants in the Safety Set whose sCTX/P1NP values were available in order to calculate PD parameter AUEC values for primary analysis and had no major protocol deviations which affected sCTX or sP1NP measurement.
Percent change from baseline in type 1 N-terminal propeptide (sP1NP) levels at 6 months
Outcome measures
| Measure |
ENZ215
n=234 Participants
ENZ215 Injection:- 60 mg Denosumab (ENZ215) administered subcutaneously on day 1 and Month 6
|
Prolia
n=237 Participants
Prolia Injection:- 60 mg Denosumab (Prolia) administered subcutaneously on day 1 and at month 6.
|
Prolia + ENZ215
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive ENZ215 (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
Prolia + Prolia
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive Prolia (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
|---|---|---|---|---|
|
Serum Procollagen Type 1 N-terminal Propeptide (sP1NP) Levels
Month 3 (Day 90)
|
-75.7738 Percentage Change from baseline
Standard Deviation 15.4099
|
-74.5419 Percentage Change from baseline
Standard Deviation 16.6630
|
—
|
—
|
|
Serum Procollagen Type 1 N-terminal Propeptide (sP1NP) Levels
Month 1 (Day 15)
|
8.3369 Percentage Change from baseline
Standard Deviation 19.5170
|
7.5198 Percentage Change from baseline
Standard Deviation 17.9673
|
—
|
—
|
|
Serum Procollagen Type 1 N-terminal Propeptide (sP1NP) Levels
Month 1 (Day 30)
|
-17.7485 Percentage Change from baseline
Standard Deviation 17.1910
|
-18.3767 Percentage Change from baseline
Standard Deviation 23.4844
|
—
|
—
|
|
Serum Procollagen Type 1 N-terminal Propeptide (sP1NP) Levels
Month 6 (Day 180)
|
-69.7567 Percentage Change from baseline
Standard Deviation 19.4086
|
-69.1690 Percentage Change from baseline
Standard Deviation 22.8816
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Percentage change in BMD at lumbar spine (L1-L4 region) measured by DXA from baseline to Month 6 for the ENZ215 and Prolia® treatment groups was compared in ITT set. The ITT analysis set consisted of all randomised participants who received at least one dose of study intervention in the double-blind treatment period. The number of subjects with 6 months available assessments have been presented here.
Percentage change in BMD at lumbar spine measured by DXA from baseline at month 6
Outcome measures
| Measure |
ENZ215
n=240 Participants
ENZ215 Injection:- 60 mg Denosumab (ENZ215) administered subcutaneously on day 1 and Month 6
|
Prolia
n=246 Participants
Prolia Injection:- 60 mg Denosumab (Prolia) administered subcutaneously on day 1 and at month 6.
|
Prolia + ENZ215
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive ENZ215 (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
Prolia + Prolia
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive Prolia (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
|---|---|---|---|---|
|
To Compare the Change in BMD at the Lumbar Spine at Month 6
|
3.615 Percentage Change
Standard Error 0.2643
|
4.004 Percentage Change
Standard Error 0.2596
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Month 6 and Month 12Population: The analysis was performed using ITT set. The ITT analysis set consisted of all randomised participants who received at least one dose of study intervention in the double-blind treatment period. In the ITT analysis set, treatment was assigned based on the study intervention to which participants were randomised, regardless of which treatment they actually received. BMD Data excluded from analysis due to major protocol deviation for few of the patients as defined in SAP.
Percentage change in BMD at total hip and femoral neck measured by DXA from baseline to Month to predefined timepoint
Outcome measures
| Measure |
ENZ215
n=240 Participants
ENZ215 Injection:- 60 mg Denosumab (ENZ215) administered subcutaneously on day 1 and Month 6
|
Prolia
n=245 Participants
Prolia Injection:- 60 mg Denosumab (Prolia) administered subcutaneously on day 1 and at month 6.
|
Prolia + ENZ215
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive ENZ215 (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
Prolia + Prolia
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive Prolia (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
|---|---|---|---|---|
|
To Compare the Change in BMD at Total Hip and Femoral Neck
Month 12-BMD at Femoral Neck
|
1.826 Percentage Change
Standard Error 0.2905
|
2.589 Percentage Change
Standard Error 0.2866
|
—
|
—
|
|
To Compare the Change in BMD at Total Hip and Femoral Neck
Month 6-BMD at Femoral Neck
|
1.700 Percentage Change
Standard Error 0.2461
|
1.688 Percentage Change
Standard Error 0.2420
|
—
|
—
|
|
To Compare the Change in BMD at Total Hip and Femoral Neck
Month 12-BMD at Total Hip
|
2.534 Percentage Change
Standard Error 0.2044
|
2.935 Percentage Change
Standard Error 0.2012
|
—
|
—
|
|
To Compare the Change in BMD at Total Hip and Femoral Neck
Month 6-BMD at Total Hip
|
2.222 Percentage Change
Standard Error 0.2042
|
2.327 Percentage Change
Standard Error 0.2005
|
—
|
—
|
Adverse Events
ENZ215
Serious events: 16 serious events
Other events: 115 other events
Deaths: 0 deaths
Prolia
Serious events: 15 serious events
Other events: 122 other events
Deaths: 1 deaths
Prolia + ENZ215
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Prolia + Prolia
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ENZ215
n=253 participants at risk
ENZ215 Injection: - 60 mg denosumab administered as a single subcutaneous injection once every 6 months. These participants completed the study at Month 12.
|
Prolia
n=251 participants at risk
Prolia Injection: - 60 mg denosumab administered as a single subcutaneous injection once every 6 months. These participants completed the study at Month 12.
|
Prolia + ENZ215
n=60 participants at risk
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive ENZ215 (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
Prolia + Prolia
n=60 participants at risk
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and received Prolia® (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Radius Fracture
|
1.2%
3/253 • Number of events 4 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.79%
2/253 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
COVID-19
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Cystitis
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Diverticulitis
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Influenza
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Pneumonia
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chromophobe renal cell carcinoma
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Cardiac disorders
Pericarditis
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Nervous system disorders
Myasthenia gravis
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Nervous system disorders
Thoracic radiculopathy
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Investigations
Red Blood Cell urine positive
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
SAPHO Syndrome
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
Other adverse events
| Measure |
ENZ215
n=253 participants at risk
ENZ215 Injection: - 60 mg denosumab administered as a single subcutaneous injection once every 6 months. These participants completed the study at Month 12.
|
Prolia
n=251 participants at risk
Prolia Injection: - 60 mg denosumab administered as a single subcutaneous injection once every 6 months. These participants completed the study at Month 12.
|
Prolia + ENZ215
n=60 participants at risk
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and receive ENZ215 (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
Prolia + Prolia
n=60 participants at risk
A subset of 60 participants randomised to Prolia arm in double blind treatment arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion were enrolled in the open-label, switch-over extension period and received Prolia® (60 mg) SC at Month 12, these participants completed the study at Month 18.
|
|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
3.6%
9/253 • Number of events 9 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
4.8%
12/251 • Number of events 14 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
General disorders
Fatigue
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.80%
2/251 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Investigations
Vitamin D decreased
|
2.4%
6/253 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
2.4%
6/251 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Nervous system disorders
Headache
|
2.4%
6/253 • Number of events 9 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
5.2%
13/251 • Number of events 16 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Nervous system disorders
Radiculopathy
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
6/253 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
2.4%
6/251 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.79%
2/253 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
2.0%
5/251 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Gastrointestinal disorders
Chronic Gastritis
|
0.79%
2/253 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.2%
3/251 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.80%
2/251 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Gastrointestinal disorders
Toothache
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.80%
2/251 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
5/253 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.2%
3/251 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.2%
8/253 • Number of events 9 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.6%
4/251 • Number of events 4 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
2.0%
5/253 • Number of events 7 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.6%
4/251 • Number of events 4 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
3.3%
2/60 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
9/253 • Number of events 9 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
3.6%
9/251 • Number of events 13 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
6/253 • Number of events 9 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
2.4%
6/251 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.79%
2/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.2%
3/251 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.80%
2/251 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
18/253 • Number of events 21 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
8.8%
22/251 • Number of events 24 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
8.3%
5/60 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
8.3%
5/60 • Number of events 5 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Bronchitis
|
4.3%
11/253 • Number of events 12 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
2.4%
6/251 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
3.3%
2/60 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
COVID-19
|
2.0%
5/253 • Number of events 5 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
4.8%
12/251 • Number of events 12 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Pharyngitis
|
2.4%
6/253 • Number of events 7 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.2%
3/251 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
3.3%
2/60 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.3%
11/253 • Number of events 13 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
6.4%
16/251 • Number of events 19 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
3.3%
2/60 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
5/253 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Sinusitis
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.6%
4/251 • Number of events 4 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Urinary Tract Infection
|
3.2%
8/253 • Number of events 8 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
3.2%
8/251 • Number of events 9 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Cystitis
|
2.0%
5/253 • Number of events 5 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
2.4%
6/251 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Urinary Tract Infection bacterial
|
1.2%
3/253 • Number of events 4 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
2.0%
5/251 • Number of events 5 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
2.0%
5/251 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Oral Herpes
|
0.79%
2/253 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.2%
3/251 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Pulpitis Dental
|
0.40%
1/253 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.2%
3/251 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Bronchitis Bacterial
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
1.2%
3/253 • Number of events 4 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.8%
7/253 • Number of events 7 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
2.4%
6/251 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.4%
6/253 • Number of events 6 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.6%
4/251 • Number of events 4 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.79%
2/253 • Number of events 2 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.6%
4/251 • Number of events 4 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.2%
3/253 • Number of events 3 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.40%
1/251 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Influenza
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Lyme Disease
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Infections and infestations
Viral infection
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Shoulder girdle pain
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Hypomagnesaemia
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Dyslipidaemia
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Hypercholesterolaemia
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Musculoskeletal and connective tissue disorders
Hypertriglyceridaemia
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Eye disorders
Blepharochalasis
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Eye disorders
Chalazion
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Eye disorders
Glaucoma
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of conjunctiva
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/253 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/251 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
1.7%
1/60 • Number of events 1 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
0.00%
0/60 • From Baseline to Month 12 for participants in main study and up to 18 months for participants in Open label switch over period
Any medical condition that is present at the time that the patient is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any abnormal laboratory test results or other safety assessments (e.g., ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place