Trial Outcomes & Findings for Non-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom (NCT NCT01012245)
NCT ID: NCT01012245
Last Updated: 2021-02-25
Results Overview
Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).
Recruitment status
COMPLETED
Target enrollment
28812 participants
Primary outcome timeframe
Baseline, 1 year, 2 years, and 3 years
Results posted on
2021-02-25
Participant Flow
Open-label, prospective, multi-center, non-interventional cohort study (NIS) at 385 centers (office-based ophthalmologists); number of subjects per center was not limited.
Subjects were assigned to a therapeutic strategy within current practice and not according to a protocol.
Participant milestones
| Measure |
Subjects With Glaucoma and Ocular Hypertension
All subjects group: documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups: Xalatan®: subjects with Xalatan® (latanoprost) monotherapy at baseline visit; Betablockers: subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit; Xalacom®: subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit; other medications: subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|
|
Overall Study
STARTED
|
28812
|
|
Overall Study
COMPLETED
|
26385
|
|
Overall Study
NOT COMPLETED
|
2427
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom
Baseline characteristics by cohort
| Measure |
Xalatan®
n=13486 Participants
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
n=1884 Participants
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit
|
Xalacom®
n=746 Participants
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medication
n=12696 Participants
Subjects with other or no hypotensive therapy at baseline visit
|
Total
n=28812 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Glaucoma diagnosis at baseline
Pigment dispersion glaucoma OD
|
135 participants
n=5 Participants
|
13 participants
n=7 Participants
|
8 participants
n=5 Participants
|
155 participants
n=4 Participants
|
311 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Pigment dispersion glaucoma OS
|
137 participants
n=5 Participants
|
13 participants
n=7 Participants
|
9 participants
n=5 Participants
|
150 participants
n=4 Participants
|
309 participants
n=21 Participants
|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
65.9 years
STANDARD_DEVIATION 13.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7636 Participants
n=5 Participants
|
1101 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
7493 Participants
n=4 Participants
|
16613 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5850 Participants
n=5 Participants
|
783 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
5203 Participants
n=4 Participants
|
12199 Participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Concomitant ocular disease (right eye [OD])
|
13137 participants
n=5 Participants
|
1846 participants
n=7 Participants
|
731 participants
n=5 Participants
|
12328 participants
n=4 Participants
|
28042 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Concomitant ocular disease (left eye [OS])
|
13179 participants
n=5 Participants
|
1847 participants
n=7 Participants
|
732 participants
n=5 Participants
|
12350 participants
n=4 Participants
|
28108 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
No concomitant diseases OD
|
6737 participants
n=5 Participants
|
1060 participants
n=7 Participants
|
315 participants
n=5 Participants
|
4742 participants
n=4 Participants
|
12854 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
No concomitant diseases OS
|
6730 participants
n=5 Participants
|
1067 participants
n=7 Participants
|
308 participants
n=5 Participants
|
4757 participants
n=4 Participants
|
12862 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
At least 1 concomitant disease OD
|
5426 participants
n=5 Participants
|
786 participants
n=7 Participants
|
416 participants
n=5 Participants
|
6488 participants
n=4 Participants
|
13116 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
At least 1 concomitant disease OS
|
5460 participants
n=5 Participants
|
780 participants
n=7 Participants
|
424 participants
n=5 Participants
|
6492 participants
n=4 Participants
|
13156 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Status post cataract surgery OD
|
309 participants
n=5 Participants
|
39 participants
n=7 Participants
|
21 participants
n=5 Participants
|
731 participants
n=4 Participants
|
1100 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Status post cataract surgery OS
|
338 participants
n=5 Participants
|
40 participants
n=7 Participants
|
19 participants
n=5 Participants
|
752 participants
n=4 Participants
|
1149 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Status post glaucoma surgery OD
|
1276 participants
n=5 Participants
|
189 participants
n=7 Participants
|
109 participants
n=5 Participants
|
1799 participants
n=4 Participants
|
3373 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Status post glaucoma surgery OS
|
1292 participants
n=5 Participants
|
184 participants
n=7 Participants
|
107 participants
n=5 Participants
|
1729 participants
n=4 Participants
|
3312 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Status post laser surgery for glaucoma OD
|
656 participants
n=5 Participants
|
56 participants
n=7 Participants
|
54 participants
n=5 Participants
|
1070 participants
n=4 Participants
|
1836 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Status post laser surgery for glaucoma OS
|
637 participants
n=5 Participants
|
56 participants
n=7 Participants
|
64 participants
n=5 Participants
|
1061 participants
n=4 Participants
|
1818 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Cataract OD
|
2297 participants
n=5 Participants
|
370 participants
n=7 Participants
|
209 participants
n=5 Participants
|
2542 participants
n=4 Participants
|
5418 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Cataract OS
|
2302 participants
n=5 Participants
|
370 participants
n=7 Participants
|
220 participants
n=5 Participants
|
2587 participants
n=4 Participants
|
5479 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Other disease OD
|
2249 participants
n=5 Participants
|
280 participants
n=7 Participants
|
147 participants
n=5 Participants
|
2639 participants
n=4 Participants
|
5315 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Other disease OS
|
2269 participants
n=5 Participants
|
285 participants
n=7 Participants
|
143 participants
n=5 Participants
|
2633 participants
n=4 Participants
|
5330 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Missing values OD
|
974 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1098 participants
n=4 Participants
|
2072 participants
n=21 Participants
|
|
Concomitant ocular diseases at baseline
Missing values OS
|
989 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1101 participants
n=4 Participants
|
2090 participants
n=21 Participants
|
|
Concomitant systemic diseases at baseline
No concomitant diseases
|
6895 participants
n=5 Participants
|
1045 participants
n=7 Participants
|
396 participants
n=5 Participants
|
5734 participants
n=4 Participants
|
14070 participants
n=21 Participants
|
|
Concomitant systemic diseases at baseline
At least 1 concomitant disease
|
5638 participants
n=5 Participants
|
839 participants
n=7 Participants
|
350 participants
n=5 Participants
|
5854 participants
n=4 Participants
|
12681 participants
n=21 Participants
|
|
Concomitant systemic diseases at baseline
Diabetes mellitus
|
1644 participants
n=5 Participants
|
247 participants
n=7 Participants
|
107 participants
n=5 Participants
|
1743 participants
n=4 Participants
|
3741 participants
n=21 Participants
|
|
Concomitant systemic diseases at baseline
Asthma
|
532 participants
n=5 Participants
|
43 participants
n=7 Participants
|
4 participants
n=5 Participants
|
484 participants
n=4 Participants
|
1063 participants
n=21 Participants
|
|
Concomitant systemic diseases at baseline
Cardiac insufficiency
|
891 participants
n=5 Participants
|
136 participants
n=7 Participants
|
48 participants
n=5 Participants
|
1118 participants
n=4 Participants
|
2193 participants
n=21 Participants
|
|
Concomitant systemic diseases at baseline
Hypotension
|
347 participants
n=5 Participants
|
75 participants
n=7 Participants
|
24 participants
n=5 Participants
|
288 participants
n=4 Participants
|
734 participants
n=21 Participants
|
|
Concomitant systemic diseases at baseline
Hypertension
|
2257 participants
n=5 Participants
|
453 participants
n=7 Participants
|
192 participants
n=5 Participants
|
2288 participants
n=4 Participants
|
5190 participants
n=21 Participants
|
|
Concomitant systemic diseases at baseline
Other disease
|
1696 participants
n=5 Participants
|
200 participants
n=7 Participants
|
75 participants
n=5 Participants
|
1902 participants
n=4 Participants
|
3873 participants
n=21 Participants
|
|
Concomitant systemic diseases at baseline
Missing values
|
953 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1108 participants
n=4 Participants
|
2061 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Glaucoma chronicum simplex OD
|
9863 participants
n=5 Participants
|
1595 participants
n=7 Participants
|
560 participants
n=5 Participants
|
9266 participants
n=4 Participants
|
21284 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Glaucoma chronicum simplex OS
|
9874 participants
n=5 Participants
|
1590 participants
n=7 Participants
|
562 participants
n=5 Participants
|
9269 participants
n=4 Participants
|
21295 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Normal tension glaucoma OD
|
818 participants
n=5 Participants
|
51 participants
n=7 Participants
|
55 participants
n=5 Participants
|
486 participants
n=4 Participants
|
1410 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Normal tension glaucoma OS
|
834 participants
n=5 Participants
|
53 participants
n=7 Participants
|
53 participants
n=5 Participants
|
507 participants
n=4 Participants
|
1447 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Chronic narrow-angle glaucoma OD
|
496 participants
n=5 Participants
|
43 participants
n=7 Participants
|
22 participants
n=5 Participants
|
804 participants
n=4 Participants
|
1365 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Chronic narrow-angle glaucoma OS
|
503 participants
n=5 Participants
|
43 participants
n=7 Participants
|
22 participants
n=5 Participants
|
804 participants
n=4 Participants
|
1372 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Congenital glaucoma OD
|
26 participants
n=5 Participants
|
7 participants
n=7 Participants
|
0 participants
n=5 Participants
|
58 participants
n=4 Participants
|
91 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Congenital glaucoma OS
|
24 participants
n=5 Participants
|
8 participants
n=7 Participants
|
1 participants
n=5 Participants
|
55 participants
n=4 Participants
|
88 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Exfoliation glaucoma OD
|
339 participants
n=5 Participants
|
41 participants
n=7 Participants
|
15 participants
n=5 Participants
|
381 participants
n=4 Participants
|
776 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Exfoliation glaucoma OS
|
335 participants
n=5 Participants
|
36 participants
n=7 Participants
|
16 participants
n=5 Participants
|
390 participants
n=4 Participants
|
777 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Neovascular glaucoma OD
|
27 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
93 participants
n=4 Participants
|
128 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Neovascular glaucoma OS
|
30 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
73 participants
n=4 Participants
|
114 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Other secondary glaucoma OD
|
152 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
242 participants
n=4 Participants
|
426 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Other secondary glaucoma OS
|
158 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
262 participants
n=4 Participants
|
446 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Acute angle closure OD
|
11 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Acute angle closure OS
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
9 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Ocular hypertension OD
|
987 participants
n=5 Participants
|
60 participants
n=7 Participants
|
45 participants
n=5 Participants
|
467 participants
n=4 Participants
|
1559 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Ocular hypertension OS
|
987 participants
n=5 Participants
|
63 participants
n=7 Participants
|
46 participants
n=5 Participants
|
468 participants
n=4 Participants
|
1564 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Other glaucoma OD
|
283 participants
n=5 Participants
|
16 participants
n=7 Participants
|
3 participants
n=5 Participants
|
365 participants
n=4 Participants
|
667 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Other glaucoma OS
|
287 participants
n=5 Participants
|
21 participants
n=7 Participants
|
2 participants
n=5 Participants
|
363 participants
n=4 Participants
|
673 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
No glaucoma OD
|
262 participants
n=5 Participants
|
38 participants
n=7 Participants
|
14 participants
n=5 Participants
|
267 participants
n=4 Participants
|
581 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
No glaucoma OS
|
230 participants
n=5 Participants
|
37 participants
n=7 Participants
|
13 participants
n=5 Participants
|
259 participants
n=4 Participants
|
539 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Missing values OD
|
87 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
101 participants
n=4 Participants
|
189 participants
n=21 Participants
|
|
Glaucoma diagnosis at baseline
Missing values OS
|
77 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
87 participants
n=4 Participants
|
165 participants
n=21 Participants
|
|
Duration of glaucoma disease at baseline
|
5.1 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
6.0 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
6.6 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
6.6 years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
5.9 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 year, 2 years, and 3 yearsPopulation: All subjects group and each treatment group population. N=number of participants with IOP data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.
Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).
Outcome measures
| Measure |
All Subjects
n=20073 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
n=8735 Participants
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
n=1508 Participants
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
n=494 Participants
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
n=9336 Participants
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP)
1 year (n=10886,4134, 357, 209, 3029)
|
-1.5 mm Hg
Standard Deviation 4.4
|
-0.7 mm Hg
Standard Deviation 3.5
|
-1.0 mm Hg
Standard Deviation 3.4
|
-0.2 mm Hg
Standard Deviation 3.5
|
-1.1 mm Hg
Standard Deviation 4.6
|
|
Change From Baseline in Intraocular Pressure (IOP)
2 years (n=7558, 2631, 175, 80, 1834)
|
-1.6 mm Hg
Standard Deviation 4.5
|
-0.7 mm Hg
Standard Deviation 3.6
|
-0.8 mm Hg
Standard Deviation 3.2
|
-0.5 mm Hg
Standard Deviation 3.1
|
-1.4 mm Hg
Standard Deviation 4.6
|
|
Change From Baseline in Intraocular Pressure (IOP)
3 years (n=5023, 1753, 64, 40, 1115)
|
-1.6 mm Hg
Standard Deviation 4.5
|
-0.7 mm Hg
Standard Deviation 3.7
|
-1.2 mm Hg
Standard Deviation 3.1
|
-0.3 mm Hg
Standard Deviation 3.2
|
-1.4 mm Hg
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Baseline, 1 year, 2 years, and 3 yearsPopulation: All subjects group and all treatment groups populations
Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.
Outcome measures
| Measure |
All Subjects
n=28812 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
n=13486 Participants
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
n=1884 Participants
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
n=746 Participants
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
n=12696 Participants
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Aulhorn Stage (Visual Field Defects)
Baseline: No scotoma
|
7753 participants
|
4074 participants
|
493 participants
|
200 participants
|
2986 participants
|
|
Aulhorn Stage (Visual Field Defects)
Baseline: Stage I
|
3759 participants
|
1915 participants
|
254 participants
|
68 participants
|
1522 participants
|
|
Aulhorn Stage (Visual Field Defects)
Baseline: Stage II
|
1904 participants
|
826 participants
|
119 participants
|
47 participants
|
912 participants
|
|
Aulhorn Stage (Visual Field Defects)
Baseline: Stage III
|
1313 participants
|
467 participants
|
51 participants
|
57 participants
|
738 participants
|
|
Aulhorn Stage (Visual Field Defects)
Baseline: Stage IV
|
949 participants
|
268 participants
|
29 participants
|
17 participants
|
635 participants
|
|
Aulhorn Stage (Visual Field Defects)
Baseline: Stage V
|
646 participants
|
210 participants
|
13 participants
|
8 participants
|
415 participants
|
|
Aulhorn Stage (Visual Field Defects)
Baseline: missing values
|
12488 participants
|
5726 participants
|
925 participants
|
349 participants
|
5488 participants
|
|
Aulhorn Stage (Visual Field Defects)
1 year: No scotoma
|
4493 participants
|
2068 participants
|
157 participants
|
94 participants
|
903 participants
|
|
Aulhorn Stage (Visual Field Defects)
1 year: Stage I
|
1763 participants
|
840 participants
|
24 participants
|
23 participants
|
423 participants
|
|
Aulhorn Stage (Visual Field Defects)
1 year: Stage II
|
868 participants
|
326 participants
|
9 participants
|
18 participants
|
279 participants
|
|
Aulhorn Stage (Visual Field Defects)
1 year: Stage III
|
576 participants
|
180 participants
|
3 participants
|
12 participants
|
259 participants
|
|
Aulhorn Stage (Visual Field Defects)
1 year: Stage IV
|
372 participants
|
83 participants
|
1 participants
|
9 participants
|
204 participants
|
|
Aulhorn Stage (Visual Field Defects)
1 year: Stage V
|
212 participants
|
57 participants
|
1 participants
|
3 participants
|
112 participants
|
|
Aulhorn Stage (Visual Field Defects)
1 year: missing values
|
8820 participants
|
3438 participants
|
171 participants
|
168 participants
|
2342 participants
|
|
Aulhorn Stage (Visual Field Defects)
2 years: No scotoma
|
3374 participants
|
1491 participants
|
121 participants
|
43 participants
|
572 participants
|
|
Aulhorn Stage (Visual Field Defects)
2 years: Stage I
|
1339 participants
|
583 participants
|
13 participants
|
8 participants
|
287 participants
|
|
Aulhorn Stage (Visual Field Defects)
2 years: Stage II
|
603 participants
|
193 participants
|
3 participants
|
7 participants
|
190 participants
|
|
Aulhorn Stage (Visual Field Defects)
2 years: Stage III
|
396 participants
|
120 participants
|
0 participants
|
4 participants
|
162 participants
|
|
Aulhorn Stage (Visual Field Defects)
2 years: Stage IV
|
241 participants
|
53 participants
|
1 participants
|
0 participants
|
124 participants
|
|
Aulhorn Stage (Visual Field Defects)
2 years: Stage V
|
141 participants
|
34 participants
|
2 participants
|
1 participants
|
61 participants
|
|
Aulhorn Stage (Visual Field Defects)
2 years: missing values
|
6107 participants
|
2181 participants
|
40 participants
|
76 participants
|
1471 participants
|
|
Aulhorn Stage (Visual Field Defects)
3 years: No scotoma
|
2323 participants
|
1017 participants
|
16 participants
|
21 participants
|
347 participants
|
|
Aulhorn Stage (Visual Field Defects)
3 years: Stage I
|
933 participants
|
416 participants
|
10 participants
|
5 participants
|
185 participants
|
|
Aulhorn Stage (Visual Field Defects)
3 years: Stage II
|
420 participants
|
132 participants
|
7 participants
|
2 participants
|
120 participants
|
|
Aulhorn Stage (Visual Field Defects)
3 years: Stage III
|
288 participants
|
82 participants
|
3 participants
|
1 participants
|
119 participants
|
|
Aulhorn Stage (Visual Field Defects)
3 years: Stage IV
|
173 participants
|
38 participants
|
2 participants
|
2 participants
|
89 participants
|
|
Aulhorn Stage (Visual Field Defects)
3 years: Stage V
|
80 participants
|
17 participants
|
0 participants
|
0 participants
|
35 participants
|
|
Aulhorn Stage (Visual Field Defects)
3 years: missing values
|
4283 participants
|
1515 participants
|
26 participants
|
32 participants
|
924 participants
|
PRIMARY outcome
Timeframe: Baseline, 1 year, 2 years, and 3 yearsPopulation: All subjects group and all treatment groups populations. N=number of participants with optic disc excavation data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.
Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Outcome measures
| Measure |
All Subjects
n=20375 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
n=9521 Participants
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
n=1276 Participants
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
n=497 Participants
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
n=9081 Participants
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
1 year (n=11190, 4638, 72, 236, 2714)
|
0.00 ratio
Standard Deviation 0.07
|
0.00 ratio
Standard Deviation 0.07
|
0.02 ratio
Standard Deviation 0.08
|
0.01 ratio
Standard Deviation 0.07
|
0.00 ratio
Standard Deviation 0.08
|
|
Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
2 years (n=8088, 3128, 26, 93, 1756)
|
0.01 ratio
Standard Deviation 0.08
|
0.01 ratio
Standard Deviation 0.08
|
0.00 ratio
Standard Deviation 0.09
|
0.02 ratio
Standard Deviation 0.07
|
0.01 ratio
Standard Deviation 0.08
|
|
Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
3 years (n=5784, 2173, 16, 34, 1170)
|
0.01 ratio
Standard Deviation 0.09
|
0.01 ratio
Standard Deviation 0.08
|
0.03 ratio
Standard Deviation 0.09
|
0.02 ratio
Standard Deviation 0.11
|
0.01 ratio
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: Baseline, 1 year, 2 years, and 3 yearsPopulation: All subjects group and all treatment groups populations. N=number of subjects with optic disc excavation data at baseline; (n)=number of subjects with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.
Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Outcome measures
| Measure |
All Subjects
n=19316 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
n=9203 Participants
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
n=1226 Participants
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
n=469 Participants
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
n=8418 Participants
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
3 years (n=5500, 2089, 16, 33, 1067)
|
0.01 ratio
Standard Deviation 0.09
|
0.01 ratio
Standard Deviation 0.07
|
0.01 ratio
Standard Deviation 0.08
|
0.02 ratio
Standard Deviation 0.11
|
0.01 ratio
Standard Deviation 0.10
|
|
Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
2 years (n=7727, 3003, 26, 88, 1630)
|
0.00 ratio
Standard Deviation 0.08
|
0.00 ratio
Standard Deviation 0.07
|
0.00 ratio
Standard Deviation 0.10
|
0.01 ratio
Standard Deviation 0.06
|
0.01 ratio
Standard Deviation 0.09
|
|
Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
1 year (n=10602, 4496, 71, 227, 2442)
|
0.00 ratio
Standard Deviation 0.07
|
0.00 ratio
Standard Deviation 0.06
|
0.02 ratio
Standard Deviation 0.08
|
0.01 ratio
Standard Deviation 0.07
|
0.00 ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Baseline, 1 year, 2 years, and 3 yearsPopulation: Xalatan® treatment group only (subjects with Xalatan® monotherapy at baseline visit).
Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective).
Outcome measures
| Measure |
All Subjects
n=13486 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Investigator Assessment of Xalatan® Efficacy
Baseline: Excellent
|
555 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
Baseline: Very good
|
978 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
Baseline: Good
|
538 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
Baseline: Moderate
|
92 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
Baseline: Sufficient
|
15 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
Baseline: Insufficient
|
23 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
Baseline: missing values
|
11285 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
1 year: Excellent
|
910 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
1 year: Very good
|
3216 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
1 year: Good
|
2489 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
1 year: Moderate
|
310 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
1 year: Sufficient
|
30 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
1 year: Insufficient
|
34 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
1 year: missing values
|
3 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
2 years: Excellent
|
475 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
2 years: Very good
|
2153 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
2 years: Good
|
1828 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
2 years: Moderate
|
164 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
2 years: Sufficient
|
23 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
2 years: Insufficient
|
10 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
2 years: missing values
|
2 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
3 years: Excellent
|
256 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
3 years: Very good
|
1548 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
3 years: Good
|
1307 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
3 years: Moderate
|
74 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
3 years: Sufficient
|
19 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
3 years: Insufficient
|
11 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Xalatan® Efficacy
3 years: missing values
|
2 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 year, 2 years, and 3 yearsPopulation: Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).
Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction).
Outcome measures
| Measure |
All Subjects
n=13486 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
Baseline: Excellent
|
901 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
Baseline: Very good
|
737 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
Baseline: Good
|
404 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
Baseline: Moderate
|
35 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
Baseline: Sufficient
|
110 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
Baseline: Insufficient
|
7 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
Baseline: missing values
|
11292 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
1 year: Excellent
|
1078 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
1 year: Very good
|
3200 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
1 year: Good
|
2510 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
1 year: Moderate
|
169 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
1 year: Sufficient
|
16 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
1 year: Insufficient
|
16 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
1 year: missing values
|
3 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
2 years: Excellent
|
621 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
2 years: Very good
|
2082 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
2 years: Good
|
1832 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
2 years: Moderate
|
106 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
2 years: Sufficient
|
8 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
2 years: Insufficient
|
4 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
2 years: missing values
|
2 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
3 years: Excellent
|
343 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
3 years: Very good
|
1499 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
3 years: Good
|
1309 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
3 years: Moderate
|
54 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
3 years: Sufficient
|
7 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
3 years: Insufficient
|
3 participants
|
—
|
—
|
—
|
—
|
|
Subject Assessment of Satisfaction With Xalatan® Treatment
3 years: missing values
|
2 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 year, 2 years, and 3 yearsPopulation: All subjects group and all treatment groups populations
Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to \>1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed.
Outcome measures
| Measure |
All Subjects
n=28812 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
n=13486 Participants
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
n=1884 Participants
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
n=746 Participants
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
n=12696 Participants
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Visual Acuity (Visus)
Baseline: Amaurosis
|
16 participants
|
4 participants
|
1 participants
|
1 participants
|
10 participants
|
|
Visual Acuity (Visus)
Baseline: Hand movements
|
503 participants
|
176 participants
|
28 participants
|
15 participants
|
284 participants
|
|
Visual Acuity (Visus)
Baseline: Finger count
|
241 participants
|
94 participants
|
15 participants
|
9 participants
|
123 participants
|
|
Visual Acuity (Visus)
1 year: 0.9
|
1152 participants
|
489 participants
|
5 participants
|
26 participants
|
224 participants
|
|
Visual Acuity (Visus)
1 year: 1.0
|
4687 participants
|
2242 participants
|
106 participants
|
78 participants
|
844 participants
|
|
Visual Acuity (Visus)
1 year: 1.1
|
39 participants
|
28 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Visual Acuity (Visus)
Baseline: 0.05
|
766 participants
|
238 participants
|
17 participants
|
26 participants
|
485 participants
|
|
Visual Acuity (Visus)
Baseline: 0.1
|
553 participants
|
194 participants
|
25 participants
|
11 participants
|
323 participants
|
|
Visual Acuity (Visus)
Baseline: 0.2
|
759 participants
|
308 participants
|
40 participants
|
12 participants
|
399 participants
|
|
Visual Acuity (Visus)
Baseline: 0.3
|
902 participants
|
355 participants
|
50 participants
|
27 participants
|
470 participants
|
|
Visual Acuity (Visus)
Baseline: 0.4
|
1345 participants
|
567 participants
|
62 participants
|
33 participants
|
683 participants
|
|
Visual Acuity (Visus)
Baseline: 0.5
|
2173 participants
|
941 participants
|
138 participants
|
56 participants
|
1038 participants
|
|
Visual Acuity (Visus)
Baseline: 0.6
|
2780 participants
|
1242 participants
|
217 participants
|
84 participants
|
1237 participants
|
|
Visual Acuity (Visus)
Baseline: 0.7
|
1799 participants
|
846 participants
|
107 participants
|
41 participants
|
805 participants
|
|
Visual Acuity (Visus)
Baseline: 0.8
|
4984 participants
|
2329 participants
|
395 participants
|
132 participants
|
2128 participants
|
|
Visual Acuity (Visus)
Baseline: 0.9
|
1880 participants
|
928 participants
|
130 participants
|
50 participants
|
772 participants
|
|
Visual Acuity (Visus)
Baseline: 1.0
|
8685 participants
|
4505 participants
|
613 participants
|
222 participants
|
3345 participants
|
|
Visual Acuity (Visus)
Baseline: 1.1
|
62 participants
|
42 participants
|
8 participants
|
1 participants
|
11 participants
|
|
Visual Acuity (Visus)
Baseline: 1.2
|
513 participants
|
258 participants
|
23 participants
|
13 participants
|
219 participants
|
|
Visual Acuity (Visus)
Baseline: >1.2
|
117 participants
|
77 participants
|
1 participants
|
5 participants
|
34 participants
|
|
Visual Acuity (Visus)
Baseline: Missing values
|
734 participants
|
382 participants
|
14 participants
|
8 participants
|
330 participants
|
|
Visual Acuity (Visus)
1 year: Amaurosis
|
9 participants
|
0 participants
|
0 participants
|
1 participants
|
4 participants
|
|
Visual Acuity (Visus)
1 year: Hand movements
|
319 participants
|
97 participants
|
1 participants
|
5 participants
|
153 participants
|
|
Visual Acuity (Visus)
1 year: Finger counts
|
179 participants
|
51 participants
|
5 participants
|
6 participants
|
79 participants
|
|
Visual Acuity (Visus)
1 year: 0.05
|
291 participants
|
86 participants
|
2 participants
|
9 participants
|
120 participants
|
|
Visual Acuity (Visus)
1 year: 0.1
|
238 participants
|
74 participants
|
3 participants
|
7 participants
|
79 participants
|
|
Visual Acuity (Visus)
1 year: 0.2
|
381 participants
|
127 participants
|
9 participants
|
4 participants
|
146 participants
|
|
Visual Acuity (Visus)
1 year: 0.3
|
484 participants
|
160 participants
|
9 participants
|
7 participants
|
180 participants
|
|
Visual Acuity (Visus)
1 year: 0.4
|
720 participants
|
270 participants
|
7 participants
|
13 participants
|
233 participants
|
|
Visual Acuity (Visus)
1 year: 0.5
|
1225 participants
|
463 participants
|
19 participants
|
23 participants
|
334 participants
|
|
Visual Acuity (Visus)
1 year: 0.6
|
1663 participants
|
625 participants
|
68 participants
|
38 participants
|
494 participants
|
|
Visual Acuity (Visus)
1 year: 0.7
|
1087 participants
|
418 participants
|
1 participants
|
23 participants
|
301 participants
|
|
Visual Acuity (Visus)
1 year: 0.8
|
2872 participants
|
1161 participants
|
116 participants
|
57 participants
|
697 participants
|
|
Visual Acuity (Visus)
1 year: 1.2
|
322 participants
|
152 participants
|
0 participants
|
5 participants
|
70 participants
|
|
Visual Acuity (Visus)
1 year: >1.2
|
52 participants
|
28 participants
|
1 participants
|
2 participants
|
5 participants
|
|
Visual Acuity (Visus)
1 year: Missing values
|
1384 participants
|
521 participants
|
14 participants
|
23 participants
|
555 participants
|
|
Visual Acuity (Visus)
2 years: Amaurosis
|
9 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Visual Acuity (Visus)
2 years: Hand movements
|
214 participants
|
53 participants
|
0 participants
|
2 participants
|
87 participants
|
|
Visual Acuity (Visus)
2 years: Finger counts
|
126 participants
|
31 participants
|
4 participants
|
1 participants
|
49 participants
|
|
Visual Acuity (Visus)
2 years: 0.05
|
191 participants
|
41 participants
|
0 participants
|
4 participants
|
80 participants
|
|
Visual Acuity (Visus)
2 years: 0.1
|
188 participants
|
52 participants
|
0 participants
|
3 participants
|
71 participants
|
|
Visual Acuity (Visus)
2 years: 0.2
|
263 participants
|
72 participants
|
4 participants
|
2 participants
|
90 participants
|
|
Visual Acuity (Visus)
2 years: 0.3
|
351 participants
|
111 participants
|
0 participants
|
3 participants
|
108 participants
|
|
Visual Acuity (Visus)
2 years: 0.4
|
470 participants
|
150 participants
|
3 participants
|
6 participants
|
145 participants
|
|
Visual Acuity (Visus)
2 years: 0.5
|
856 participants
|
309 participants
|
5 participants
|
14 participants
|
210 participants
|
|
Visual Acuity (Visus)
2 years: 0.6
|
1167 participants
|
385 participants
|
41 participants
|
16 participants
|
327 participants
|
|
Visual Acuity (Visus)
2 years: 0.7
|
738 participants
|
255 participants
|
2 participants
|
5 participants
|
162 participants
|
|
Visual Acuity (Visus)
2 years: 0.8
|
2051 participants
|
775 participants
|
63 participants
|
28 participants
|
424 participants
|
|
Visual Acuity (Visus)
2 years: 0.9
|
900 participants
|
352 participants
|
4 participants
|
9 participants
|
160 participants
|
|
Visual Acuity (Visus)
2 years 1.0
|
3437 participants
|
1607 participants
|
50 participants
|
33 participants
|
536 participants
|
|
Visual Acuity (Visus)
2 years: 1.1
|
29 participants
|
22 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Visual Acuity (Visus)
2 years: 1.2
|
234 participants
|
97 participants
|
0 participants
|
4 participants
|
41 participants
|
|
Visual Acuity (Visus)
2 years: >1.2
|
22 participants
|
7 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Visual Acuity (Visus)
2 years: Missing values
|
955 participants
|
335 participants
|
4 participants
|
7 participants
|
373 participants
|
|
Visual Acuity (Visus)
3 years: Amaurosis
|
4 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Visual Acuity (Visus)
3 years: Hand movements
|
133 participants
|
33 participants
|
2 participants
|
0 participants
|
47 participants
|
|
Visual Acuity (Visus)
3 years: Finger counts
|
82 participants
|
26 participants
|
0 participants
|
0 participants
|
26 participants
|
|
Visual Acuity (Visus)
3 years: 0.05
|
134 participants
|
26 participants
|
0 participants
|
2 participants
|
57 participants
|
|
Visual Acuity (Visus)
3 years: 0.1
|
137 participants
|
34 participants
|
3 participants
|
3 participants
|
43 participants
|
|
Visual Acuity (Visus)
3 years: 0.2
|
194 participants
|
53 participants
|
1 participants
|
1 participants
|
61 participants
|
|
Visual Acuity (Visus)
3 years: 0.3
|
227 participants
|
65 participants
|
4 participants
|
0 participants
|
74 participants
|
|
Visual Acuity (Visus)
3 years: 0.4
|
342 participants
|
107 participants
|
3 participants
|
5 participants
|
89 participants
|
|
Visual Acuity (Visus)
3 years: 0.5
|
606 participants
|
207 participants
|
8 participants
|
5 participants
|
136 participants
|
|
Visual Acuity (Visus)
3 years: 0.6
|
789 participants
|
258 participants
|
7 participants
|
9 participants
|
190 participants
|
|
Visual Acuity (Visus)
3 years: 0.7
|
534 participants
|
185 participants
|
3 participants
|
1 participants
|
111 participants
|
|
Visual Acuity (Visus)
3 years: 0.8
|
1369 participants
|
538 participants
|
16 participants
|
19 participants
|
260 participants
|
|
Visual Acuity (Visus)
3 years: 0.9
|
593 participants
|
210 participants
|
1 participants
|
3 participants
|
85 participants
|
|
Visual Acuity (Visus)
3 years: 1.0
|
2487 participants
|
1147 participants
|
16 participants
|
13 participants
|
347 participants
|
|
Visual Acuity (Visus)
3 years: 1.1
|
24 participants
|
18 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Visual Acuity (Visus)
3 years: 1.2
|
170 participants
|
61 participants
|
0 participants
|
1 participants
|
32 participants
|
|
Visual Acuity (Visus)
3 years: >1.2
|
13 participants
|
5 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Visual Acuity (Visus)
3 years: Missing values
|
662 participants
|
243 participants
|
0 participants
|
0 participants
|
258 participants
|
SECONDARY outcome
Timeframe: Baseline, 1 year, 2 years, and 3 yearsPopulation: All subjects group; not summarized by subgroups
Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment).
Outcome measures
| Measure |
All Subjects
n=28812 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Visual Impairment Due to Glaucoma
Baseline: Not at all
|
9368 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
Baseline: A little bit
|
5171 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
Baseline: Moderate
|
1723 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
Baseline: Severe
|
627 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
Baseline: Very severe
|
235 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
Baseline: Missing values
|
11688 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
1 year: Not at all
|
7184 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
1 year: A little bit
|
4269 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
1 year: Moderate
|
836 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
1 year: Severe
|
284 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
1 year: Very severe
|
91 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
1 year: Missing values
|
4440 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
2 years: Not at all
|
4917 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
2 years: A little bit
|
2961 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
2 years: Moderate
|
715 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
2 years: Severe
|
156 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
2 years: Very severe
|
50 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
2 years: Missing values
|
3402 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
3 years: Not at all
|
3120 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
3 years: A little bit
|
2137 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
3 years: Moderate
|
501 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
3 years: Severe
|
110 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
3 years: Very severe
|
48 participants
|
—
|
—
|
—
|
—
|
|
Visual Impairment Due to Glaucoma
3 years: Missing values
|
2584 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 year, 2 years, and 3 yearsPopulation: All subjects group; not summarized by subgroups
Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help).
Outcome measures
| Measure |
All Subjects
n=28812 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Subject Self-care: Application of Eye Drops
Baseline: apply without help
|
16520 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
Baseline: apply with help
|
1142 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
Baseline: missing values
|
11150 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
1 year: apply without help
|
12415 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
1 year: apply with help
|
919 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
1 year: missing values
|
3770 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
2 years: apply without help
|
8657 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
2 years: apply with help
|
391 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
2 years: missing values
|
3153 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
3 years: apply without help
|
5829 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
3 years: apply with help
|
265 participants
|
—
|
—
|
—
|
—
|
|
Subject Self-care: Application of Eye Drops
3 years: missing values
|
2406 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: January 2000 through December 2008Population: Subjects from the all subjects group that changed therapy through the duration of the study; subjects who changed from or changed to "other" therapy (Other Medication) were not included in this analysis; not summarized by subgroups.
Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study.
Outcome measures
| Measure |
All Subjects
n=8895 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Reasons for Changes in Glaucoma Therapy
Wish for better compliance
|
1055 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Changes in Glaucoma Therapy
Wish for stronger IOP decrease
|
3474 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Changes in Glaucoma Therapy
Wish for better local tolerability
|
787 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Changes in Glaucoma Therapy
Wish for better systemic tolerability
|
504 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Changes in Glaucoma Therapy
No medication until now
|
490 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Changes in Glaucoma Therapy
Other reason
|
284 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Changes in Glaucoma Therapy
Missing values
|
3859 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 3 yearsPopulation: Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).
Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data.
Outcome measures
| Measure |
All Subjects
n=13486 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
3 years: Insufficient
|
2 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
Baseline: Excellent
|
619 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
Baseline: Very good
|
1075 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
Baseline: Good
|
449 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
Baseline: Moderate
|
45 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
Baseline: Sufficient
|
4 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
Baseline: Insufficient
|
9 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
Baseline: Missing values
|
11285 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
1 year: Excellent
|
986 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
1 year: Very good
|
3429 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
1 year: Good
|
2437 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
1 year: Moderate
|
110 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
1 year: Sufficient
|
18 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
1 year: Insufficient
|
9 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
1 year: Missing values
|
3 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
2 years: Excellent
|
550 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
2 years: Very good
|
2203 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
2 years: Good
|
1795 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
2 years: Moderate
|
96 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
2 years: Sufficient
|
7 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
2 years: Insufficient
|
2 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
2 years: Missing values
|
2 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
3 years: Excellent
|
284 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
3 years: Very good
|
1571 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
3 years: Good
|
1281 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
3 years: Moderate
|
69 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
3 years: Sufficient
|
8 participants
|
—
|
—
|
—
|
—
|
|
Investigator Assessment of Tolerability of Xalatan® Treatment
3 years: Missing values
|
2 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: January 2000 through December 2008Population: Subjects from the All subjects group population who discontinued the study.
Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study.
Outcome measures
| Measure |
All Subjects
n=2427 Participants
Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
|
Xalatan®
Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
|
Betablockers
Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
|
Xalacom®
Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
|
Other Medications
Subjects with other or no hypotensive therapy at baseline visit.
|
|---|---|---|---|---|---|
|
Reasons for Discontinuation From Study
Lost to follow-up
|
717 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation From Study
Subject's death
|
589 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation From Study
Subject moved
|
320 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation From Study
Adverse event
|
337 participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation From Study
Other reason
|
302 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 3 yearsPopulation: Xalatan® treatment group (subjects with Xalatan® (latanoprost) monotherapy at baseline visit) and Xalacom® treatment group (latanoprost + timolol maleate) therapy at baseline visit. During the course of the study the data structure (scaling of color) was changed in a way that change in iris color was no longer evaluable; data not summarized.
Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®.
Outcome measures
Outcome data not reported
Adverse Events
All Subjects
Serious events: 0 serious events
Other events: 6936 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects
n=28812 participants at risk
Subjects with documented diagnosis of glaucoma or ocular hypertension at baseline visit.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Arrhythmia
|
0.76%
220/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Bradycardia
|
0.03%
9/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.03%
9/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Cyanosis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Palpitations
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Cardiac disorders
Tachycardia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Congenital, familial and genetic disorders
Anophthalmos
|
0.02%
6/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Congenital, familial and genetic disorders
Developmental glaucoma
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Congenital, familial and genetic disorders
Distichiasis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.02%
6/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Endocrine disorders
Goitre
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Abnormal sensation in eye
|
0.04%
12/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Accommodation disorder
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Acquired corneal dystrophy
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Amblyopia
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Anterior capsule contraction
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Anterior chamber disorder
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Asthenopia
|
0.01%
4/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Astigmatism
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Blepharitis
|
0.05%
15/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Cataract
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Chalazion
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.01%
4/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Conjunctival irritation
|
0.02%
7/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Conjunctival pigmentation
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Conjunctivitis
|
0.01%
4/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal decompensation
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal defect
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal disorder
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal epithelium defect
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal erosion
|
0.01%
4/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal hypertrophy
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal infiltrates
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal oedema
|
0.02%
5/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal opacity
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal pigmentation
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Corneal thinning
|
0.02%
5/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Cyanopsia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Dark circles under eyes
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Diplopia
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Dry eye
|
0.06%
16/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Ectropion
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eczema eyelids
|
0.02%
5/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Entropion
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Erythema of eyelid
|
0.05%
14/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eye discharge
|
0.02%
7/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eye inflammation
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eye irritation
|
7.8%
2252/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eye oedema
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eye pain
|
0.06%
17/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eye pruritus
|
0.11%
31/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eye swelling
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eyelash discolouration
|
0.03%
10/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eyelid oedema
|
0.02%
7/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eyelid sensory disorder
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Eyelids pruritus
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Foreign body sensation in eyes
|
4.0%
1150/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Growth of eyelashes
|
0.51%
148/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Hypermetropia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Hyphaema
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Hypoaesthesia eye
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Iris disorder
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Iris hyperpigmentation
|
0.07%
21/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Iris hypopigmentation
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Iritis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Keratitis
|
0.01%
4/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Keratoconjunctivitis sicca
|
0.01%
4/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Lacrimation increased
|
0.17%
50/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Macular degeneration
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Macular oedema
|
0.03%
9/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Maculopathy
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Miosis
|
0.19%
56/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Mydriasis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Myodesopsia
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Myopia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Night blindness
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Ocular hyperaemia
|
13.1%
3760/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Optic disc haemorrhage
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Optic nerve cupping
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Photophobia
|
0.02%
5/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Photopsia
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Presbyopia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Pterygium
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Punctate keratitis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Pupils unequal
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Retinal haemorrhage
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Scleral discolouration
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Scotoma
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Sicca syndrome
|
0.13%
37/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Strabismus
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Trichiasis
|
0.01%
4/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Vision blurred
|
0.06%
17/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Visual impairment
|
0.08%
22/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Eye disorders
Vitreous opacities
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.07%
20/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Gastrointestinal disorders
Nausea
|
0.68%
197/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Gastrointestinal disorders
Tongue dry
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
General disorders
Adverse drug reaction
|
0.05%
14/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
General disorders
Asthenia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
General disorders
Chest pain
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
General disorders
Death
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
General disorders
Drug ineffective
|
0.01%
4/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
General disorders
Drug intolerance
|
0.02%
5/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
General disorders
Fatigue
|
5.2%
1510/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
General disorders
Mucosal dryness
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
General disorders
Oedema peripheral
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Immune system disorders
Corneal graft rejection
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Immune system disorders
Drug hypersensitivity
|
3.0%
873/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Immune system disorders
Multiple allergies
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Immune system disorders
Reaction to preservatives
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Infections and infestations
Adenoviral conjunctivitis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Infections and infestations
Bronchitis
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Injury, poisoning and procedural complications
Corneal scar
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Investigations
Blood pressure decreased
|
0.01%
4/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Investigations
Blood pressure increased
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Investigations
Heart rate decreased
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Investigations
Intraocular pressure decreased
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Investigations
Intraocular pressure fluctuation
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Investigations
Thyroid function test normal
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Investigations
Weight decreased
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Balance disorder
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Cerebrosclerosis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.02%
6/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Dementia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Dizziness
|
0.17%
48/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Dysgeusia
|
0.06%
17/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Headache
|
1.5%
431/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Memory impairment
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Paraesthesia
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Senile dementia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Affect lability
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Anxiety
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Confusional state
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Depression
|
0.06%
17/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Mental disorder
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Neurosis
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Psychiatric disorders
Sleep disorder
|
0.03%
8/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
8/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.71%
204/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
5/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.07%
20/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.02%
6/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.03%
10/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.03%
9/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Social circumstances
Treatment noncompliance
|
0.08%
22/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Surgical and medical procedures
Corneal transplant
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Surgical and medical procedures
Eye excision
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Surgical and medical procedures
Eye laser surgery
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Surgical and medical procedures
Eye operation
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Surgical and medical procedures
Eye prosthesis insertion
|
0.01%
3/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Surgical and medical procedures
Photocoagulation
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Vascular disorders
Angiosclerosis
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Vascular disorders
Circulatory collapse
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Vascular disorders
Embolism
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Vascular disorders
Hypertension
|
0.02%
7/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Vascular disorders
Hypotension
|
0.03%
8/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Vascular disorders
Peripheral coldness
|
0.01%
2/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
1/28812 • Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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