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Trial record 76 of 81 for:    CRVO - Central Retinal Vein Occlusion

The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study (SCORE)

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ClinicalTrials.gov Identifier: NCT00105027
Recruitment Status : Completed
First Posted : March 4, 2005
Results First Posted : January 19, 2011
Last Update Posted : July 2, 2018
Sponsor:
Collaborators:
National Eye Institute (NEI)
Allergan
Information provided by (Responsible Party):
The EMMES Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Macular Edema, Cystoid
Retinal Vein Occlusion
Interventions Other: Standard Care
Drug: intravitreal triamcinolone injection
Enrollment 682
Recruitment Details

Between November 8, 2004, and February 29, 2008, 271 patients with central retinal vein occlusion (CRVO) were enrolled from 66 clinical sites and 411 patients with branch retinal vein occlusion (BRVO) were enrolled from 75 clinical sites across the United States.

Participant flow data are reported for the primary outcome measure (12 months).

Pre-assignment Details  
Arm/Group Title CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide
Hide Arm/Group Description Standard care consists of observation of the macular edema. Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Period Title: Overall Study
Started 88 92 91 137 136 138
Completed 73 83 82 121 121 125
Not Completed 15 9 9 16 15 13
Arm/Group Title CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide Total
Hide Arm/Group Description Standard care consists of observation of the macular edema. Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Total of all reporting groups
Overall Number of Baseline Participants 88 92 91 137 136 138 682
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants 682 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  28.4%
35
  38.0%
34
  37.4%
62
  45.3%
54
  39.7%
55
  39.9%
265
  38.9%
>=65 years
63
  71.6%
57
  62.0%
57
  62.6%
75
  54.7%
82
  60.3%
83
  60.1%
417
  61.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants 682 participants
69.2  (12.8) 67.4  (12.4) 67.5  (12.0) 66.9  (11.5) 67.2  (11.5) 68.1  (10.6) 67.7  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants 682 participants
Female
40
  45.5%
43
  46.7%
40
  44.0%
71
  51.8%
68
  50.0%
63
  45.7%
325
  47.7%
Male
48
  54.5%
49
  53.3%
51
  56.0%
66
  48.2%
68
  50.0%
75
  54.3%
357
  52.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants 682 participants
88 92 91 137 136 138 682
1.Primary Outcome
Title The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit
Hide Description Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.
Time Frame Change from baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide
Hide Arm/Group Description:
Standard care consists of observation of the macular edema.
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Overall Number of Participants Analyzed 88 92 91 137 136 138
Measure Type: Number
Unit of Measure: Participants
5 22 21 35 31 34
2.Secondary Outcome
Title Changes From Baseline in Best-corrected ETDRS Visual Acuity Score
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who attended month 12 visit
Arm/Group Title CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide
Hide Arm/Group Description:
Standard care consists of observation of the macular edema.
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Overall Number of Participants Analyzed 73 83 82 121 121 125
Mean (95% Confidence Interval)
Unit of Measure: letters read
-12.1
(-17.1 to -7.1)
-1.2
(-6.4 to 4.1)
-1.2
(-6.3 to 4.0)
4.2
(1.1 to 7.3)
5.7
(2.8 to 8.6)
4.0
(0.9 to 7.2)
3.Secondary Outcome
Title Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who attended month 12 visit
Arm/Group Title CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide
Hide Arm/Group Description:
Standard care consists of observation of the macular edema.
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Overall Number of Participants Analyzed 68 72 78 120 113 112
Median (Inter-Quartile Range)
Unit of Measure: um
-277
(-418 to -40)
-196
(-390 to -62)
-261
(-407 to -79)
-224
(-411 to -67)
-149
(-279 to -18)
-170
(-304 to -63)
4.Secondary Outcome
Title Adverse Ocular Outcomes
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants experiencing an adverse event
Arm/Group Title CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide
Hide Arm/Group Description:
Standard care consists of observation of the macular edema.
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
Overall Number of Participants Analyzed 88 92 91 137 136 138
Measure Type: Number
Unit of Measure: events
Initiation of IOP-lowering medications Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
7 18 32 3 11 57
IOP > 35 mm HG Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
1 5 8 1 2 14
IOP > 10 mm HG above baseline Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
2 15 24 1 12 50
Laser peripheral iridotomy Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
0 0 1 0 0 1
Trabeculectomy Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
0 0 0 0 0 0
Tube shunt Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
0 2 0 0 0 0
Cataract: lens opacity onset or progression Number Analyzed 66 participants 77 participants 76 participants 115 participants 110 participants 110 participants
12 20 25 15 27 38
Cataract surgery Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
0 0 4 3 0 4
Infectious endophthalmitis Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
0 0 0 0 0 1
Noninfectious endophthalmitis Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
0 0 0 0 0 0
Retinal detachment Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
0 0 0 1 1 0
Iris neovascularization Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
2 9 4 1 1 2
Retinal neovascularization Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
4 2 2 5 1 3
Vitreous hemorrhage Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
4 4 0 2 1 3
YAG capsulotomy Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
1 0 0 1 0 1
Sector or panretinal photocagulation Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
5 9 3 5 1 4
Pars plana vitrectomy Number Analyzed 88 participants 92 participants 91 participants 137 participants 136 participants 138 participants
1 2 0 1 0 1
Time Frame Three years
Adverse Event Reporting Description Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
 
Arm/Group Title CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide
Hide Arm/Group Description Standard care consists of observation of the macular edema. Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
All-Cause Mortality
CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/88 (0.00%)      1/92 (1.09%)      2/91 (2.20%)      3/137 (2.19%)      2/136 (1.47%)      2/138 (1.45%)    
Show Serious Adverse Events Hide Serious Adverse Events
CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/88 (36.36%)      37/92 (40.22%)      53/91 (58.24%)      47/137 (34.31%)      49/136 (36.03%)      79/138 (57.25%)    
Blood and lymphatic system disorders             
Anaemia  1  0/88 (0.00%)  0 1/92 (1.09%)  2 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Cardiac disorders             
Angina pectoris  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Angina unstable  1  3/88 (3.41%)  3 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Atrial fibrillation  1  0/88 (0.00%)  0 2/92 (2.17%)  2 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Atrioventricular block  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Cardiac arrest  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Cardiac disorder  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Cardiac failure  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Cardiac failure congestive  1  1/88 (1.14%)  1 2/92 (2.17%)  2 2/91 (2.20%)  2 1/137 (0.73%)  1 0/136 (0.00%)  0 2/138 (1.45%)  2
Cardiomyopathy  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Cardiovascular disorder  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Coronary artery disease  1  2/88 (2.27%)  2 1/92 (1.09%)  2 0/91 (0.00%)  0 1/137 (0.73%)  1 1/136 (0.74%)  1 2/138 (1.45%)  2
Myocardial infarction  1  0/88 (0.00%)  0 1/92 (1.09%)  1 2/91 (2.20%)  2 0/137 (0.00%)  0 2/136 (1.47%)  2 2/138 (1.45%)  2
Palpitations  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Sick sinus syndrome  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Sinus bradycardia  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Eye disorders             
Angle closure glaucoma  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 1/136 (0.74%)  1 1/138 (0.72%)  1
Anisometropia  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Anterior chamber disorder  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Cataract  1  5/88 (5.68%)  5 9/92 (9.78%)  10 28/91 (30.77%)  30 12/137 (8.76%)  16 16/136 (11.76%)  18 40/138 (28.99%)  46
Cataract cortical  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 2/138 (1.45%)  2
Cataract nuclear  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 1/138 (0.72%)  1
Cataract subcapsular  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 1/137 (0.73%)  1 1/136 (0.74%)  1 12/138 (8.70%)  12
Choroidal neovascularisation  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Endophthalmitis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Eye pain  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Glaucoma  1  1/88 (1.14%)  1 5/92 (5.43%)  5 3/91 (3.30%)  3 0/137 (0.00%)  0 0/136 (0.00%)  0 2/138 (1.45%)  3
Iris neovascularisation  1  1/88 (1.14%)  1 2/92 (2.17%)  2 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Macular degeneration  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Macular hole  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Maculopathy  1  0/88 (0.00%)  0 1/92 (1.09%)  1 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Ocular hypertension  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Optic nerve cupping  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Posterior capsule opacification  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 2/137 (1.46%)  2 2/136 (1.47%)  2 0/138 (0.00%)  0
Retinal detachment  1  0/88 (0.00%)  0 2/92 (2.17%)  2 0/91 (0.00%)  0 0/137 (0.00%)  0 2/136 (1.47%)  2 1/138 (0.72%)  1
Retinal neovascularisation  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Retinal tear  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Retinal vein occlusion  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Retinopathy proliferative  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Uveitis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Vitreous haemorrhage  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 1/138 (0.72%)  1
Vitreous prolapse  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Gastrointestinal disorders             
Abdominal hernia  1  1/88 (1.14%)  1 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Ascites  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Colitis ischaemic  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Constipation  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Diarrhoea  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Diverticular hernia  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Dysphagia  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Gastritis  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Gastrointestinal haemorrhage  1  1/88 (1.14%)  1 0/92 (0.00%)  0 2/91 (2.20%)  2 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Gastrointestinal oedema  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Haematochezia  1  1/88 (1.14%)  1 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Haemorrhoids  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Inguinal hernia  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Inguinal hernia, obstructive  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Intestinal haemorrhage  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Intestinal obstruction  1  0/88 (0.00%)  0 1/92 (1.09%)  1 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Large intestine perforation  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Pancreatitis  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Peritonitis  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Rectal haemorrhage  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Small intestinal obstruction  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
General disorders             
Asthenia  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Chest discomfort  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Chest pain  1  1/88 (1.14%)  1 1/92 (1.09%)  2 0/91 (0.00%)  0 3/137 (2.19%)  3 1/136 (0.74%)  1 2/138 (1.45%)  2
Death  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Non-cardiac chest pain  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Polyp  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Pyrexia  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Hepatobiliary disorders             
Cholecystitis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Cholecystitis acute  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Cholelithiasis  1  0/88 (0.00%)  0 1/92 (1.09%)  1 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 2/138 (1.45%)  2
Gallbladder pain  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Hepatic failure  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Hepatomegaly  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Immune system disorders             
Drug hypersensitivity  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Infections and infestations             
Abdominal wall abscess  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Arthritis bacterial  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Bronchitis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Cellulitis  1  2/88 (2.27%)  2 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 2/136 (1.47%)  3 1/138 (0.72%)  1
Chronic sinusitis  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Clostridial infection  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Cystitis  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Diverticulitis  1  0/88 (0.00%)  0 2/92 (2.17%)  2 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 1/138 (0.72%)  1
Gastroenteritis  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Gastroenteritis viral  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Infection  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Lung infection  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Pneumonia  1  2/88 (2.27%)  2 2/92 (2.17%)  2 0/91 (0.00%)  0 1/137 (0.73%)  1 4/136 (2.94%)  4 2/138 (1.45%)  2
Sepsis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Sinusitis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Staphylococcal infection  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Urinary tract infection  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  2 0/138 (0.00%)  0
Injury, poisoning and procedural complications             
Ankle fracture  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Arthropod bite  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Cartilage injury  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 1/138 (0.72%)  1
Concussion  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Conjunctival filtering bleb leak  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Corneal abrasion  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Drug toxicity  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Facial bones fracture  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Fall  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Femur fracture  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Foot fracture  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 1/138 (0.72%)  1
Gastroenteritis radiation  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Head injury  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Heat stroke  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Hip fracture  1  1/88 (1.14%)  2 0/92 (0.00%)  0 1/91 (1.10%)  1 1/137 (0.73%)  1 0/136 (0.00%)  0 1/138 (0.72%)  1
Injury  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Joint injury  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Lower limb fracture  1  1/88 (1.14%)  1 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Rib fracture  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Skeletal injury  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Spinal fracture  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Vascular procedure complication  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Investigations             
Blood glucose increased  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Blood pressure increased  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Heart rate decreased  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Heart rate increased  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Heart rate irregular  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Intraocular pressure increased  1  3/88 (3.41%)  4 2/92 (2.17%)  3 3/91 (3.30%)  3 0/137 (0.00%)  0 0/136 (0.00%)  0 4/138 (2.90%)  4
Metabolism and nutrition disorders             
Dehydration  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Electrolyte imbalance  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Hyponatraemia  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/88 (0.00%)  0 0/92 (0.00%)  0 2/91 (2.20%)  2 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Arthritis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Arthropathy  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Back pain  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Cervical spinal stenosis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Intervertebral disc protrusion  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  2 0/138 (0.00%)  0
Joint effusion  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Muscle twitching  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Musculoskeletal pain  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 1/138 (0.72%)  2
Osteoarthritis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 2/137 (1.46%)  2 1/136 (0.74%)  2 0/138 (0.00%)  0
Rotator cuff syndrome  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 1/136 (0.74%)  1 0/138 (0.00%)  0
Spinal column stenosis  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Benign colonic neoplasm  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Bladder cancer  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 3/137 (2.19%)  3 0/136 (0.00%)  0 0/138 (0.00%)  0
Bone cancer metastatic  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Breast cancer  1  1/88 (1.14%)  1 1/92 (1.09%)  1 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Colon cancer  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Endometrial cancer  1  0/88 (0.00%)  0 1/92 (1.09%)  2 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Hepatic neoplasm malignant  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Lung neoplasm malignant  1  0/88 (0.00%)  0 0/92 (0.00%)  0 3/91 (3.30%)  3 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Malignant melanoma  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Mantle cell lymphoma  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Multiple myeloma  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Neuroendocrine tumour  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Pancreatic carcinoma  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 1/138 (0.72%)  1
Prostate cancer  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Renal cancer metastatic  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Spinal cord neoplasm  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
T-cell lymphoma  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Throat cancer  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Uterine leiomyoma  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 2/137 (1.46%)  2 0/136 (0.00%)  0 0/138 (0.00%)  0
Nervous system disorders             
Brain stem infarction  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Carotid artery disease  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Carotid artery stenosis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Central nervous system lesion  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Cerebellar haemorrhage  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Cerebral haemorrhage  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Cerebrovascular accident  1  2/88 (2.27%)  2 0/92 (0.00%)  0 4/91 (4.40%)  5 3/137 (2.19%)  3 1/136 (0.74%)  1 3/138 (2.17%)  3
Dizziness  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  3 0/138 (0.00%)  0
Haemorrhage intracranial  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Lumbar radiculopathy  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Paraesthesia  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Presyncope  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Syncope  1  0/88 (0.00%)  0 0/92 (0.00%)  0 3/91 (3.30%)  3 1/137 (0.73%)  1 1/136 (0.74%)  1 0/138 (0.00%)  0
Transient ischaemic attack  1  2/88 (2.27%)  2 0/92 (0.00%)  0 0/91 (0.00%)  0 2/137 (1.46%)  2 0/136 (0.00%)  0 0/138 (0.00%)  0
Psychiatric disorders             
Alcoholism  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Anxiety  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Renal and urinary disorders             
Automatic bladder  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Bladder disorder  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Haematuria  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Incontinence  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Nephrolithiasis  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Renal failure  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Renal failure acute  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 1/138 (0.72%)  1
Renal failure chronic  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Renal impairment  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Urinary retention  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Reproductive system and breast disorders             
Benign prostatic hyperplasia  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 2/136 (1.47%)  2 0/138 (0.00%)  0
Cystocele  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Prostatic mass  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Uterine haemorrhage  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease  1  0/88 (0.00%)  0 1/92 (1.09%)  2 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Cough  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Dyspnoea  1  1/88 (1.14%)  1 1/92 (1.09%)  1 2/91 (2.20%)  4 2/137 (1.46%)  2 0/136 (0.00%)  0 2/138 (1.45%)  2
Hypoxia  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Pleural effusion  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Pulmonary embolism  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Pulmonary fibrosis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Respiratory failure  1  0/88 (0.00%)  0 1/92 (1.09%)  1 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Surgical and medical procedures             
Cardiac pacemaker insertion  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Coronary arterial stent insertion  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Finger amputation  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 0/138 (0.00%)  0
Hip arthroplasty  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Knee arthroplasty  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Nephrectomy  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Vascular graft  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 1/136 (0.74%)  1 1/138 (0.72%)  1
Vascular disorders             
Aortic aneurysm  1  0/88 (0.00%)  0 0/92 (0.00%)  0 1/91 (1.10%)  1 0/137 (0.00%)  0 2/136 (1.47%)  2 0/138 (0.00%)  0
Aortic dissection  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Aortic stenosis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 0/136 (0.00%)  0 0/138 (0.00%)  0
Arteriosclerosis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 1/138 (0.72%)  1
Deep vein thrombosis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 2/138 (1.45%)  2
Hypotension  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Peripheral vascular disorder  1  1/88 (1.14%)  1 0/92 (0.00%)  0 0/91 (0.00%)  0 0/137 (0.00%)  0 0/136 (0.00%)  0 0/138 (0.00%)  0
Thrombosis  1  0/88 (0.00%)  0 0/92 (0.00%)  0 0/91 (0.00%)  0 1/137 (0.73%)  1 1/136 (0.74%)  1 0/138 (0.00%)  0
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CRVO Observation CRVO 1 mg Dose Triamcinolone Acetonide CRVO 4 mg Dose Triamcinolone Acetonide BRVO Standard Care BRVO 1 mg Dose Triamcinolone Acetonide BRVO 4 mg Dose Triamcinolone Acetonide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/88 (86.36%)      87/92 (94.57%)      89/91 (97.80%)      118/137 (86.13%)      132/136 (97.06%)      133/138 (96.38%)    
Eye disorders             
Blepharitis  1  0/88 (0.00%)  0 3/92 (3.26%)  5 8/91 (8.79%)  19 4/137 (2.92%)  8 9/136 (6.62%)  16 6/138 (4.35%)  11
Cataract  1  10/88 (11.36%)  14 9/92 (9.78%)  12 14/91 (15.38%)  16 15/137 (10.95%)  27 19/136 (13.97%)  28 21/138 (15.22%)  25
Cataract subcapsular  1  3/88 (3.41%)  3 8/92 (8.70%)  8 12/91 (13.19%)  12 2/137 (1.46%)  3 13/136 (9.56%)  14 16/138 (11.59%)  18
Conjunctival haemorrhage  1  3/88 (3.41%)  7 34/92 (36.96%)  54 30/91 (32.97%)  57 9/137 (6.57%)  9 54/136 (39.71%)  88 54/138 (39.13%)  82
Dry eye  1  3/88 (3.41%)  6 3/92 (3.26%)  5 2/91 (2.20%)  3 5/137 (3.65%)  12 7/136 (5.15%)  13 6/138 (4.35%)  10
Eye irritation  1  2/88 (2.27%)  2 11/92 (11.96%)  12 9/91 (9.89%)  14 6/137 (4.38%)  8 17/136 (12.50%)  28 8/138 (5.80%)  9
Eye pain  1  6/88 (6.82%)  6 15/92 (16.30%)  25 18/91 (19.78%)  36 9/137 (6.57%)  13 23/136 (16.91%)  34 18/138 (13.04%)  26
Eyelid ptosis  1  0/88 (0.00%)  0 1/92 (1.09%)  1 6/91 (6.59%)  8 5/137 (3.65%)  7 0/136 (0.00%)  0 10/138 (7.25%)  11
Foreign body sensation in eyes  1  4/88 (4.55%)  5 8/92 (8.70%)  8 3/91 (3.30%)  3 1/137 (0.73%)  1 13/136 (9.56%)  13 12/138 (8.70%)  14
Glaucoma  1  1/88 (1.14%)  1 1/92 (1.09%)  1 5/91 (5.49%)  5 2/137 (1.46%)  3 1/136 (0.74%)  2 6/138 (4.35%)  7
Iris neovascularisation  1  2/88 (2.27%)  2 6/92 (6.52%)  7 3/91 (3.30%)  3 0/137 (0.00%)  0 2/136 (1.47%)  2 1/138 (0.72%)  2
Lacrimation increased  1  1/88 (1.14%)  1 5/92 (5.43%)  6 4/91 (4.40%)  7 5/137 (3.65%)  8 5/136 (3.68%)  7 6/138 (4.35%)  7
Macular oedema  1  2/88 (2.27%)  2 6/92 (6.52%)  6 2/91 (2.20%)  2 3/137 (2.19%)  3 3/136 (2.21%)  3 1/138 (0.72%)  1
Maculopathy  1  5/88 (5.68%)  5 9/92 (9.78%)  10 10/91 (10.99%)  10 9/137 (6.57%)  10 12/136 (8.82%)  14 9/138 (6.52%)  10
Myodesopsia  1  8/88 (9.09%)  9 32/92 (34.78%)  44 34/91 (37.36%)  52 17/137 (12.41%)  23 59/136 (43.38%)  81 45/138 (32.61%)  64
Photopsia  1  3/88 (3.41%)  3 7/92 (7.61%)  8 4/91 (4.40%)  4 5/137 (3.65%)  6 10/136 (7.35%)  11 5/138 (3.62%)  6
Retinal haemorrhage  1  1/88 (1.14%)  1 6/92 (6.52%)  6 1/91 (1.10%)  2 4/137 (2.92%)  5 1/136 (0.74%)  1 2/138 (1.45%)  2
Retinal neovascularisation  1  6/88 (6.82%)  6 4/92 (4.35%)  4 6/91 (6.59%)  6 6/137 (4.38%)  8 1/136 (0.74%)  1 5/138 (3.62%)  5
Retinal vascular disorder  1  0/88 (0.00%)  0 6/92 (6.52%)  6 1/91 (1.10%)  2 2/137 (1.46%)  2 4/136 (2.94%)  4 3/138 (2.17%)  3
Retinal vein occlusion  1  4/88 (4.55%)  4 4/92 (4.35%)  4 3/91 (3.30%)  3 6/137 (4.38%)  6 3/136 (2.21%)  3 8/138 (5.80%)  10
Vision blurred  1  5/88 (5.68%)  6 6/92 (6.52%)  11 9/91 (9.89%)  13 14/137 (10.22%)  19 15/136 (11.03%)  19 17/138 (12.32%)  22
Visual acuity reduced  1  10/88 (11.36%)  10 12/92 (13.04%)  14 10/91 (10.99%)  15 6/137 (4.38%)  11 11/136 (8.09%)  12 13/138 (9.42%)  15
Visual impairment  1  5/88 (5.68%)  5 5/92 (5.43%)  5 3/91 (3.30%)  4 11/137 (8.03%)  14 9/136 (6.62%)  10 7/138 (5.07%)  10
Vitreous detachment  1  8/88 (9.09%)  9 16/92 (17.39%)  19 10/91 (10.99%)  12 15/137 (10.95%)  20 21/136 (15.44%)  25 12/138 (8.70%)  14
Vitreous haemorrhage  1  7/88 (7.95%)  7 8/92 (8.70%)  8 2/91 (2.20%)  2 2/137 (1.46%)  2 5/136 (3.68%)  5 5/138 (3.62%)  5
Infections and infestations             
Bronchitis  1  1/88 (1.14%)  1 3/92 (3.26%)  4 5/91 (5.49%)  6 5/137 (3.65%)  6 3/136 (2.21%)  3 4/138 (2.90%)  4
Nasopharyngitis  1  0/88 (0.00%)  0 2/92 (2.17%)  3 6/91 (6.59%)  7 8/137 (5.84%)  8 5/136 (3.68%)  6 9/138 (6.52%)  10
Injury, poisoning and procedural complications             
Foreign body in eye  1  5/88 (5.68%)  5 31/92 (33.70%)  31 22/91 (24.18%)  22 4/137 (2.92%)  4 67/136 (49.26%)  67 31/138 (22.46%)  31
Investigations             
Intraocular pressure increased  1  8/88 (9.09%)  10 20/92 (21.74%)  24 42/91 (46.15%)  55 7/137 (5.11%)  9 19/136 (13.97%)  24 64/138 (46.38%)  88
Metabolism and nutrition disorders             
Hypercholesterolaemia  1  4/88 (4.55%)  4 1/92 (1.09%)  1 5/91 (5.49%)  5 4/137 (2.92%)  4 6/136 (4.41%)  6 6/138 (4.35%)  7
Nervous system disorders             
Headache  1  6/88 (6.82%)  6 5/92 (5.43%)  5 7/91 (7.69%)  8 4/137 (2.92%)  4 4/136 (2.94%)  6 5/138 (3.62%)  9
Respiratory, thoracic and mediastinal disorders             
Cough  1  0/88 (0.00%)  0 5/92 (5.43%)  5 1/91 (1.10%)  1 1/137 (0.73%)  1 6/136 (4.41%)  6 4/138 (2.90%)  4
Vascular disorders             
Hypertension  1  2/88 (2.27%)  2 2/92 (2.17%)  2 4/91 (4.40%)  4 6/137 (4.38%)  6 12/136 (8.82%)  12 12/138 (8.70%)  12
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Paul C. VanVeldhuisen, Ph.D.
Organization: The EMMES Corporation
Phone: 301-251-1161
Other Publications:
Responsible Party: The EMMES Corporation
ClinicalTrials.gov Identifier: NCT00105027     History of Changes
Other Study ID Numbers: NEI-99
5U10EY014351-05 ( U.S. NIH Grant/Contract )
5U10EY014404 ( U.S. NIH Grant/Contract )
5U10EY014352 ( U.S. NIH Grant/Contract )
First Submitted: March 3, 2005
First Posted: March 4, 2005
Results First Submitted: November 9, 2010
Results First Posted: January 19, 2011
Last Update Posted: July 2, 2018