Trial Outcomes & Findings for 3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) (NCT NCT04144413)
NCT ID: NCT04144413
Last Updated: 2024-08-28
Results Overview
For analysis, SCC (Spearman Correlation Coefficient) and its 95% Confidence Interval were calculated for the correlation analysis between change from baseline in CFS (Corneal Fluorescein Staining) score at visit X and SANDE (Symptom Assessment iN Dry Eye) symptoms score using the FAS (Full Analysis Set) Period 1 Population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
Months 3, 6, 9, and 12
Results posted on
2024-08-28
Participant Flow
Participant milestones
| Measure |
Period 1 Open-Label Treatment Ikervis
Period 1 for all patients: IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Baseline for the first 12 months of treatment.
Open-Label Ikervis: NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
|
Period 2 Masked Treatment Ikervis
Period 2 for markedly improved patients at Month 12 only, and double-masked fashion.
IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36.
Masked Ikervis: NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
|
Period 2 Masked Treatment Vehicle
Other: Vehicle Comparator. Period 2 for markedly improved patients at Month 12 only, and double-masked fashion.
Vehicle: Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36.
Vehicle Comparator is Masked Vehicle: Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.
|
|---|---|---|---|
|
Period 1: Open-Label Treatment Phase
STARTED
|
350
|
0
|
0
|
|
Period 1: Open-Label Treatment Phase
COMPLETED
|
288
|
0
|
0
|
|
Period 1: Open-Label Treatment Phase
NOT COMPLETED
|
62
|
0
|
0
|
|
Period 2: Masked Treatment Phase
STARTED
|
0
|
148
|
97
|
|
Period 2: Masked Treatment Phase
COMPLETED
|
0
|
137
|
86
|
|
Period 2: Masked Treatment Phase
NOT COMPLETED
|
0
|
11
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)
Baseline characteristics by cohort
| Measure |
Period 1 Open-Label Treatment Ikervis
n=350 Participants
Period 1 for all patients: IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Baseline for the first 12 months of treatment.
Open-Label Ikervis: NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
209 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
141 Participants
n=5 Participants
|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
302 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
298 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
331 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
83 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
57 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Months 3, 6, 9, and 12Population: Full Analysis Set (FAS). The number of analyzed data are participants evaluable for the outcome measure at Months 3, 6, 9, and 12. Comment3: Overall Number of Participants analyzed were 336 who received at least one dose of the study medication and had at least one post-baseline sign or symptom assessment of the study eye during Period 1. However, the discrepancy between each specific time-frame is due to missing data or patients withdrawn. These statistical methods were defined in a SAP.
For analysis, SCC (Spearman Correlation Coefficient) and its 95% Confidence Interval were calculated for the correlation analysis between change from baseline in CFS (Corneal Fluorescein Staining) score at visit X and SANDE (Symptom Assessment iN Dry Eye) symptoms score using the FAS (Full Analysis Set) Period 1 Population.
Outcome measures
| Measure |
Period 1 Open-Label Treatment Ikervis
n=336 Participants
Period 1 for all patients: IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Baseline for the first 12 months of treatment.
Open-Label Ikervis: NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
|
|---|---|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 3 / Month 3
|
0.169 Spearman Correlation Coefficient
Interval 0.06 to 0.274
|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 3 / Month 6
|
0.245 Spearman Correlation Coefficient
Interval 0.13 to 0.353
|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 3 / Month 9
|
0.274 Spearman Correlation Coefficient
Interval 0.16 to 0.38
|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 3 / Month 12
|
0.178 Spearman Correlation Coefficient
Interval 0.06 to 0.29
|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 6 / Month 6
|
0.258 Spearman Correlation Coefficient
Interval 0.144 to 0.365
|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 6 / Month 9
|
0.322 Spearman Correlation Coefficient
Interval 0.209 to 0.426
|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 6 / Month 12
|
0.274 Spearman Correlation Coefficient
Interval 0.158 to 0.382
|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 9 / Month 9
|
0.343 Spearman Correlation Coefficient
Interval 0.234 to 0.444
|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 9 / Month 12
|
0.332 Spearman Correlation Coefficient
Interval 0.221 to 0.434
|
|
The Correlation Between Mean Change From Baseline in Corneal Fluorescein Staining (CFS) Score and Symptom Assessment iN Dry Eye (SANDE) Symptoms Score at Each Visit.
Month 12 / Month 12
|
0.266 Spearman Correlation Coefficient
Interval 0.155 to 0.37
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9 and 12Population: Full Analysis Set (FAS). The number of analyzed data are participants evaluable for the outcome measure at Baseline, Months 3, 6, 9, and 12.
Period 1 is Baseline to Month 12 included. CFS is Corneal Fluorescein Score. Staining using fluorescein was graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 per area \[cornea + nasal and temporal conjunctiva\]) for cornea and conjunctiva separately. On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 corresponds to one staining dot per area. A CFS grade of 0 represents complete corneal clearing.
Outcome measures
| Measure |
Period 1 Open-Label Treatment Ikervis
n=336 Participants
Period 1 for all patients: IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Baseline for the first 12 months of treatment.
Open-Label Ikervis: NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
|
|---|---|
|
Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Month 3 change from baseline
|
-1.38 score on a scale
Standard Deviation 0.995
|
|
Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Observed Baseline
|
3.62 score on a scale
Standard Deviation 0.667
|
|
Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Observed Month 3
|
2.24 score on a scale
Standard Deviation 1.072
|
|
Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Observed Month 6
|
1.72 score on a scale
Standard Deviation 1.137
|
|
Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Month 6 change from baseline
|
-1.91 score on a scale
Standard Deviation 1.143
|
|
Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Observed Month 9
|
1.42 score on a scale
Standard Deviation 1.094
|
|
Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Month 9 change from baseline
|
-2.20 score on a scale
Standard Deviation 1.123
|
|
Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Observed Month 12
|
1.14 score on a scale
Standard Deviation 1.008
|
|
Corneal Fluorescein Staining (CFS) Score and Change From Baseline by Visit
Month 12 change from baseline
|
-2.49 score on a scale
Standard Deviation 0.981
|
Adverse Events
Period 1 Open-Label Treatment Ikervis
Serious events: 15 serious events
Other events: 138 other events
Deaths: 1 deaths
Period 2 Masked Treatment Ikervis
Serious events: 12 serious events
Other events: 58 other events
Deaths: 0 deaths
Period 2 Masked Treatment Vehicle
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1 Open-Label Treatment Ikervis
n=344 participants at risk
Period 1 for all patients: IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Baseline for the first 12 months of treatment.
Open-Label Ikervis: NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
Comment 4: The number of enrolled participants were 350, however, 344 participants received at least 1 dose of study medication and were included in the Safety Population Entire Study analysis. Participants who didn't receive study medicaiton were not included in the safety population. These statistical methods were defined in a pre-created statistical analysis plan.
|
Period 2 Masked Treatment Ikervis
n=148 participants at risk
Period 2 for markedly improved patients at Month 12 only, and double-masked fashion.
IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36.
Masked Ikervis: NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
|
Period 2 Masked Treatment Vehicle
n=97 participants at risk
Other: Vehicle Comparator. Period 2 for markedly improved patients at Month 12 only, and double-masked fashion.
Vehicle: Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36.
Vehicle Comparator is Masked Vehicle: Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.2%
4/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Pneumonia
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Wound infection
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Brain Stem Stroke
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Vascular disorders
Hypertensive crisis
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Ear and labyrinth disorders
Vertigo
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Gastrointestinal disorders
Nausea
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.29%
1/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Cataract
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
Other adverse events
| Measure |
Period 1 Open-Label Treatment Ikervis
n=344 participants at risk
Period 1 for all patients: IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Baseline for the first 12 months of treatment.
Open-Label Ikervis: NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
Comment 4: The number of enrolled participants were 350, however, 344 participants received at least 1 dose of study medication and were included in the Safety Population Entire Study analysis. Participants who didn't receive study medicaiton were not included in the safety population. These statistical methods were defined in a pre-created statistical analysis plan.
|
Period 2 Masked Treatment Ikervis
n=148 participants at risk
Period 2 for markedly improved patients at Month 12 only, and double-masked fashion.
IKERVIS® (1mg/ml CsA). Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36.
Masked Ikervis: NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
|
Period 2 Masked Treatment Vehicle
n=97 participants at risk
Other: Vehicle Comparator. Period 2 for markedly improved patients at Month 12 only, and double-masked fashion.
Vehicle: Instillation of one drop in each affected eye, once daily at bedtime. From Month 12 to Month 36.
Vehicle Comparator is Masked Vehicle: Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.
|
|---|---|---|---|
|
Eye disorders
Eye irritation
|
7.6%
26/344 • Number of events 28 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.7%
4/148 • Number of events 4 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Eye pain
|
4.7%
16/344 • Number of events 18 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.1%
2/97 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Dry Eye
|
4.4%
15/344 • Number of events 15 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.0%
3/148 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
5.2%
5/97 • Number of events 5 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Eye pruritus
|
3.5%
12/344 • Number of events 12 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.0%
3/148 • Number of events 4 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Ocular hyperaemia
|
3.2%
11/344 • Number of events 11 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.0%
3/148 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Visual acuity reduced
|
1.2%
4/344 • Number of events 5 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.0%
3/148 • Number of events 4 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
3.1%
3/97 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Conjunctival hyperaemia
|
1.2%
4/344 • Number of events 4 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.1%
2/97 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Lacrimation increased
|
0.87%
3/344 • Number of events 4 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Vision blurred
|
1.2%
4/344 • Number of events 4 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.0%
3/148 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Abnormal sensation in eye
|
0.87%
3/344 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Chalazion
|
0.87%
3/344 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.1%
2/97 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Conjunctival oedema
|
0.87%
3/344 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Ocular discomfort
|
0.87%
3/344 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Blepharospasm
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Corneal leukoma
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Corneal oedema
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Eyelid oedema
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Eyelids pruritus
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.0%
3/148 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.1%
2/97 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Keratitis
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.1%
2/97 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Lenticular opacities
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Noninfective conjunctivitis
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Blepharitis
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
3.4%
5/148 • Number of events 5 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
3.1%
3/97 • Number of events 5 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Cataract
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
3.4%
5/148 • Number of events 6 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Conjunctivitis allergic
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Dacryolith
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Dermatochalasis
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Eczema eyelids
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Erythema of eyelid
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Lacrimation disorder
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Ocular hypertension
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Pinguecula
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
COVID-19
|
2.3%
8/344 • Number of events 8 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
6.8%
10/148 • Number of events 11 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
5.2%
5/97 • Number of events 5 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Conjunctivitis
|
1.2%
4/344 • Number of events 5 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.0%
3/148 • Number of events 4 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.1%
2/97 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Nasopharyngitis
|
0.87%
3/344 • Number of events 4 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Hordeolum
|
0.87%
3/344 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Bronchitis
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Herpes zoster
|
0.29%
1/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Viral infection
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Eye infection viral
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Eyelid infection
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Influenza
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Respiratory tract infection
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Rhinitis
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Tooth abscess
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Wound infection
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
4/344 • Number of events 4 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
General disorders
Instillation site pain
|
0.87%
3/344 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
General disorders
Fatigue
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
General disorders
Instillation site paraesthesia
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
General disorders
Oedema peripheral
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
General disorders
Product intolerance
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
General disorders
Pyrexia
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Gastrointestinal disorders
Food poisoning
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Gastrointestinal disorders
Nausea
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Gastrointestinal disorders
Stomatitis
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Facial paralysis
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Dizziness
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Facial neuralgia
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Headache
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Migraine
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Migraine with aura
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Nervous system disorders
Somnolence
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Soft tissue foreign body
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Cardiac disorders
Arrhythmia
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Cardiac disorders
Atrial fibrillation
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Immune system disorders
Hypersensitivity
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Immune system disorders
Seasonal allergy
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Vascular disorders
Lymphoedema
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Vascular disorders
Varicose ulceration
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Investigations
Blood cholesterol
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Investigations
Blood pressure decreased
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Psychiatric disorders
Anxiety
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Psychiatric disorders
Depression
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Endocrine disorders
Hypothyroidism
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.29%
1/344 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Photophobia
|
0.58%
2/344 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.0%
3/148 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.1%
2/97 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Diplopia
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Episcleritis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Eye allergy
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Meibomianitis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Eyelash discolouration
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Macular cyst
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Meibomian gland discharge
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Photopsia
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Trichiasis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Varicella
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Parotitis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Meniscal degeneration
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Surgical and medical procedures
Lens extraction
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Surgical and medical procedures
Foot operation
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 2 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Investigations
Body temperature increased
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Investigations
Vital dye staining cornea present
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
General disorders
Discomfort
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid haemangioma
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal lymphoma
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord inflammation
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.68%
1/148 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/97 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Vascular disorders
Hypertension
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
0.00%
0/148 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
|
Eye disorders
Lacrimal disorder
|
0.00%
0/344 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
1.4%
2/148 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
2.1%
2/97 • Number of events 3 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both Period 1 (Open-Label Treatment Period) at Month 12 and Period 2 (Double Masked Treatment Period) at Month 36.
Other Adverse Events data is a summary observed at a rate of 0% or higher by System Organ Class and Preferred Term for both the Open-Label and Double Masked Periods. The summary of other adverse events in Open Label Treatment Period and Double Masked Treatment Period are independently summarized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place