Trial Outcomes & Findings for Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis (NCT NCT01751126)
NCT ID: NCT01751126
Last Updated: 2022-03-28
Results Overview
Efficacy was assessed every month during the 4-month treatment phase and compared with Baseline using a composite criterion based on: * Keratitis assessed by the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5). On this modified scale, the score 0 corresponded to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represented complete corneal clearing. * Need for rescue medication. * Occurrence of corneal ulceration. An efficacy score was calculated as follows: Patient's score at month X = CFS (Baseline) - CFS (Month X) + penalty (ies) Penalty for rescue medication: -1 (per course, with a maximum of 2 courses between 2 scheduled visits) Penalty for corneal ulceration: -1 (per occurrence). A positive value indicated improvement. The maximum CFS is five and the minimum cannot be set due to the number of rescue medication and ulceration which decreases the penalty adjusted CFS.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
169 participants
Primary outcome timeframe
over the 4 months
Results posted on
2022-03-28
Participant Flow
Participant milestones
| Measure |
High Dose Regimen
1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening).
|
Low Dose Regimen
1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.
|
Placebo
1 drop of placebo 4 times a day as monotherapy.
|
|---|---|---|---|
|
Period I
STARTED
|
57
|
54
|
58
|
|
Period I
COMPLETED
|
51
|
43
|
49
|
|
Period I
NOT COMPLETED
|
6
|
11
|
9
|
|
Period II
STARTED
|
72
|
70
|
0
|
|
Period II
COMPLETED
|
72
|
70
|
0
|
|
Period II
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
Baseline characteristics by cohort
| Measure |
High Dose Regimen
n=56 Participants
1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening).
|
Low Dose Regimen
n=54 Participants
1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.
|
Placebo
n=58 Participants
1 drop of placebo 4 times a day as monotherapy.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Children (4-18 years)
|
9.1 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
8.9 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
9.2 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: over the 4 monthsEfficacy was assessed every month during the 4-month treatment phase and compared with Baseline using a composite criterion based on: * Keratitis assessed by the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5). On this modified scale, the score 0 corresponded to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represented complete corneal clearing. * Need for rescue medication. * Occurrence of corneal ulceration. An efficacy score was calculated as follows: Patient's score at month X = CFS (Baseline) - CFS (Month X) + penalty (ies) Penalty for rescue medication: -1 (per course, with a maximum of 2 courses between 2 scheduled visits) Penalty for corneal ulceration: -1 (per occurrence). A positive value indicated improvement. The maximum CFS is five and the minimum cannot be set due to the number of rescue medication and ulceration which decreases the penalty adjusted CFS.
Outcome measures
| Measure |
High Dose Regimen
n=56 Participants
1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening).
|
Low Dose Regimen
n=54 Participants
1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.
|
Placebo
n=58 Participants
1 drop of placebo 4 times a day as monotherapy.
|
Change From Baseline in LogMAR- High Dose
|
Change From Baseline in LogMAR- Low Dose
|
Change From Baseline in LogMAR- Placebo
|
|---|---|---|---|---|---|---|
|
Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months
|
2.06 Penalties Adjusted CFS Score
Standard Deviation 1.44
|
1.93 Penalties Adjusted CFS Score
Standard Deviation 1.37
|
1.34 Penalties Adjusted CFS Score
Standard Deviation 1.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Month4Population: SS population
Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicates poor vision.
Outcome measures
| Measure |
High Dose Regimen
n=57 Participants
1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening).
|
Low Dose Regimen
n=54 Participants
1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.
|
Placebo
n=58 Participants
1 drop of placebo 4 times a day as monotherapy.
|
Change From Baseline in LogMAR- High Dose
n=57 Participants
|
Change From Baseline in LogMAR- Low Dose
n=54 Participants
|
Change From Baseline in LogMAR- Placebo
n=58 Participants
|
|---|---|---|---|---|---|---|
|
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
Analysis Eye-Month 2
|
0.221 letters
Standard Deviation 0.251
|
0.146 letters
Standard Deviation 0.214
|
0.331 letters
Standard Deviation 0.352
|
-0.071 letters
Standard Deviation 0.191
|
-0.073 letters
Standard Deviation 0.202
|
0.003 letters
Standard Deviation 0.233
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
Analysis Eye-Baseline
|
0.293 letters
Standard Deviation 0.297
|
0.209 letters
Standard Deviation 0.284
|
0.302 letters
Standard Deviation 0.347
|
0 letters
Standard Deviation 0
|
0 letters
Standard Deviation 0
|
0 letters
Standard Deviation 0
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
Analysis Eye-Month 1
|
0.263 letters
Standard Deviation 0.292
|
0.160 letters
Standard Deviation 0.241
|
0.285 letters
Standard Deviation 0.362
|
-0.036 letters
Standard Deviation 0.187
|
-0.058 letters
Standard Deviation 0.199
|
-0.027 letters
Standard Deviation 0.182
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
Analysis Eye-Month 3
|
0.172 letters
Standard Deviation 0.235
|
0.110 letters
Standard Deviation 0.204
|
0.273 letters
Standard Deviation 0.318
|
-0.110 letters
Standard Deviation 0.173
|
-0.089 letters
Standard Deviation 0.233
|
-0.066 letters
Standard Deviation 0.229
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
Analysis Eye-Month 4
|
0.149 letters
Standard Deviation 0.244
|
0.097 letters
Standard Deviation 0.203
|
0.237 letters
Standard Deviation 0.308
|
-0.127 letters
Standard Deviation 0.165
|
-0.110 letters
Standard Deviation 0.233
|
-0.109 letters
Standard Deviation 0.211
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
Analysis Eye-Month 4/ Early Termination
|
0.158 letters
Standard Deviation 0.249
|
0.114 letters
Standard Deviation 0.212
|
0.217 letters
Standard Deviation 0.295
|
-0.135 letters
Standard Deviation 0.220
|
-0.091 letters
Standard Deviation 0.257
|
-0.097 letters
Standard Deviation 0.210
|
SECONDARY outcome
Timeframe: Up to Month12Population: SS population
Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicate poor vision.
Outcome measures
| Measure |
High Dose Regimen
n=50 Participants
1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening).
|
Low Dose Regimen
n=22 Participants
1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.
|
Placebo
n=72 Participants
1 drop of placebo 4 times a day as monotherapy.
|
Change From Baseline in LogMAR- High Dose
n=50 Participants
|
Change From Baseline in LogMAR- Low Dose
n=22 Participants
|
Change From Baseline in LogMAR- Placebo
n=72 Participants
|
|---|---|---|---|---|---|---|
|
Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
Analysis Eye-Baseline (Month 4)
|
0.152 letters
Standard Deviation 0.246
|
0.250 letters
Standard Deviation 0.317
|
0.181 letters
Standard Deviation 0.270
|
0 letters
Standard Deviation 0
|
0 letters
Standard Deviation 0
|
0 letters
Standard Deviation 0
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
Analysis Eye-Month 6
|
0.128 letters
Standard Deviation 0.230
|
0.258 letters
Standard Deviation 0.359
|
0.168 letters
Standard Deviation 0.280
|
-0.024 letters
Standard Deviation 0.114
|
-0.017 letters
Standard Deviation 0.143
|
-0.022 letters
Standard Deviation 0.122
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
Analysis Eye-Month 8
|
0.141 letters
Standard Deviation 0.228
|
0.222 letters
Standard Deviation 0.324
|
0.165 letters
Standard Deviation 0.261
|
-0.015 letters
Standard Deviation 0.136
|
-0.029 letters
Standard Deviation 0.155
|
-0.019 letters
Standard Deviation 0.141
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
Analysis Eye-Month 10
|
0.141 letters
Standard Deviation 0.222
|
0.207 letters
Standard Deviation 0.325
|
0.160 letters
Standard Deviation 0.257
|
-0.014 letters
Standard Deviation 0.149
|
-0.044 letters
Standard Deviation 0.128
|
-0.023 letters
Standard Deviation 0.143
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
Analysis Eye-Month 12
|
0.134 letters
Standard Deviation 0.214
|
0.220 letters
Standard Deviation 0.363
|
0.160 letters
Standard Deviation 0.268
|
-0.020 letters
Standard Deviation 0.152
|
-0.030 letters
Standard Deviation 0.172
|
-0.023 letters
Standard Deviation 0.157
|
|
Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
Analysis Eye-Month 12/ Early Termination
|
0.136 letters
Standard Deviation 0.212
|
0.220 letters
Standard Deviation 0.363
|
0.161 letters
Standard Deviation 0.266
|
-0.016 letters
Standard Deviation 0.154
|
-0.030 letters
Standard Deviation 0.172
|
-0.020 letters
Standard Deviation 0.158
|
SECONDARY outcome
Timeframe: Up to Month4Population: Participants reduced due to missing data
Use of rescue medication: the total number of topical corticosteroid courses was assessed at each visit during the 4-month efficacy evaluation treatment period.
Outcome measures
| Measure |
High Dose Regimen
n=56 Participants
1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening).
|
Low Dose Regimen
n=54 Participants
1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.
|
Placebo
n=58 Participants
1 drop of placebo 4 times a day as monotherapy.
|
Change From Baseline in LogMAR- High Dose
|
Change From Baseline in LogMAR- Low Dose
|
Change From Baseline in LogMAR- Placebo
|
|---|---|---|---|---|---|---|
|
Number of Courses of Rescue Medication in Period I
Month1, zero course
|
51 Participants
|
41 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month 1, one course
|
3 Participants
|
7 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month1, two courses
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month2, zero course
|
45 Participants
|
43 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month 2, one course
|
6 Participants
|
2 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month 2, two courses
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month3, zero course
|
43 Participants
|
42 Participants
|
34 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month3, one course
|
7 Participants
|
2 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month 3, two courses
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month4, zero course
|
42 Participants
|
41 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month4, one course
|
6 Participants
|
2 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month 4, two courses
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month 4/Early Termination, zero course
|
46 Participants
|
46 Participants
|
43 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month 4/Early Termination, one course
|
7 Participants
|
5 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Courses of Rescue Medication in Period I
Month 4/Early Termination, two courses
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
Adverse Events
.1% QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Vehicle QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Total High Dose
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
.1% BID + Vehicle BID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Vehicle QID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Total Low Dose
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
.1% QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)
n=50 participants at risk
Participants in this group received High dose in Period I (4 months) and continuing in High dose in the follow up period (8 months).
|
Vehicle QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)
n=22 participants at risk
Participants in this group received Placebo in Period I (4 months) and continuing in High dose in the follow up period (8 months).
|
Total High Dose
n=72 participants at risk
Total of participants that received High dose from the overall study period (0-12 months).
|
.1% BID + Vehicle BID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)
n=44 participants at risk
Participants in this group received Low dose in Period I (4 months) and continuing in Low dose in the follow up period (8 months).
|
Vehicle QID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)
n=26 participants at risk
Participants in this group received Placebo in Period I (4 months) and continuing in Low dose in the follow up period (8 months).
|
Total Low Dose
n=70 participants at risk
Total of participants that received High dose from the overall study period (0-12 months).
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Ulcerative keratitis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Congenital, familial and genetic disorders
Phimosis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
Other adverse events
| Measure |
.1% QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)
n=50 participants at risk
Participants in this group received High dose in Period I (4 months) and continuing in High dose in the follow up period (8 months).
|
Vehicle QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)
n=22 participants at risk
Participants in this group received Placebo in Period I (4 months) and continuing in High dose in the follow up period (8 months).
|
Total High Dose
n=72 participants at risk
Total of participants that received High dose from the overall study period (0-12 months).
|
.1% BID + Vehicle BID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)
n=44 participants at risk
Participants in this group received Low dose in Period I (4 months) and continuing in Low dose in the follow up period (8 months).
|
Vehicle QID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)
n=26 participants at risk
Participants in this group received Placebo in Period I (4 months) and continuing in Low dose in the follow up period (8 months).
|
Total Low Dose
n=70 participants at risk
Total of participants that received High dose from the overall study period (0-12 months).
|
|---|---|---|---|---|---|---|
|
Eye disorders
Ocular hyperaemia
|
4.0%
2/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
9.1%
2/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
5.6%
4/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
13.6%
3/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.2%
3/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Corneal leukoma
|
4.0%
2/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.8%
2/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Ulcerative keratitis
|
4.0%
2/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.8%
2/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Eye irritation
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.9%
2/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Foreign body sensation in eyes
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
9.1%
2/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.8%
2/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Abnormal sensation in eye
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Blepharitis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Conjunctival irritation
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Corneal deposits
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Corneal neovascularisation
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Diplopia
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Erythema of eyelid
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Eye pain
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Eyelid erosion
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Eyelid ptosis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Lacrimation increased
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Meibomianitis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
3/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.2%
3/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
11.4%
5/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
8.6%
6/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Influenza
|
8.0%
4/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
5.6%
4/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Eye disorders
Pharyngitis
|
4.0%
2/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.8%
2/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
7.7%
2/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.9%
2/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Tonsillitis
|
4.0%
2/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.8%
2/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
2/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.9%
2/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Laryngitis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Rhinitis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
2/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.8%
2/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Conjunctivitis viral
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Folliculitis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Tooth abscess
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Varicella
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Infections and infestations
Viral infection
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
General disorders
Instillation site pain
|
12.0%
6/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
18.2%
4/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
13.9%
10/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
11.4%
5/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
7.1%
5/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
General disorders
Instillation site pruritus
|
4.0%
2/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
13.6%
3/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
6.9%
5/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
9.1%
4/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
5.7%
4/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
General disorders
Instillation site erythema
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
9.1%
2/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.2%
3/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
2/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.9%
2/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
General disorders
Pyrexia
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
2/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.3%
3/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
General disorders
Application site discharge
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
General disorders
Application site erosion
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
General disorders
Application site swelling
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
General disorders
Instillation site foreign body sensation
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
General disorders
Instillation site lacrimation
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
3/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
5.6%
4/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.9%
2/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.9%
2/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic respiratory disease
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.9%
2/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Skin and subcutaneous tissue disorders
Papule
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Gastrointestinal disorders
Oral pain
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Nervous system disorders
Headache
|
8.0%
4/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
6.9%
5/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Investigations
Intraocular pressure decreased
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Investigations
Protein total increased
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
3.8%
1/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
4.5%
1/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
2.3%
1/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
|
Surgical and medical procedures
Removal of internal fixation
|
2.0%
1/50 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/22 • From the time the informed consent form was signed until the last study visit at Month 12.
|
1.4%
1/72 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/44 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/26 • From the time the informed consent form was signed until the last study visit at Month 12.
|
0.00%
0/70 • From the time the informed consent form was signed until the last study visit at Month 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place