Trial Outcomes & Findings for A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye. (NCT NCT00784719)
NCT ID: NCT00784719
Last Updated: 2013-04-09
Results Overview
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
327 participants
Primary outcome timeframe
Baseline up to Week 8
Results posted on
2013-04-09
Participant Flow
Participant milestones
| Measure |
Placebo Twice Daily
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
47
|
48
|
48
|
44
|
47
|
|
Overall Study
COMPLETED
|
44
|
43
|
46
|
48
|
42
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
0
|
6
|
3
|
5
|
Reasons for withdrawal
| Measure |
Placebo Twice Daily
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Other
|
2
|
1
|
1
|
0
|
2
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
2
|
0
|
1
|
Baseline Characteristics
A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.
Baseline characteristics by cohort
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
62.3 years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 11.57 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 11.73 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 14.57 • n=4 Participants
|
59.9 years
STANDARD_DEVIATION 11.69 • n=21 Participants
|
59.8 years
STANDARD_DEVIATION 14.83 • n=10 Participants
|
58.9 years
STANDARD_DEVIATION 14.25 • n=115 Participants
|
60.0 years
STANDARD_DEVIATION 13.02 • n=24 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
38 Participants
n=115 Participants
|
255 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
72 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 8Population: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Systemic Adverse Events (AEs)
|
27.7 percentage of participants
|
8.7 percentage of participants
|
29.8 percentage of participants
|
27.1 percentage of participants
|
18.8 percentage of participants
|
18.2 percentage of participants
|
23.4 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Ocular Adverse Events (AEs)
|
25.5 percentage of participants
|
21.7 percentage of participants
|
31.9 percentage of participants
|
22.9 percentage of participants
|
22.9 percentage of participants
|
22.7 percentage of participants
|
36.2 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 8Population: ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes \[\<5 min\] after application) or persistent (if continued beyond 5 minutes \[\>=5 min\] after application).
Outcome measures
| Measure |
Placebo Twice Daily
n=45 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=43 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=44 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Ocular Tolerability Assessment
Blurred vision:severe
|
2.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
6.3 percentage of participants
|
4.3 percentage of participants
|
2.3 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Pain:severe
|
0.0 percentage of participants
|
2.2 percentage of participants
|
4.3 percentage of participants
|
2.1 percentage of participants
|
0.0 percentage of participants
|
2.3 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Pain:moderate/severe, duration >=5 min
|
2.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Tearing:none
|
55.6 percentage of participants
|
63.0 percentage of participants
|
68.1 percentage of participants
|
72.9 percentage of participants
|
66.0 percentage of participants
|
69.8 percentage of participants
|
47.7 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Tearing:mild
|
40.0 percentage of participants
|
26.1 percentage of participants
|
21.3 percentage of participants
|
16.7 percentage of participants
|
29.8 percentage of participants
|
11.6 percentage of participants
|
29.5 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Tearing:moderate
|
4.4 percentage of participants
|
10.9 percentage of participants
|
10.6 percentage of participants
|
10.4 percentage of participants
|
4.3 percentage of participants
|
18.6 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Tearing:severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Tearing:moderate/severe, duration >= 5 min
|
0.0 percentage of participants
|
2.2 percentage of participants
|
6.4 percentage of participants
|
2.1 percentage of participants
|
0.0 percentage of participants
|
4.7 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Blurred vision:none
|
51.1 percentage of participants
|
54.3 percentage of participants
|
53.2 percentage of participants
|
58.3 percentage of participants
|
51.1 percentage of participants
|
44.2 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Blurred vision:mild
|
40.0 percentage of participants
|
30.4 percentage of participants
|
34.0 percentage of participants
|
27.1 percentage of participants
|
36.2 percentage of participants
|
34.9 percentage of participants
|
40.9 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Blurred vision:moderate
|
6.7 percentage of participants
|
15.2 percentage of participants
|
12.8 percentage of participants
|
8.3 percentage of participants
|
8.5 percentage of participants
|
18.6 percentage of participants
|
20.5 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Ocular discomfort:none
|
55.6 percentage of participants
|
50.0 percentage of participants
|
53.2 percentage of participants
|
52.1 percentage of participants
|
46.8 percentage of participants
|
69.8 percentage of participants
|
34.1 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Ocular discomfort:mild
|
33.3 percentage of participants
|
28.3 percentage of participants
|
25.5 percentage of participants
|
29.2 percentage of participants
|
44.7 percentage of participants
|
18.6 percentage of participants
|
34.1 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Ocular discomfort:moderate
|
11.1 percentage of participants
|
19.6 percentage of participants
|
19.1 percentage of participants
|
14.6 percentage of participants
|
8.5 percentage of participants
|
9.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Ocular discomfort:severe
|
0.0 percentage of participants
|
2.2 percentage of participants
|
2.1 percentage of participants
|
4.2 percentage of participants
|
0.0 percentage of participants
|
2.3 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Ocular discomfort:moderate/severe, duration>=5 min
|
4.4 percentage of participants
|
10.9 percentage of participants
|
8.5 percentage of participants
|
10.4 percentage of participants
|
4.3 percentage of participants
|
7.0 percentage of participants
|
22.7 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Burning sensation:none
|
26.7 percentage of participants
|
43.5 percentage of participants
|
23.4 percentage of participants
|
33.3 percentage of participants
|
29.8 percentage of participants
|
32.6 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Burning sensation:mild
|
55.6 percentage of participants
|
39.1 percentage of participants
|
59.6 percentage of participants
|
39.6 percentage of participants
|
53.2 percentage of participants
|
48.8 percentage of participants
|
40.9 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Burning sensation:moderate
|
17.8 percentage of participants
|
15.2 percentage of participants
|
14.9 percentage of participants
|
22.9 percentage of participants
|
14.9 percentage of participants
|
16.3 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Burning sensation:severe
|
0.0 percentage of participants
|
2.2 percentage of participants
|
2.1 percentage of participants
|
4.2 percentage of participants
|
2.1 percentage of participants
|
2.3 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Burning sensation:moderate/severe,duration>=5 min
|
0.0 percentage of participants
|
2.2 percentage of participants
|
2.1 percentage of participants
|
0.0 percentage of participants
|
4.3 percentage of participants
|
4.7 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Pain:none
|
82.2 percentage of participants
|
80.4 percentage of participants
|
80.9 percentage of participants
|
85.4 percentage of participants
|
85.1 percentage of participants
|
88.4 percentage of participants
|
61.4 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Pain:mild
|
13.3 percentage of participants
|
10.9 percentage of participants
|
8.5 percentage of participants
|
6.3 percentage of participants
|
12.8 percentage of participants
|
7.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Pain:moderate
|
4.4 percentage of participants
|
6.5 percentage of participants
|
6.4 percentage of participants
|
6.3 percentage of participants
|
2.1 percentage of participants
|
2.3 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Ocular Tolerability Assessment
Blurred vision:moderate/severe, duration >=5 min
|
0.0 percentage of participants
|
2.2 percentage of participants
|
4.3 percentage of participants
|
4.2 percentage of participants
|
6.4 percentage of participants
|
7.0 percentage of participants
|
2.3 percentage of participants
|
PRIMARY outcome
Timeframe: Week 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=45 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=45 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=45 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
|
20.0 percentage of participants
|
17.8 percentage of participants
|
25.5 percentage of participants
|
18.8 percentage of participants
|
26.1 percentage of participants
|
27.3 percentage of participants
|
35.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication.
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
|
NA days
Median and corresponding upper limit of 80% confidence interval (CI) were not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.
|
NA days
Median and corresponding upper limit of 80% CI were not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.
|
59.00 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
58.00 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
NA days
Median and corresponding upper limit of 80% CI were not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.
|
57.00 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
NA days
Median and corresponding upper limit of 80% CI were not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.
|
SECONDARY outcome
Timeframe: Baseline through Week 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication.
Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Time to Achieve 100 Percent (%) Clearance of Corneal Staining
|
NA days
Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
|
NA days
Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
|
NA days
Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
|
NA days
Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
|
NA days
Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
|
NA days
Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
|
NA days
Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
|
SECONDARY outcome
Timeframe: Baseline through Week 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication.
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
|
15.00 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
8.50 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
15.00 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
9.50 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
9.00 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
15.00 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
16.00 days
Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Baseline (n=47,46,47,48,48,44,47)
|
4.15 mm
Standard Deviation 2.07
|
4.40 mm
Standard Deviation 2.20
|
4.02 mm
Standard Deviation 2.12
|
3.77 mm
Standard Deviation 1.87
|
4.43 mm
Standard Deviation 2.29
|
4.40 mm
Standard Deviation 2.24
|
4.74 mm
Standard Deviation 2.03
|
|
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Change at Week 1 (n=45,45,47,47,44,42,43)
|
2.06 mm
Standard Deviation 4.54
|
1.68 mm
Standard Deviation 4.69
|
0.80 mm
Standard Deviation 3.03
|
2.07 mm
Standard Deviation 3.87
|
1.80 mm
Standard Deviation 4.64
|
2.68 mm
Standard Deviation 6.11
|
3.60 mm
Standard Deviation 5.44
|
|
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Change at Week 2 (n=44,46,46,48,45,44,44)
|
2.43 mm
Standard Deviation 4.98
|
1.63 mm
Standard Deviation 4.04
|
2.67 mm
Standard Deviation 4.44
|
3.13 mm
Standard Deviation 4.61
|
2.74 mm
Standard Deviation 4.60
|
3.43 mm
Standard Deviation 6.62
|
3.84 mm
Standard Deviation 5.66
|
|
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Change at Week 4 (n=44,43,45,48,44,39,43)
|
2.42 mm
Standard Deviation 6.64
|
2.69 mm
Standard Deviation 4.56
|
2.56 mm
Standard Deviation 4.76
|
1.72 mm
Standard Deviation 3.60
|
1.66 mm
Standard Deviation 5.03
|
4.21 mm
Standard Deviation 7.03
|
4.06 mm
Standard Deviation 6.65
|
|
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Change at Week 6 (n=43,44,43,47,42,41,43)
|
1.86 mm
Standard Deviation 3.82
|
1.41 mm
Standard Deviation 3.27
|
1.59 mm
Standard Deviation 3.55
|
1.76 mm
Standard Deviation 4.11
|
3.64 mm
Standard Deviation 6.57
|
4.65 mm
Standard Deviation 6.30
|
3.87 mm
Standard Deviation 5.75
|
|
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Change at Week 8 (n=45,46,47,48,47,44,45)
|
1.89 mm
Standard Deviation 5.22
|
2.30 mm
Standard Deviation 4.73
|
2.19 mm
Standard Deviation 4.22
|
3.59 mm
Standard Deviation 6.22
|
2.60 mm
Standard Deviation 4.80
|
3.76 mm
Standard Deviation 6.28
|
4.48 mm
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=43 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Baseline (n=47,46,47,48,48,43,47)
|
6.56 mm
Standard Deviation 4.69
|
7.58 mm
Standard Deviation 4.44
|
6.63 mm
Standard Deviation 5.05
|
6.67 mm
Standard Deviation 4.01
|
7.85 mm
Standard Deviation 5.35
|
7.92 mm
Standard Deviation 5.13
|
8.14 mm
Standard Deviation 5.75
|
|
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Change at Week 8 (n=43,43,45,48,41,39,42)
|
2.24 mm
Standard Deviation 5.07
|
0.13 mm
Standard Deviation 5.47
|
2.56 mm
Standard Deviation 6.11
|
1.48 mm
Standard Deviation 5.48
|
-0.44 mm
Standard Deviation 5.13
|
0.83 mm
Standard Deviation 6.04
|
1.74 mm
Standard Deviation 5.74
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=45 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=45 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=44 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Week 1
|
20.0 percentage of participants
|
9.1 percentage of participants
|
6.4 percentage of participants
|
14.9 percentage of participants
|
11.6 percentage of participants
|
16.7 percentage of participants
|
30.2 percentage of participants
|
|
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Week 2
|
18.2 percentage of participants
|
20.0 percentage of participants
|
23.9 percentage of participants
|
16.7 percentage of participants
|
25.0 percentage of participants
|
22.7 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Week 4
|
18.2 percentage of participants
|
20.9 percentage of participants
|
17.8 percentage of participants
|
10.4 percentage of participants
|
16.3 percentage of participants
|
28.2 percentage of participants
|
30.2 percentage of participants
|
|
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Week 6
|
20.9 percentage of participants
|
9.1 percentage of participants
|
16.3 percentage of participants
|
12.8 percentage of participants
|
34.1 percentage of participants
|
39.0 percentage of participants
|
34.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=43 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=43 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=45 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=41 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=39 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=42 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
|
32.6 percentage of participants
|
27.9 percentage of participants
|
48.9 percentage of participants
|
31.3 percentage of participants
|
24.4 percentage of participants
|
25.6 percentage of participants
|
38.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Change at Week 8 (n=45,46,47,48,47,44,45)
|
-2.67 units on a scale
Standard Deviation 3.44
|
-1.39 units on a scale
Standard Deviation 2.92
|
-1.28 units on a scale
Standard Deviation 2.65
|
-1.58 units on a scale
Standard Deviation 3.04
|
-1.47 units on a scale
Standard Deviation 2.73
|
-2.64 units on a scale
Standard Deviation 2.94
|
-1.18 units on a scale
Standard Deviation 3.50
|
|
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Baseline (n=47,46,47,48,48,44,47)
|
6.64 units on a scale
Standard Deviation 3.45
|
5.63 units on a scale
Standard Deviation 1.95
|
5.83 units on a scale
Standard Deviation 2.10
|
6.73 units on a scale
Standard Deviation 2.94
|
6.21 units on a scale
Standard Deviation 2.54
|
6.36 units on a scale
Standard Deviation 2.71
|
6.85 units on a scale
Standard Deviation 3.50
|
|
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Change at Week 1 (n=45,45,47,47,44,42,44)
|
-1.16 units on a scale
Standard Deviation 2.39
|
-0.89 units on a scale
Standard Deviation 2.05
|
-0.87 units on a scale
Standard Deviation 2.25
|
-1.32 units on a scale
Standard Deviation 2.58
|
-0.20 units on a scale
Standard Deviation 1.95
|
-1.17 units on a scale
Standard Deviation 2.51
|
0.02 units on a scale
Standard Deviation 3.27
|
|
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Change at Week 2 (n=44,46,46,48,45,44,44)
|
-1.02 units on a scale
Standard Deviation 3.16
|
-1.15 units on a scale
Standard Deviation 2.33
|
-1.00 units on a scale
Standard Deviation 2.19
|
-1.98 units on a scale
Standard Deviation 2.50
|
-0.91 units on a scale
Standard Deviation 2.26
|
-1.52 units on a scale
Standard Deviation 2.73
|
-0.61 units on a scale
Standard Deviation 2.94
|
|
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Change at Week 4 (n=44,43,45,48,44,39,43)
|
-2.48 units on a scale
Standard Deviation 2.53
|
-1.02 units on a scale
Standard Deviation 2.58
|
-1.33 units on a scale
Standard Deviation 2.69
|
-1.40 units on a scale
Standard Deviation 2.54
|
-0.82 units on a scale
Standard Deviation 2.45
|
-2.10 units on a scale
Standard Deviation 2.31
|
-1.00 units on a scale
Standard Deviation 2.86
|
|
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Change at Week 6 (n=43,44,43,48,42,41,43)
|
-2.21 units on a scale
Standard Deviation 3.49
|
-1.39 units on a scale
Standard Deviation 2.50
|
-1.21 units on a scale
Standard Deviation 2.42
|
-1.75 units on a scale
Standard Deviation 3.06
|
-1.31 units on a scale
Standard Deviation 3.00
|
-2.27 units on a scale
Standard Deviation 2.69
|
-1.49 units on a scale
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=45 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=44 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Week 1
|
2.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Week 2
|
2.3 percentage of participants
|
4.3 percentage of participants
|
0.0 percentage of participants
|
4.2 percentage of participants
|
0.0 percentage of participants
|
4.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Week 6
|
4.7 percentage of participants
|
6.8 percentage of participants
|
7.0 percentage of participants
|
4.2 percentage of participants
|
7.1 percentage of participants
|
7.3 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Week 8
|
6.7 percentage of participants
|
6.5 percentage of participants
|
4.3 percentage of participants
|
10.4 percentage of participants
|
6.4 percentage of participants
|
15.9 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Week 4
|
4.5 percentage of participants
|
2.3 percentage of participants
|
4.4 percentage of participants
|
6.3 percentage of participants
|
2.3 percentage of participants
|
2.6 percentage of participants
|
4.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8Population: ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=43 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Baseline (n=47,46,47,48,48,43,47)
|
2.77 units on a scale
Standard Deviation 2.36
|
2.17 units on a scale
Standard Deviation 1.43
|
2.21 units on a scale
Standard Deviation 1.81
|
2.38 units on a scale
Standard Deviation 2.08
|
2.17 units on a scale
Standard Deviation 1.99
|
1.91 units on a scale
Standard Deviation 1.66
|
2.43 units on a scale
Standard Deviation 2.03
|
|
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Change at Week 1 (n=45,45,47,47,44,42,43)
|
-0.44 units on a scale
Standard Deviation 1.52
|
-0.38 units on a scale
Standard Deviation 1.76
|
-0.34 units on a scale
Standard Deviation 1.75
|
-0.13 units on a scale
Standard Deviation 2.06
|
-0.45 units on a scale
Standard Deviation 1.42
|
0.17 units on a scale
Standard Deviation 1.50
|
-0.09 units on a scale
Standard Deviation 1.92
|
|
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Change at Week 2 (n=44,46,46,48,45,43,44)
|
-0.89 units on a scale
Standard Deviation 1.53
|
-0.26 units on a scale
Standard Deviation 1.41
|
-0.37 units on a scale
Standard Deviation 1.44
|
-0.29 units on a scale
Standard Deviation 1.57
|
-0.44 units on a scale
Standard Deviation 1.62
|
-0.19 units on a scale
Standard Deviation 1.38
|
0.05 units on a scale
Standard Deviation 2.47
|
|
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Change at Week 4 (n=44,43,45,48,44,39,43)
|
-1.11 units on a scale
Standard Deviation 1.86
|
-0.53 units on a scale
Standard Deviation 1.65
|
-0.60 units on a scale
Standard Deviation 1.56
|
-0.27 units on a scale
Standard Deviation 1.87
|
-0.11 units on a scale
Standard Deviation 1.37
|
0.18 units on a scale
Standard Deviation 1.35
|
-0.07 units on a scale
Standard Deviation 1.64
|
|
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Change at Week 6 (n=43,44,43,48,42,41,43)
|
-0.84 units on a scale
Standard Deviation 1.38
|
-0.73 units on a scale
Standard Deviation 1.63
|
-0.44 units on a scale
Standard Deviation 1.74
|
-0.46 units on a scale
Standard Deviation 1.68
|
-0.12 units on a scale
Standard Deviation 1.71
|
0.02 units on a scale
Standard Deviation 1.98
|
-0.14 units on a scale
Standard Deviation 1.90
|
|
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Change at Week 8 (n=45,46,47,48,47,43,45)
|
-0.82 units on a scale
Standard Deviation 2.01
|
-0.57 units on a scale
Standard Deviation 1.78
|
-0.62 units on a scale
Standard Deviation 1.81
|
-0.63 units on a scale
Standard Deviation 1.71
|
-0.13 units on a scale
Standard Deviation 1.78
|
-0.14 units on a scale
Standard Deviation 1.82
|
-0.18 units on a scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
Change at Week 4 (n=44,43,45,48,44,39,43)
|
0.48 seconds
Standard Deviation 2.14
|
0.61 seconds
Standard Deviation 2.95
|
-0.11 seconds
Standard Deviation 2.31
|
-0.30 seconds
Standard Deviation 4.21
|
0.10 seconds
Standard Deviation 1.50
|
-0.08 seconds
Standard Deviation 2.37
|
0.52 seconds
Standard Deviation 2.43
|
|
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
Baseline (n=47,46,47,48,48,43,47)
|
3.50 seconds
Standard Deviation 1.32
|
3.96 seconds
Standard Deviation 3.30
|
4.32 seconds
Standard Deviation 2.74
|
4.65 seconds
Standard Deviation 6.50
|
4.12 seconds
Standard Deviation 2.44
|
3.90 seconds
Standard Deviation 2.47
|
3.95 seconds
Standard Deviation 2.30
|
|
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
Change at Week 1 (n=45,45,47,47,44,42,44)
|
0.17 seconds
Standard Deviation 1.63
|
0.60 seconds
Standard Deviation 2.11
|
0.21 seconds
Standard Deviation 2.50
|
-0.27 seconds
Standard Deviation 1.55
|
-0.07 seconds
Standard Deviation 1.26
|
-0.51 seconds
Standard Deviation 2.24
|
-0.14 seconds
Standard Deviation 2.00
|
|
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
Change at Week 2 (n=44,46,46,48,45,43,44)
|
0.03 seconds
Standard Deviation 1.40
|
1.04 seconds
Standard Deviation 4.49
|
0.24 seconds
Standard Deviation 3.08
|
-0.44 seconds
Standard Deviation 3.80
|
-0.18 seconds
Standard Deviation 1.01
|
0.04 seconds
Standard Deviation 2.59
|
0.36 seconds
Standard Deviation 2.96
|
|
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
Change at Week 6 (n=43,44,43,48,42,41,43)
|
1.03 seconds
Standard Deviation 4.65
|
0.36 seconds
Standard Deviation 2.77
|
-0.01 seconds
Standard Deviation 2.46
|
-0.71 seconds
Standard Deviation 4.85
|
0.13 seconds
Standard Deviation 1.45
|
-0.21 seconds
Standard Deviation 2.51
|
0.59 seconds
Standard Deviation 3.32
|
|
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
Change at Week 8 (n=45,46,47,48,47,43,45)
|
0.55 seconds
Standard Deviation 2.19
|
0.51 seconds
Standard Deviation 2.93
|
-0.18 seconds
Standard Deviation 2.30
|
-0.04 seconds
Standard Deviation 5.01
|
0.08 seconds
Standard Deviation 1.50
|
0.31 seconds
Standard Deviation 3.54
|
0.52 seconds
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
Change at Week 1 (n=45,45,47,47,44,41,43)
|
-3.7 units on a scale
Standard Deviation 7.28
|
-5.9 units on a scale
Standard Deviation 6.44
|
-4.2 units on a scale
Standard Deviation 6.49
|
-3.9 units on a scale
Standard Deviation 7.68
|
-7.7 units on a scale
Standard Deviation 9.99
|
-4.3 units on a scale
Standard Deviation 7.70
|
-3.8 units on a scale
Standard Deviation 7.79
|
|
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
Change at Week 6 (n=43,44,43,48,42,41,43)
|
-10.1 units on a scale
Standard Deviation 9.75
|
-9.1 units on a scale
Standard Deviation 9.35
|
-8.8 units on a scale
Standard Deviation 7.46
|
-7.5 units on a scale
Standard Deviation 10.31
|
-8.0 units on a scale
Standard Deviation 9.72
|
-7.3 units on a scale
Standard Deviation 10.88
|
-7.2 units on a scale
Standard Deviation 9.36
|
|
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
Change at Week 8 (n=45,46,47,48,47,44,44)
|
-9.6 units on a scale
Standard Deviation 8.98
|
-9.9 units on a scale
Standard Deviation 9.47
|
-8.0 units on a scale
Standard Deviation 8.81
|
-7.4 units on a scale
Standard Deviation 11.34
|
-8.4 units on a scale
Standard Deviation 9.42
|
-8.8 units on a scale
Standard Deviation 9.51
|
-7.1 units on a scale
Standard Deviation 10.16
|
|
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
Baseline (n=47,46,47,48,48,44,47)
|
45.0 units on a scale
Standard Deviation 7.66
|
43.9 units on a scale
Standard Deviation 8.09
|
44.8 units on a scale
Standard Deviation 7.69
|
46.0 units on a scale
Standard Deviation 11.22
|
45.4 units on a scale
Standard Deviation 8.41
|
42.3 units on a scale
Standard Deviation 7.01
|
47.4 units on a scale
Standard Deviation 12.51
|
|
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
Change at Week 2 (n=44,46,46,48,45,43,44)
|
-6.3 units on a scale
Standard Deviation 7.89
|
-6.0 units on a scale
Standard Deviation 5.92
|
-6.2 units on a scale
Standard Deviation 9.00
|
-5.9 units on a scale
Standard Deviation 7.30
|
-7.6 units on a scale
Standard Deviation 9.89
|
-4.4 units on a scale
Standard Deviation 9.13
|
-6.8 units on a scale
Standard Deviation 10.59
|
|
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
Change at Week 4 (n=44,43,45,48,44,41,43)
|
-8.9 units on a scale
Standard Deviation 8.44
|
-7.6 units on a scale
Standard Deviation 9.73
|
-6.8 units on a scale
Standard Deviation 8.58
|
-5.7 units on a scale
Standard Deviation 11.33
|
-8.5 units on a scale
Standard Deviation 10.88
|
-6.1 units on a scale
Standard Deviation 8.33
|
-5.2 units on a scale
Standard Deviation 8.23
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.
Outcome measures
| Measure |
Placebo Twice Daily
n=45 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=44 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
Week 1
|
44.4 percentage of participants
|
53.3 percentage of participants
|
38.3 percentage of participants
|
53.2 percentage of participants
|
56.8 percentage of participants
|
43.9 percentage of participants
|
39.5 percentage of participants
|
|
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
Week 4
|
68.2 percentage of participants
|
60.5 percentage of participants
|
55.6 percentage of participants
|
58.3 percentage of participants
|
65.9 percentage of participants
|
51.2 percentage of participants
|
46.5 percentage of participants
|
|
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
Week 6
|
72.1 percentage of participants
|
68.2 percentage of participants
|
72.1 percentage of participants
|
62.5 percentage of participants
|
61.9 percentage of participants
|
51.2 percentage of participants
|
51.2 percentage of participants
|
|
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
Week 2
|
56.8 percentage of participants
|
52.2 percentage of participants
|
45.7 percentage of participants
|
62.5 percentage of participants
|
57.8 percentage of participants
|
48.8 percentage of participants
|
52.3 percentage of participants
|
|
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
Week 8
|
64.4 percentage of participants
|
71.7 percentage of participants
|
59.6 percentage of participants
|
60.4 percentage of participants
|
57.4 percentage of participants
|
59.1 percentage of participants
|
52.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8Population: ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=43 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Baseline (n=47,46,47,48,48,43,47)
|
3.4 drops/day
Standard Deviation 1.58
|
3.0 drops/day
Standard Deviation 1.63
|
3.0 drops/day
Standard Deviation 1.16
|
2.5 drops/day
Standard Deviation 1.65
|
3.0 drops/day
Standard Deviation 1.65
|
2.8 drops/day
Standard Deviation 1.20
|
2.9 drops/day
Standard Deviation 1.60
|
|
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Change at Week 8 (n=46,46,47,48,47,43,46)
|
-1.2 drops/day
Standard Deviation 1.36
|
-1.6 drops/day
Standard Deviation 1.20
|
-1.0 drops/day
Standard Deviation 1.19
|
-1.2 drops/day
Standard Deviation 1.04
|
-1.1 drops/day
Standard Deviation 1.52
|
-1.5 drops/day
Standard Deviation 1.27
|
-0.9 drops/day
Standard Deviation 1.34
|
|
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Change at Week 1 (n=45,46,47,48,47,43,45)
|
-0.7 drops/day
Standard Deviation 1.27
|
-1.1 drops/day
Standard Deviation 0.99
|
-0.8 drops/day
Standard Deviation 1.01
|
-0.8 drops/day
Standard Deviation 1.01
|
-0.9 drops/day
Standard Deviation 1.33
|
-1.1 drops/day
Standard Deviation 1.01
|
-0.6 drops/day
Standard Deviation 1.17
|
|
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Change at Week 2 (n=44,46,45,48,47,42,44)
|
-0.9 drops/day
Standard Deviation 1.31
|
-1.2 drops/day
Standard Deviation 1.09
|
-0.8 drops/day
Standard Deviation 1.20
|
-0.9 drops/day
Standard Deviation 0.99
|
-0.9 drops/day
Standard Deviation 1.28
|
-1.0 drops/day
Standard Deviation 1.03
|
-0.6 drops/day
Standard Deviation 1.21
|
|
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Change at Week 4 (n=44,44,45,48,45,41,44)
|
-1.1 drops/day
Standard Deviation 1.60
|
-1.5 drops/day
Standard Deviation 1.22
|
-0.9 drops/day
Standard Deviation 1.08
|
-1.0 drops/day
Standard Deviation 0.95
|
-0.9 drops/day
Standard Deviation 1.29
|
-1.2 drops/day
Standard Deviation 1.27
|
-0.8 drops/day
Standard Deviation 1.42
|
|
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Change at Week 6 (n=44,44,46,48,43,40,43)
|
-1.5 drops/day
Standard Deviation 1.51
|
-1.5 drops/day
Standard Deviation 1.08
|
-0.9 drops/day
Standard Deviation 1.15
|
-1.1 drops/day
Standard Deviation 1.07
|
-1.0 drops/day
Standard Deviation 1.60
|
-1.3 drops/day
Standard Deviation 1.10
|
-0.7 drops/day
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8Population: ITT population. LOCF method was used for imputing missing data at Week 8. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 \[Q1\]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=43 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Baseline:total (n=47,46,46,48,48,43,47)
|
37.6 units on a scale
Standard Deviation 21.46
|
35.6 units on a scale
Standard Deviation 19.71
|
31.5 units on a scale
Standard Deviation 17.95
|
41.8 units on a scale
Standard Deviation 22.04
|
37.8 units on a scale
Standard Deviation 18.76
|
35.6 units on a scale
Standard Deviation 22.45
|
41.8 units on a scale
Standard Deviation 22.93
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Baseline:symptoms (n=47,46,46,48,48,43,47)
|
39.7 units on a scale
Standard Deviation 22.87
|
38.8 units on a scale
Standard Deviation 21.60
|
38.6 units on a scale
Standard Deviation 20.66
|
45.7 units on a scale
Standard Deviation 24.37
|
41.7 units on a scale
Standard Deviation 22.87
|
35.9 units on a scale
Standard Deviation 20.86
|
47.3 units on a scale
Standard Deviation 24.64
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Baseline:function (n=46,46,45,48,47,43,44)
|
31.8 units on a scale
Standard Deviation 21.05
|
28.8 units on a scale
Standard Deviation 20.30
|
23.5 units on a scale
Standard Deviation 19.55
|
38.3 units on a scale
Standard Deviation 26.66
|
31.8 units on a scale
Standard Deviation 20.74
|
31.3 units on a scale
Standard Deviation 27.07
|
36.1 units on a scale
Standard Deviation 26.02
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 1:total (n=45,45,46,47,44,40,43)
|
-6.8 units on a scale
Standard Deviation 14.39
|
-5.1 units on a scale
Standard Deviation 13.61
|
-6.3 units on a scale
Standard Deviation 13.79
|
-8.9 units on a scale
Standard Deviation 11.43
|
-6.5 units on a scale
Standard Deviation 17.18
|
-9.2 units on a scale
Standard Deviation 17.13
|
-4.7 units on a scale
Standard Deviation 12.46
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 1:function (n=43,45,44,47,43,39,39)
|
-6.1 units on a scale
Standard Deviation 15.49
|
-3.7 units on a scale
Standard Deviation 16.32
|
-4.4 units on a scale
Standard Deviation 13.48
|
-9.1 units on a scale
Standard Deviation 14.77
|
-4.4 units on a scale
Standard Deviation 19.94
|
-9.1 units on a scale
Standard Deviation 17.81
|
-7.3 units on a scale
Standard Deviation 16.84
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 1:triggers (n=43,39,39,43,38,35,39)
|
-7.9 units on a scale
Standard Deviation 23.64
|
-12.0 units on a scale
Standard Deviation 24.05
|
-6.6 units on a scale
Standard Deviation 24.74
|
-10.2 units on a scale
Standard Deviation 18.88
|
-14.7 units on a scale
Standard Deviation 23.12
|
-15.0 units on a scale
Standard Deviation 28.19
|
-2.4 units on a scale
Standard Deviation 18.97
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 2:total (n=44,46,45,48,45,43,44)
|
-8.7 units on a scale
Standard Deviation 12.60
|
-6.2 units on a scale
Standard Deviation 12.09
|
-8.6 units on a scale
Standard Deviation 13.66
|
-8.9 units on a scale
Standard Deviation 13.08
|
-4.7 units on a scale
Standard Deviation 19.01
|
-10.3 units on a scale
Standard Deviation 20.16
|
-7.3 units on a scale
Standard Deviation 16.51
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 2:symptoms (n=44,46,45,48,45,43,44)
|
-9.1 units on a scale
Standard Deviation 18.49
|
-6.2 units on a scale
Standard Deviation 13.99
|
-11.5 units on a scale
Standard Deviation 17.79
|
-11.5 units on a scale
Standard Deviation 18.12
|
-6.9 units on a scale
Standard Deviation 19.41
|
-9.7 units on a scale
Standard Deviation 21.74
|
-7.6 units on a scale
Standard Deviation 17.77
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 2:function (n=42,46,42,48,43,43,41)
|
-8.6 units on a scale
Standard Deviation 14.26
|
-5.8 units on a scale
Standard Deviation 13.67
|
-5.5 units on a scale
Standard Deviation 12.92
|
-7.6 units on a scale
Standard Deviation 16.52
|
-3.5 units on a scale
Standard Deviation 23.92
|
-7.0 units on a scale
Standard Deviation 19.10
|
-8.6 units on a scale
Standard Deviation 19.44
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 4:total (n=44,43,44,48,44,41,43)
|
-11.5 units on a scale
Standard Deviation 15.88
|
-7.2 units on a scale
Standard Deviation 12.98
|
-8.1 units on a scale
Standard Deviation 15.53
|
-9.7 units on a scale
Standard Deviation 14.12
|
-10.0 units on a scale
Standard Deviation 20.92
|
-11.3 units on a scale
Standard Deviation 17.12
|
-7.0 units on a scale
Standard Deviation 13.95
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Baseline:triggers (n=46,41,42,45,42,41,43)
|
46.7 units on a scale
Standard Deviation 30.81
|
49.8 units on a scale
Standard Deviation 29.64
|
42.0 units on a scale
Standard Deviation 31.63
|
46.1 units on a scale
Standard Deviation 29.64
|
45.6 units on a scale
Standard Deviation 29.52
|
44.8 units on a scale
Standard Deviation 26.92
|
50.3 units on a scale
Standard Deviation 30.12
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 1:symptoms (n=45,45,46,47,44,40,43)
|
-5.9 units on a scale
Standard Deviation 16.73
|
-4.1 units on a scale
Standard Deviation 15.85
|
-8.5 units on a scale
Standard Deviation 17.52
|
-8.2 units on a scale
Standard Deviation 17.59
|
-6.3 units on a scale
Standard Deviation 20.26
|
-6.9 units on a scale
Standard Deviation 17.99
|
-4.5 units on a scale
Standard Deviation 13.03
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 2:triggers (n=42,40,40,38,35,39,40)
|
-9.9 units on a scale
Standard Deviation 18.38
|
-7.9 units on a scale
Standard Deviation 24.98
|
-8.8 units on a scale
Standard Deviation 24.76
|
-9.4 units on a scale
Standard Deviation 16.60
|
-10.1 units on a scale
Standard Deviation 29.00
|
-19.2 units on a scale
Standard Deviation 29.05
|
-5.5 units on a scale
Standard Deviation 21.42
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 4:symptoms (n=44,43,44,48,44,41,43)
|
-12.1 units on a scale
Standard Deviation 18.19
|
-8.5 units on a scale
Standard Deviation 12.79
|
-13.4 units on a scale
Standard Deviation 20.27
|
-10.9 units on a scale
Standard Deviation 18.37
|
-10.8 units on a scale
Standard Deviation 23.47
|
-10.4 units on a scale
Standard Deviation 18.61
|
-6.6 units on a scale
Standard Deviation 15.06
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 4:function (n=43,42,42,47,41,41,40)
|
-10.2 units on a scale
Standard Deviation 16.42
|
-4.7 units on a scale
Standard Deviation 15.98
|
-6.3 units on a scale
Standard Deviation 16.97
|
-8.5 units on a scale
Standard Deviation 16.77
|
-5.1 units on a scale
Standard Deviation 20.37
|
-7.3 units on a scale
Standard Deviation 18.75
|
-8.7 units on a scale
Standard Deviation 17.83
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 4:triggers (n=43,36,39,43,36,37,39)
|
-13.5 units on a scale
Standard Deviation 26.02
|
-10.4 units on a scale
Standard Deviation 21.90
|
-5.8 units on a scale
Standard Deviation 30.16
|
-9.8 units on a scale
Standard Deviation 23.23
|
-16.3 units on a scale
Standard Deviation 29.55
|
-21.5 units on a scale
Standard Deviation 25.07
|
-4.7 units on a scale
Standard Deviation 20.90
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 6:function (n=42,44,38,46,40,41,40)
|
-9.1 units on a scale
Standard Deviation 18.88
|
-7.0 units on a scale
Standard Deviation 15.30
|
-5.1 units on a scale
Standard Deviation 14.46
|
-9.6 units on a scale
Standard Deviation 14.74
|
-3.7 units on a scale
Standard Deviation 20.10
|
-9.3 units on a scale
Standard Deviation 19.34
|
-8.3 units on a scale
Standard Deviation 17.09
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 6:triggers (n=40,38,37,41,34,38,39)
|
-13.2 units on a scale
Standard Deviation 21.62
|
-13.0 units on a scale
Standard Deviation 24.80
|
-9.7 units on a scale
Standard Deviation 23.61
|
-9.2 units on a scale
Standard Deviation 24.85
|
-12.4 units on a scale
Standard Deviation 32.88
|
-24.5 units on a scale
Standard Deviation 28.3
|
-5.9 units on a scale
Standard Deviation 22.65
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 6:total (n=43,44,42,48,42,41,43)
|
-10.5 units on a scale
Standard Deviation 14.26
|
-9.1 units on a scale
Standard Deviation 14.19
|
-7.9 units on a scale
Standard Deviation 13.89
|
-10.9 units on a scale
Standard Deviation 14.33
|
-8.1 units on a scale
Standard Deviation 20.48
|
-14.0 units on a scale
Standard Deviation 19.43
|
-7.7 units on a scale
Standard Deviation 14.00
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 6:symptoms (n=43,44,42,48,42,41,43)
|
-11.2 units on a scale
Standard Deviation 18.36
|
-10.0 units on a scale
Standard Deviation 13.76
|
-12.3 units on a scale
Standard Deviation 17.96
|
-11.4 units on a scale
Standard Deviation 19.52
|
-7.1 units on a scale
Standard Deviation 21.03
|
-13.4 units on a scale
Standard Deviation 21.80
|
-9.1 units on a scale
Standard Deviation 15.52
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 8:total (n=45,46,46,48,32,35,39)
|
-11.0 units on a scale
Standard Deviation 18.55
|
-8.5 units on a scale
Standard Deviation 15.34
|
-7.6 units on a scale
Standard Deviation 15.22
|
-8.8 units on a scale
Standard Deviation 16.56
|
-9.5 units on a scale
Standard Deviation 20.92
|
-12.7 units on a scale
Standard Deviation 18.21
|
-6.6 units on a scale
Standard Deviation 16.11
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 8:symptoms (n=45,46,46,48,47,43,44)
|
-13.1 units on a scale
Standard Deviation 20.37
|
-8.9 units on a scale
Standard Deviation 16.14
|
-11.6 units on a scale
Standard Deviation 20.52
|
-11.6 units on a scale
Standard Deviation 20.68
|
-10.5 units on a scale
Standard Deviation 23.98
|
-14.3 units on a scale
Standard Deviation 21.54
|
-7.4 units on a scale
Standard Deviation 17.72
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 8:function (n=44,46,45,48,46,43,41)
|
-9.1 units on a scale
Standard Deviation 21.31
|
-6.4 units on a scale
Standard Deviation 16.54
|
-4.5 units on a scale
Standard Deviation 14.82
|
-9.2 units on a scale
Standard Deviation 18.33
|
-6.2 units on a scale
Standard Deviation 23.86
|
-9.2 units on a scale
Standard Deviation 18.31
|
-6.8 units on a scale
Standard Deviation 19.72
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Change at Week 8:triggers(n=44,41,42,45,,41,41,41)
|
-12.2 units on a scale
Standard Deviation 24.86
|
-14.2 units on a scale
Standard Deviation 24.46
|
-8.4 units on a scale
Standard Deviation 23.62
|
-6.4 units on a scale
Standard Deviation 29.08
|
-13.5 units on a scale
Standard Deviation 29.07
|
-19.6 units on a scale
Standard Deviation 26.06
|
-4.8 units on a scale
Standard Deviation 23.62
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.
Outcome measures
| Measure |
Placebo Twice Daily
n=45 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=43 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=44 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
Week 4
|
47.7 percentage of participants
|
44.2 percentage of participants
|
38.6 percentage of participants
|
50.0 percentage of participants
|
45.5 percentage of participants
|
41.5 percentage of participants
|
44.2 percentage of participants
|
|
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
Week 8
|
40.0 percentage of participants
|
50.0 percentage of participants
|
41.3 percentage of participants
|
47.9 percentage of participants
|
44.7 percentage of participants
|
46.5 percentage of participants
|
38.6 percentage of participants
|
|
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
Week 1
|
37.8 percentage of participants
|
37.8 percentage of participants
|
34.8 percentage of participants
|
46.8 percentage of participants
|
45.5 percentage of participants
|
40.0 percentage of participants
|
37.2 percentage of participants
|
|
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
Week 2
|
50.0 percentage of participants
|
45.7 percentage of participants
|
40.0 percentage of participants
|
43.8 percentage of participants
|
33.3 percentage of participants
|
39.5 percentage of participants
|
43.2 percentage of participants
|
|
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
Week 6
|
46.5 percentage of participants
|
52.3 percentage of participants
|
35.7 percentage of participants
|
52.1 percentage of participants
|
40.5 percentage of participants
|
51.2 percentage of participants
|
39.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8Population: Data for OSDI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.
OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8Population: Data for mOCI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.
mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 8Population: ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.
Outcome measures
| Measure |
Placebo Twice Daily
n=47 Participants
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 Participants
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 Participants
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=43 Participants
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 Participants
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: GH (n=46,46,47,48,48,43,47)
|
65.22 Units on a scale
Standard Deviation 20.74
|
66.85 Units on a scale
Standard Deviation 21.12
|
62.77 Units on a scale
Standard Deviation 20.10
|
66.15 Units on a scale
Standard Deviation 24.99
|
59.90 Units on a scale
Standard Deviation 23.49
|
66.86 Units on a scale
Standard Deviation 25.43
|
57.98 Units on a scale
Standard Deviation 20.92
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: GV (n=47,46,47,48,48,43,47)
|
72.77 Units on a scale
Standard Deviation 16.38
|
75.65 Units on a scale
Standard Deviation 12.59
|
73.62 Units on a scale
Standard Deviation 14.51
|
72.50 Units on a scale
Standard Deviation 20.05
|
72.08 Units on a scale
Standard Deviation 13.52
|
70.70 Units on a scale
Standard Deviation 17.10
|
73.19 Units on a scale
Standard Deviation 13.37
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: OP (n=47,46,47,48,48,43,47)
|
59.31 Units on a scale
Standard Deviation 18.70
|
59.51 Units on a scale
Standard Deviation 18.85
|
61.17 Units on a scale
Standard Deviation 20.89
|
53.65 Units on a scale
Standard Deviation 23.06
|
55.47 Units on a scale
Standard Deviation 19.28
|
56.40 Units on a scale
Standard Deviation 17.76
|
50.27 Units on a scale
Standard Deviation 24.76
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: NAct (n=47,46,47,48,48,43,47)
|
68.62 Units on a scale
Standard Deviation 18.49
|
70.92 Units on a scale
Standard Deviation 17.53
|
76.60 Units on a scale
Standard Deviation 18.60
|
64.41 Units on a scale
Standard Deviation 23.36
|
66.06 Units on a scale
Standard Deviation 20.01
|
72.00 Units on a scale
Standard Deviation 21.53
|
64.36 Units on a scale
Standard Deviation 23.36
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: DA (n=47,46,47,48,48,43,47)
|
73.76 Units on a scale
Standard Deviation 17.63
|
77.36 Units on a scale
Standard Deviation 17.71
|
81.38 Units on a scale
Standard Deviation 16.32
|
72.05 Units on a scale
Standard Deviation 25.12
|
73.00 Units on a scale
Standard Deviation 17.13
|
71.90 Units on a scale
Standard Deviation 20.66
|
69.33 Units on a scale
Standard Deviation 21.92
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: SF (n=47,46,47,48,48,43,47)
|
89.10 Units on a scale
Standard Deviation 14.89
|
93.21 Units on a scale
Standard Deviation 10.77
|
93.88 Units on a scale
Standard Deviation 11.62
|
86.46 Units on a scale
Standard Deviation 21.39
|
89.84 Units on a scale
Standard Deviation 14.51
|
87.79 Units on a scale
Standard Deviation 18.99
|
85.64 Units on a scale
Standard Deviation 20.52
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: MH (n=47,46,47,48,48,43,47)
|
72.34 Units on a scale
Standard Deviation 24.55
|
73.23 Units on a scale
Standard Deviation 19.88
|
77.53 Units on a scale
Standard Deviation 19.71
|
64.84 Units on a scale
Standard Deviation 26.13
|
67.97 Units on a scale
Standard Deviation 22.94
|
72.67 Units on a scale
Standard Deviation 22.24
|
70.35 Units on a scale
Standard Deviation 23.73
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: RD (n=47,46,47,48,48,43,47)
|
68.09 Units on a scale
Standard Deviation 23.28
|
72.83 Units on a scale
Standard Deviation 20.12
|
76.33 Units on a scale
Standard Deviation 25.96
|
61.98 Units on a scale
Standard Deviation 29.73
|
67.71 Units on a scale
Standard Deviation 26.02
|
68.02 Units on a scale
Standard Deviation 26.91
|
68.09 Units on a scale
Standard Deviation 27.81
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline:dependency (n=47,45,47,47,48,43,47)
|
88.48 Units on a scale
Standard Deviation 21.46
|
93.89 Units on a scale
Standard Deviation 10.42
|
94.33 Units on a scale
Standard Deviation 11.54
|
81.91 Units on a scale
Standard Deviation 25.79
|
88.02 Units on a scale
Standard Deviation 23.34
|
87.79 Units on a scale
Standard Deviation 22.15
|
89.72 Units on a scale
Standard Deviation 19.90
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline:driving (n=46,44,45,46,41,41,44)
|
73.64 Units on a scale
Standard Deviation 17.15
|
76.89 Units on a scale
Standard Deviation 15.65
|
77.22 Units on a scale
Standard Deviation 19.09
|
78.44 Units on a scale
Standard Deviation 20.38
|
71.54 Units on a scale
Standard Deviation 22.28
|
71.65 Units on a scale
Standard Deviation 21.23
|
71.12 Units on a scale
Standard Deviation 19.80
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: CV (n=46,46,47,48,48,43,47)
|
89.67 Units on a scale
Standard Deviation 21.46
|
96.20 Units on a scale
Standard Deviation 9.08
|
93.62 Units on a scale
Standard Deviation 13.26
|
90.10 Units on a scale
Standard Deviation 18.41
|
93.75 Units on a scale
Standard Deviation 14.12
|
91.28 Units on a scale
Standard Deviation 17.15
|
90.43 Units on a scale
Standard Deviation 17.72
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: PV (n=47,46,46,48,46,43,47)
|
77.13 Units on a scale
Standard Deviation 23.21
|
82.61 Units on a scale
Standard Deviation 20.32
|
85.87 Units on a scale
Standard Deviation 21.51
|
80.21 Units on a scale
Standard Deviation 25.24
|
79.89 Units on a scale
Standard Deviation 21.49
|
79.65 Units on a scale
Standard Deviation 26.31
|
80.32 Units on a scale
Standard Deviation 22.68
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Baseline: Overall (n=47,46,47,48,48,43,47)
|
75.62 Units on a scale
Standard Deviation 14.43
|
79.30 Units on a scale
Standard Deviation 10.95
|
81.08 Units on a scale
Standard Deviation 12.99
|
73.19 Units on a scale
Standard Deviation 19.31
|
75.06 Units on a scale
Standard Deviation 13.96
|
75.40 Units on a scale
Standard Deviation 15.58
|
73.97 Units on a scale
Standard Deviation 16.76
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: GH (n=42,43,44,48,41,40,41)
|
0.00 Units on a scale
Standard Deviation 13.53
|
-2.91 Units on a scale
Standard Deviation 14.65
|
0.00 Units on a scale
Standard Deviation 15.25
|
2.08 Units on a scale
Standard Deviation 19.18
|
1.22 Units on a scale
Standard Deviation 18.50
|
-0.63 Units on a scale
Standard Deviation 14.42
|
1.83 Units on a scale
Standard Deviation 10.29
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: GV (n=43,43,44,48,41,40,41)
|
1.86 Units on a scale
Standard Deviation 16.22
|
1.86 Units on a scale
Standard Deviation 12.20
|
1.36 Units on a scale
Standard Deviation 7.95
|
3.75 Units on a scale
Standard Deviation 12.82
|
1.46 Units on a scale
Standard Deviation 18.11
|
5.00 Units on a scale
Standard Deviation 15.53
|
-0.49 Units on a scale
Standard Deviation 10.48
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: OP (n=43,43,44,48,41,40,41)
|
15.12 Units on a scale
Standard Deviation 19.59
|
11.63 Units on a scale
Standard Deviation 21.89
|
13.35 Units on a scale
Standard Deviation 20.95
|
9.38 Units on a scale
Standard Deviation 15.79
|
11.59 Units on a scale
Standard Deviation 19.24
|
16.56 Units on a scale
Standard Deviation 20.88
|
9.45 Units on a scale
Standard Deviation 19.72
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: NAct (n=43,43,44,48,41,40,41)
|
7.17 Units on a scale
Standard Deviation 17.21
|
8.62 Units on a scale
Standard Deviation 15.33
|
4.17 Units on a scale
Standard Deviation 12.64
|
7.12 Units on a scale
Standard Deviation 16.49
|
10.87 Units on a scale
Standard Deviation 19.07
|
7.40 Units on a scale
Standard Deviation 15.49
|
9.96 Units on a scale
Standard Deviation 19.65
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: DA (n=43,43,44,48,41,40,41)
|
6.78 Units on a scale
Standard Deviation 12.50
|
5.43 Units on a scale
Standard Deviation 13.22
|
3.03 Units on a scale
Standard Deviation 13.46
|
4.43 Units on a scale
Standard Deviation 11.32
|
8.84 Units on a scale
Standard Deviation 17.88
|
8.85 Units on a scale
Standard Deviation 17.66
|
5.89 Units on a scale
Standard Deviation 14.67
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: SF (n=43,43,44,48,41,40,41)
|
3.20 Units on a scale
Standard Deviation 12.82
|
2.62 Units on a scale
Standard Deviation 11.75
|
2.27 Units on a scale
Standard Deviation 10.54
|
3.39 Units on a scale
Standard Deviation 13.58
|
5.79 Units on a scale
Standard Deviation 13.43
|
6.88 Units on a scale
Standard Deviation 18.55
|
8.23 Units on a scale
Standard Deviation 12.06
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: MH (n=43,43,44,48,41,40,41)
|
10.61 Units on a scale
Standard Deviation 19.27
|
9.59 Units on a scale
Standard Deviation 17.27
|
4.55 Units on a scale
Standard Deviation 13.57
|
5.34 Units on a scale
Standard Deviation 15.95
|
11.28 Units on a scale
Standard Deviation 18.92
|
10.63 Units on a scale
Standard Deviation 22.30
|
5.95 Units on a scale
Standard Deviation 16.41
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: RD (n=43,43,44,48,41,40,41)
|
6.98 Units on a scale
Standard Deviation 15.74
|
5.52 Units on a scale
Standard Deviation 27.59
|
4.55 Units on a scale
Standard Deviation 20.37
|
5.47 Units on a scale
Standard Deviation 18.93
|
8.23 Units on a scale
Standard Deviation 24.94
|
12.50 Units on a scale
Standard Deviation 25.94
|
0.00 Units on a scale
Standard Deviation 29.05
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change Week 8:dependency(n=43,42,44,47,41,40,41)
|
7.56 Units on a scale
Standard Deviation 21.32
|
1.19 Units on a scale
Standard Deviation 15.79
|
1.89 Units on a scale
Standard Deviation 8.96
|
4.61 Units on a scale
Standard Deviation 14.83
|
5.39 Units on a scale
Standard Deviation 19.59
|
7.08 Units on a scale
Standard Deviation 17.45
|
2.24 Units on a scale
Standard Deviation 11.94
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8:driving (n=42,41,42,46,33,38,39)
|
6.15 Units on a scale
Standard Deviation 14.47
|
3.46 Units on a scale
Standard Deviation 16.24
|
3.27 Units on a scale
Standard Deviation 13.64
|
0.36 Units on a scale
Standard Deviation 12.29
|
3.91 Units on a scale
Standard Deviation 14.43
|
8.22 Units on a scale
Standard Deviation 13.65
|
3.95 Units on a scale
Standard Deviation 13.07
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: CV (n=42,43,44,48,41,40,41)
|
4.76 Units on a scale
Standard Deviation 13.79
|
2.33 Units on a scale
Standard Deviation 9.15
|
3.98 Units on a scale
Standard Deviation 10.71
|
2.08 Units on a scale
Standard Deviation 16.97
|
2.44 Units on a scale
Standard Deviation 13.47
|
5.63 Units on a scale
Standard Deviation 19.19
|
4.88 Units on a scale
Standard Deviation 16.03
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: PV (n=43,43,44,48,39,40,41)
|
11.05 Units on a scale
Standard Deviation 22.03
|
4.07 Units on a scale
Standard Deviation 15.36
|
1.70 Units on a scale
Standard Deviation 15.62
|
3.65 Units on a scale
Standard Deviation 18.59
|
6.41 Units on a scale
Standard Deviation 21.24
|
6.88 Units on a scale
Standard Deviation 20.40
|
6.71 Units on a scale
Standard Deviation 20.17
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Change at Week 8: Overall (n=43,43,44,48,41,40,41)
|
7.44 Units on a scale
Standard Deviation 9.55
|
5.13 Units on a scale
Standard Deviation 9.20
|
3.98 Units on a scale
Standard Deviation 7.44
|
4.50 Units on a scale
Standard Deviation 8.19
|
7.15 Units on a scale
Standard Deviation 11.60
|
8.67 Units on a scale
Standard Deviation 11.50
|
5.15 Units on a scale
Standard Deviation 10.42
|
Adverse Events
Placebo Twice Daily
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
CP-690,550, 0.0003% Twice Daily
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
CP-690,550, 0.001% Twice Daily
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
CP-690,550, 0.003% Twice Daily
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
CP-690,550, 0.005% Twice Daily
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
CP-690,550, 0.005% Once Daily
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Restasis Twice Daily
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Twice Daily
n=47 participants at risk
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 participants at risk
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 participants at risk
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 participants at risk
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 participants at risk
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 participants at risk
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 participants at risk
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Placebo Twice Daily
n=47 participants at risk
One drop (45 microliter \[mcL\]) of matching placebo solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.0003% Twice Daily
n=46 participants at risk
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.001% Twice Daily
n=47 participants at risk
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.003% Twice Daily
n=48 participants at risk
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Twice Daily
n=48 participants at risk
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
|
CP-690,550, 0.005% Once Daily
n=44 participants at risk
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
|
Restasis Twice Daily
n=47 participants at risk
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Abnormal sensation in eye, BOTH EYES
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Asthenopia, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Blepharitis, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract nuclear, BOTH EYES
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Chalazion, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid disorder, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival cyst, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival hyperaemia, BOTH EYES
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival hyperaemia, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.2%
2/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival hyperaemia, STUDY EYE ONLY
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival oedema, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival oedema, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival oedema, STUDY EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Corneal deposits, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Corneal disorder, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Corneal disorder, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Corneal epithelium defect, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Corneal erosion, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Corneal oedema, STUDY EYE ONLY
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Dry eye, BOTH EYES
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Erythema of eyelid, STUDY EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Excessive eye blinking, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye disorder, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye irritation, BOTH EYES
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.2%
2/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.2%
2/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye irritation, FELLOW EYE ONLY
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain, BOTH EYES
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
2/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pruritus, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
2/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pruritus, FELLOW EYE ONLY
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye swelling, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid irritation, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid irritation, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid margin crusting, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid oedema, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Foreign body sensation in eyes, BOTH EYES
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Iritis, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Lacrimation increased, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Lacrimation increased, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Meibomian gland dysfunction, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
2/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Meibomian gland dysfunction, FELLOW EYE ONLY
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Meibomian gland dysfunction, STUDY EYE ONLY
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Myodesopsia, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Myodesopsia, STUDY EYE ONLY
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Ocular discomfort, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Ocular hyperaemia, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Ocular hyperaemia, STUDY EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Photophobia, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Punctate keratitis, BOTH EYES
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Punctate keratitis, STUDY EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Trichiasis, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred, BOTH EYES
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.2%
2/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.2%
2/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual acuity reduced, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual acuity reduced, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual acuity reduced, STUDY EYE ONLY
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual impairment, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Palatal disorder
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Instillation site pain, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
2/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Instillation site pain, STUDY EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Instillation site pruritus, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Sensation of foreign body, FELLOW EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Temperature intolerance, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Conjunctivitis bacterial, STUDY EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Eyelid infection
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.2%
2/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Perichondritis
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
2/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
2/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contact lens complication, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Corneal abrasion, STUDY EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Foreign body trauma, FELLOW EYE ONLY
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Superficial injury of eye, STUDY EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood cholesterol increased
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose increased
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood triglycerides abnormal
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Burning sensation, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia, STUDY EYE ONLY
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Social circumstances
Impaired work ability, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Injection, BOTH EYES
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hyperaemia
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/44
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER