Trial Outcomes & Findings for An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye (NCT NCT03019627)
NCT ID: NCT03019627
Last Updated: 2019-02-08
Results Overview
Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
week 8
Results posted on
2019-02-08
Participant Flow
After confirmation of inclusion and exclusion criteria all eligible patients were randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up. rhNGF and vehicle were administered as eye drops at 20 μg/mL concentration, six times daily for 8 weeks in patients with dry eye
Participant milestones
| Measure |
rhNGF 20μg/mL
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
50
|
|
Overall Study
COMPLETED
|
85
|
42
|
|
Overall Study
NOT COMPLETED
|
15
|
8
|
Reasons for withdrawal
| Measure |
rhNGF 20μg/mL
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
0
|
|
Overall Study
Unrelated to adverse event
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
not compliance
|
2
|
2
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye
Baseline characteristics by cohort
| Measure |
rhNGF 20μg/mL
n=100 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
n=50 Participants
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 11.89 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 11.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
50 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
Number of baseline participants
|
100 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 8Population: Full analysis set population
Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Outcome measures
| Measure |
rhNGF 20μg/mL
n=97 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
n=48 Participants
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Symptom Assessment in Dry Eye (SANDE) Scores
Frequency
|
-38.8 units on a scale
Standard Deviation 28.97
|
-34.0 units on a scale
Standard Deviation 26.67
|
|
Symptom Assessment in Dry Eye (SANDE) Scores
Severity
|
-32.2 units on a scale
Standard Deviation 31.04
|
-31.07 units on a scale
Standard Deviation 28.32
|
SECONDARY outcome
Timeframe: Week 4, week 8, week 12Population: Full analysis set population
Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Outcome measures
| Measure |
rhNGF 20μg/mL
n=97 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
n=48 Participants
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
SANDE Scores
Severity - week 8
|
-32.6 units on a scale
Standard Deviation 30.64
|
-33.1 units on a scale
Standard Deviation 28.30
|
|
SANDE Scores
Frequency - week 4
|
-22.1 units on a scale
Standard Deviation 24.08
|
-20.4 units on a scale
Standard Deviation 20.66
|
|
SANDE Scores
Frequency - week 8
|
-39.6 units on a scale
Standard Deviation 28.55
|
-34.6 units on a scale
Standard Deviation 27.60
|
|
SANDE Scores
Frequency - week 12
|
-44.8 units on a scale
Standard Deviation 28.69
|
-28.2 units on a scale
Standard Deviation 28.94
|
|
SANDE Scores
Severity - week 4
|
-19.9 units on a scale
Standard Deviation 25.20
|
-22.2 units on a scale
Standard Deviation 24.31
|
|
SANDE Scores
Severity - week 12
|
-38.8 units on a scale
Standard Deviation 29.20
|
-24.3 units on a scale
Standard Deviation 28.43
|
SECONDARY outcome
Timeframe: week 4, week 8, week 12Population: Full analysis set population
Changes from baseline on National Eye Institute (NEI) scale. The NEI/Industry Workshop guidelines were used for grading the scale of corneal and conjunctival damage. The cornea was divided into five sectors (central, superior, inferior, nasal and temporal), each of which was scored on a scale of 0-3, with a maximal total corneal staining score of 15. Both nasally and temporally, the conjunctiva was divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18). Briefly, grade 0 reflected normal/healthy situation, whereas grade 3 reflected a severe damage in the considered sector.
Outcome measures
| Measure |
rhNGF 20μg/mL
n=97 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
n=48 Participants
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Cornea Vital Staining
week 4
|
-3.5 units on a scale
Standard Deviation 2.32
|
-3.0 units on a scale
Standard Deviation 2.27
|
|
Cornea Vital Staining
week 8
|
-4.2 units on a scale
Standard Deviation 2.92
|
-4.4 units on a scale
Standard Deviation 2.70
|
|
Cornea Vital Staining
week 12
|
-4.4 units on a scale
Standard Deviation 2.80
|
-5.1 units on a scale
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: week 4, week 8, week 12Population: Full analysis set population
Changes from baseline on National Eye Institute (NEI) scale. The NEI/Industry Workshop guidelines were used for grading the scale of corneal and conjunctival damage. The cornea was divided into five sectors (central, superior, inferior, nasal and temporal), each of which was scored on a scale of 0-3, with a maximal total corneal staining score of 15. Both nasally and temporally, the conjunctiva was divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18). Briefly, grade 0 reflected normal/healthy situation, whereas grade 3 reflected a severe damage in the considered sector.
Outcome measures
| Measure |
rhNGF 20μg/mL
n=97 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
n=48 Participants
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Conjunctival Vital Staining
week 4
|
-4.7 units on a scale
Standard Deviation 3.94
|
-4.1 units on a scale
Standard Deviation 3.45
|
|
Conjunctival Vital Staining
week 8
|
-6.7 units on a scale
Standard Deviation 4.16
|
-5.9 units on a scale
Standard Deviation 4.07
|
|
Conjunctival Vital Staining
week 12
|
-7.2 units on a scale
Standard Deviation 4.23
|
-7.0 units on a scale
Standard Deviation 3.90
|
SECONDARY outcome
Timeframe: week 4, week 8, week 12Population: Full analysis set population
TFBUT was measured by determining the time to tear break-up. The TFBUT was performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.
Outcome measures
| Measure |
rhNGF 20μg/mL
n=97 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
n=48 Participants
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Change in Tear Film Break-up Time (TFBUT)
week 4
|
0.4 seconds
Standard Deviation 1.68
|
0.8 seconds
Standard Deviation 1.57
|
|
Change in Tear Film Break-up Time (TFBUT)
week 8
|
0.5 seconds
Standard Deviation 1.74
|
0.7 seconds
Standard Deviation 1.89
|
|
Change in Tear Film Break-up Time (TFBUT)
week 12
|
0.5 seconds
Standard Deviation 2.34
|
0.9 seconds
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: week 8Population: Full analysis set population
The Schirmer test without anesthesia was performed to measure aqueous tear secretion prior to the instillation of any dilating or eye drops
Outcome measures
| Measure |
rhNGF 20μg/mL
n=85 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
n=42 Participants
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Change From Baseline in Wetting Distance
|
2.4 millimeters
Standard Deviation 11.41
|
-3.1 millimeters
Standard Deviation 8.66
|
Adverse Events
rhNGF 20μg/mL
Serious events: 5 serious events
Other events: 97 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rhNGF 20μg/mL
n=100 participants at risk
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
n=50 participants at risk
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Infections and infestations
Diverticulitis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
Other adverse events
| Measure |
rhNGF 20μg/mL
n=100 participants at risk
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
NGF: Eye Drop 20 μg/mL
|
Vehicle
n=50 participants at risk
vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Infections and infestations
Pyelonephritis acute
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Ocular discomfort
|
69.0%
69/100 • Number of events 87 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
20.0%
10/50 • Number of events 17 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eye pain
|
42.0%
42/100 • Number of events 67 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
8.0%
4/50 • Number of events 4 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eye irritation
|
15.0%
15/100 • Number of events 19 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
20.0%
10/50 • Number of events 11 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Vision blurred
|
13.0%
13/100 • Number of events 14 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
8.0%
4/50 • Number of events 6 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Photophobia
|
12.0%
12/100 • Number of events 14 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
6.0%
3/50 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eye pruritus
|
8.0%
8/100 • Number of events 8 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
10.0%
5/50 • Number of events 5 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eye discharge
|
9.0%
9/100 • Number of events 13 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eyelid disorder
|
8.0%
8/100 • Number of events 8 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eyelid oedema
|
4.0%
4/100 • Number of events 6 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Dry eye
|
4.0%
4/100 • Number of events 4 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eyelid pain
|
5.0%
5/100 • Number of events 5 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Lacrimation increased
|
3.0%
3/100 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
4.0%
2/50 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Ocular hyperaemia
|
3.0%
3/100 • Number of events 8 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Blepharospasm
|
2.0%
2/100 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
4.0%
2/50 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eye swelling
|
4.0%
4/100 • Number of events 5 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eyelid margin crusting
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Foreign body sensation in eyes
|
3.0%
3/100 • Number of events 4 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Abnormal sensation in eye
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
4.0%
2/50 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eyelid pruritus
|
2.0%
2/100 • Number of events 4 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Asthenopia
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Conjunctival haemorrhage
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Diplopia
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eye allergy
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Scleral haemorrhage
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
visual impairment
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Vitreous floaters
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eye paraesthesia
|
1.0%
1/100 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Conjunctival deposit
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Corneal oedema
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eye inflammation
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eyelid irritation
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Eyelid sensory disorder
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Lacrimation decreased
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Photopsia
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Eye disorders
Scleral discolouration
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Headache
|
12.0%
12/100 • Number of events 14 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
10.0%
5/50 • Number of events 11 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Migrane
|
3.0%
3/100 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Burning sensation
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Paraesthesia
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Autonomic failure syndrome
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Cervical Myelopathy
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Dizziness
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Dysarthria
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Neuralgia
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Polyneuropathy idiopathic progressive
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Sciatica
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Nervous system disorders
Sinus headache
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.0%
8/100 • Number of events 10 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
10.0%
5/50 • Number of events 5 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Sinusitis
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
4.0%
2/50 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Acute sinusitis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Cellulitis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Conjunctivitis viral
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Diverticulitis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Ear infection
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Fungal infection
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Herpes virus infection
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Influenza
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Pertussis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Pharyngitis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Pneumonia
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
3.0%
3/100 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
3/100 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
4.0%
2/50 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
plantar fasciitis
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
6.0%
3/50 • Number of events 8 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
1.0%
1/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
General disorders
Sensation of foreign body
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
General disorders
Pyrexia
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
General disorders
Fatigue
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
General disorders
Generalized oedema
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
General disorders
Humidity intolerance
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
General disorders
Oedema peripheral
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
General disorders
Pain
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
General disorders
Temperature intolerance
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Gastrointestinal disorders
abdominal discomfort
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Gastrointestinal disorders
Diverticulum
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Gastrointestinal disorders
Dry mouth
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Gastrointestinal disorders
Glossodynia
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Gastrointestinal disorders
Salivary gland calculus
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
2.0%
2/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Injury, poisoning and procedural complications
Superficial injury of eye
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Injury, poisoning and procedural complications
Contusion
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Injury, poisoning and procedural complications
Eye burns
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Injury, poisoning and procedural complications
Eye contusion
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Injury, poisoning and procedural complications
Eye injury
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Immune system disorders
Seasonal allergy
|
3.0%
3/100 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Immune system disorders
Hypersensivity
|
1.0%
1/100 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Immune system disorders
Graft versus host disease
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Immune system disorders
Multiple allergies
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Surgical and medical procedures
Endodontic procedure
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Surgical and medical procedures
Eye laser surgery
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Surgical and medical procedures
Haemorrhoid operation
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Surgical and medical procedures
Tooth extraction
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Surgical and medical procedures
Vena cava filter removal
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Psychiatric disorders
Panic attack
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Cardiac disorders
Palpitations
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Ear and labyrinth disorders
Ear pain
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/100 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
2.0%
1/50 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Vascular disorders
Raynaud's phenomenon
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Vascular disorders
Vein disorder
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Investigations
Intraocular pressure test
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
|
Renal and urinary disorders
Lupus nephritis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
0.00%
0/50 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place