Trial Outcomes & Findings for Comparison of Treatment Regimens Using Ranibizumab: Intensive (Resolution of Intra- and Sub-retinal Fluid) vs Relaxed (Resolution of Intra-retinal Fluid and/or Sub-retinal Fluid >200µm at the Foveal Centre) (NCT NCT01972789)
NCT ID: NCT01972789
Last Updated: 2019-10-23
Results Overview
Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 24.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
349 participants
Primary outcome timeframe
Baseline to month 24
Results posted on
2019-10-23
Participant Flow
a total of 349 subjects were randomized to the study (intensive arm, 174; relaxed arm, 175). relaxed 173).
Two randomized subjects, 1 in each treatment group, did not receive study treatment and were excluded from the safety set (347 subjects: intensive arm, 173; relaxed arm, 174). 2 subjects did not have correctly measured BCVA at baseline and were excluded from the FAS (345 subjects: intensive 172;
Participant milestones
| Measure |
Intensive Retinal Fluid Regimen
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Overall Study
STARTED
|
174
|
175
|
|
Overall Study
COMPLETED
|
134
|
145
|
|
Overall Study
NOT COMPLETED
|
40
|
30
|
Reasons for withdrawal
| Measure |
Intensive Retinal Fluid Regimen
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
4
|
|
Overall Study
Subject withdrew consent
|
14
|
12
|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
|
Overall Study
Death
|
7
|
5
|
|
Overall Study
Protocol deviation
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
2
|
Baseline Characteristics
Comparison of Treatment Regimens Using Ranibizumab: Intensive (Resolution of Intra- and Sub-retinal Fluid) vs Relaxed (Resolution of Intra-retinal Fluid and/or Sub-retinal Fluid >200µm at the Foveal Centre)
Baseline characteristics by cohort
| Measure |
Intensive Retinal Fluid Regimen
n=174 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=175 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.3 Years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
78.8 Years
STANDARD_DEVIATION 8.17 • n=7 Participants
|
79 Years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
163 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to month 24Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 24.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.
|
3.2 Letters
Standard Deviation 16.51
|
2.5 Letters
Standard Deviation 16.56
|
SECONDARY outcome
Timeframe: Baseline to month 12Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 12.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Mean Change in BCVA From Baseline to Month 12.
|
4.6 Letters
Standard Deviation 14.69
|
3.9 Letters
Standard Deviation 12.73
|
SECONDARY outcome
Timeframe: Baseline to month 12 and month 24Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
Central retinal thickness will be measured by Optical Coherence Tomography (OCT) at every visit.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.
Month 12
|
-147.1 μm
Standard Deviation 168.33
|
-125.6 μm
Standard Deviation 133.08
|
|
Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.
Month 24
|
-158.9 μm
Standard Deviation 170.44
|
-126.9 μm
Standard Deviation 140.01
|
SECONDARY outcome
Timeframe: Baseline to month 12 to month 24.Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
The number of injections will be determined by the individual patient response to ranibizumab therapy and potential for extension between injections based on specific criteria: loss of visual acuity, new retinal haemorrhage, and presence of IRF or SRF on OCT.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Mean Number of Injections From Baseline to Month 12 and 24
Month 12
|
9.5 Injections
Standard Deviation 2.60
|
8.9 Injections
Standard Deviation 2.25
|
|
Mean Number of Injections From Baseline to Month 12 and 24
Month 24
|
17 Injections
Standard Deviation 6.48
|
15.8 Injections
Standard Deviation 5.91
|
SECONDARY outcome
Timeframe: Baseline to months 12 and 24.Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
Autofluorescence will be measured by multimodal imaging to assess the presence and development of geographic atrophy in the study at baseline, and month 12 and 24.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.
Month 12
|
0.8 mm^2
Standard Deviation 2.13
|
0.7 mm^2
Standard Deviation 1.80
|
|
Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.
Month 24
|
1.5 mm^2
Standard Deviation 3.18
|
1.2 mm^2
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
A multimodal imaging approach will be used to assess the presence of new geographic atrophy (defined as incorporating both geographic atrophy and atrophy associated with the CNV) in the study eye at baseline, and month 12 and 24. Image modalities will include fundus autofluorescence (AF) imaging, infrared imaging, OCT and colour fundus (CF) photographs. Atrophy will be diagnosed if FA and one other modality confirm the presence of macular atrophy
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24
Month 24, GA absent
|
80 Participants
|
94 Participants
|
|
Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24
Month 12, GA present
|
25 Participants
|
18 Participants
|
|
Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24
Month 12, GA absent
|
103 Participants
|
110 Participants
|
|
Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24
Month 24, GA present
|
32 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Months 2, 12 and 24.Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.
Month 2
|
106 Participants
|
93 Participants
|
|
Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.
month 12
|
87 Participants
|
72 Participants
|
|
Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.
Month 24
|
64 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Baseline to months 12 and 24.Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and months 2, 12 and 24.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24.
Month 12
|
29 Participants
|
24 Participants
|
|
Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24.
Month 24
|
25 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to months 12 and 24Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
Best-corrected visual acuity with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and months 2, 12 and 24.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.
Month 12
|
142 Participants
|
141 Participants
|
|
Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.
Month 24
|
129 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: Baseline or following consentPopulation: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
DNA will be extracted from saliva and genotyping performed on the significantly associated single nucleotide polymorphisms (SNPs) identified by the AMD Gene Consortium (Nature Genetics, March 2013). Genotypes will be derived through the use of a Sequenom Iplex protocol. No correlation analyses were performed.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS10490924 GG
|
44 Participants
|
47 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS10490924 GT
|
56 Participants
|
57 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS8135665 CT
|
50 Participants
|
41 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS8135665 TT
|
6 Participants
|
7 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS10490924 TT
|
24 Participants
|
23 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS1061170 CC
|
35 Participants
|
43 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS1061170 CT
|
61 Participants
|
61 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS1061170 TT
|
29 Participants
|
21 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS10737680 AA
|
68 Participants
|
82 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS10737680 AC
|
48 Participants
|
37 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS10737680 CC
|
9 Participants
|
8 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS11200638 AA
|
21 Participants
|
23 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS11200638 AG
|
58 Participants
|
58 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS11200638 GG
|
46 Participants
|
46 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS121913059 CC
|
124 Participants
|
127 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS121913059 CT
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS13278062 GG
|
29 Participants
|
17 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS13278062 GT
|
60 Participants
|
75 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS13278062 TT
|
36 Participants
|
35 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS141853578 CC
|
125 Participants
|
125 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS920915 CC
|
32 Participants
|
33 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS147859257 GT
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS147859257 TT
|
123 Participants
|
126 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS1864163 AA
|
9 Participants
|
7 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS1864163 AG
|
29 Participants
|
46 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS1864163 GG
|
85 Participants
|
73 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS2230199 CC
|
81 Participants
|
67 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS2230199 CG
|
37 Participants
|
52 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS2230199 GG
|
6 Participants
|
8 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS3130783 AA
|
77 Participants
|
91 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS3130783 AG
|
44 Participants
|
32 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS3130783 GG
|
4 Participants
|
4 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS334353 GG
|
6 Participants
|
11 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS334353 GT
|
41 Participants
|
45 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS334353 TT
|
78 Participants
|
71 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS3812111 AA
|
31 Participants
|
16 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS3812111 AT
|
57 Participants
|
52 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS920915 CG
|
64 Participants
|
60 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS3812111 TT
|
36 Participants
|
54 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS429608 AA
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS429608 AG
|
19 Participants
|
19 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS429608 GG
|
103 Participants
|
103 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS4420638 AA
|
89 Participants
|
96 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS4420638 AG
|
35 Participants
|
31 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS4698775 GG
|
11 Participants
|
8 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS4698775 GT
|
53 Participants
|
71 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS920915 GG
|
28 Participants
|
34 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS4698775 TT
|
60 Participants
|
47 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS5749482 CC
|
4 Participants
|
1 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS5749482 CG
|
26 Participants
|
26 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS5749482 GG
|
95 Participants
|
100 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS6795735 CC
|
43 Participants
|
37 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS6795735 CT
|
53 Participants
|
63 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS6795735 TT
|
28 Participants
|
27 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS8017304 AA
|
57 Participants
|
65 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS8017304 AG
|
53 Participants
|
51 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS8017304 GG
|
15 Participants
|
11 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS8135665 CC
|
68 Participants
|
79 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS943080 CC
|
27 Participants
|
35 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS943080 CT
|
57 Participants
|
64 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS943080 TT
|
40 Participants
|
28 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS9542236 CC
|
26 Participants
|
26 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS9542236 CT
|
61 Participants
|
63 Participants
|
|
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
RS9542236 TT
|
38 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Month 12 and 24Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=6 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=6 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF
Month 12
|
3 Participants
|
2 Participants
|
|
Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF
Month 24
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Month 24Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint.
Treatment requirements will be determined by the individual patient disease activity as measured by OCT, BCVA, colour fundus photography and fluorescein angiography (FA). Analysis was not performed.
Outcome measures
| Measure |
Intensive Retinal Fluid Regimen
n=172 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
|
Relaxed Retinal Fluid Regimen
n=173 Participants
Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of ≥5 letters, new retinal haemorrhage, presence of IRF or SRF \>200 um on OCT.
|
|---|---|---|
|
The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.
|
10.6 Visits
Standard Deviation 8.34
|
7.6 Visits
Standard Deviation 8.09
|
Adverse Events
Intensive
Serious events: 58 serious events
Other events: 109 other events
Deaths: 7 deaths
Relaxed
Serious events: 58 serious events
Other events: 114 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Intensive
n=173 participants at risk
Intensive
|
Relaxed
n=174 participants at risk
Relaxed
|
|---|---|---|
|
Injury, poisoning and procedural complications
Foot fracture(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Head injury(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Hip fracture(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Humerus fracture(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Joint dislocation(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Joint injury(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Laceration(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Pelvic fracture(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Pulmonary contusion(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Rib fracture(Non-ocular)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Skull fracture(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Investigations
Blood sodium decreased(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Metabolism and nutrition disorders
Fluid overload(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Metabolism and nutrition disorders
Hyponatraemia(Non-ocular)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Myalgia(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
1.7%
3/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
3/173 • Up to 24 month
AE additional description
|
2.3%
4/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Convulsion
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Dizziness
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Presyncope
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Syncope
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Transient ischaemic attack
|
2.3%
4/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Psychiatric disorders
Confusional state
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Psychiatric disorders
Delirium
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Haematuria
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Renal disorder
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Renal impairment
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Urinary retention
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Surgical and medical procedures
Hospitalisation
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Arteriovenous fistula
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Hypertension
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Hypotension
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Orthostatic hypotension
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Blood and lymphatic system disorders
Anaemia(Non-ocular)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Acute myocardial infarction(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Arrhythmia(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Atrial fibrillation(Non-ocular)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
4.0%
7/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Bradycardia(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Cardiac failure congestive(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Cardiac failure(Non-ocular)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Cardiogenic shock(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Coronary artery disease(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Myocardial infarction(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Myocardial ischaemia(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Pericarditis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Tachycardia(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Ventricular tachycardia(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Congenital, familial and genetic disorders
Phimosis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Ear and labyrinth disorders
Meniere's disease(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Ear and labyrinth disorders
Vertigo positional(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Macular hole(Left eye)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Retinal artery occlusion(Right eye)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Retinal pigment epithelial tear(Left eye)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain upper(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Alcoholic pancreatitis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Barrett's oesophagus(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Dysphagia(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Gastric ulcer(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Gastrointestinal oedema(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Haematemesis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Intestinal perforation(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Pancreatitis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Peptic ulcer(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Vomiting(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
General disorders
Catheter site extravasation(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
General disorders
Chest pain(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
General disorders
Death(Non-ocular)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
General disorders
Disease progression(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Cholecystitis acute(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Cholecystitis chronic(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Cholelithiasis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Hepatic cirrhosis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Jaundice cholestatic(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Immune system disorders
Drug hypersensitivity(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Appendicitis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Arthritis infective(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Bacteraemia(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Bronchitis(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Cystitis()
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Cystitis(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Endophthalmitis(Right eye)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Escherichia bacteraemia(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Gastroenteritis viral(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Gastroenteritis(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Herpes zoster(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Influenza(Non-ocular)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Klebsiella infection(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Localised infection(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Lower respiratory tract infection(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.7%
3/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Pertussis(Left eye)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Pneumonia(Non-ocular)
|
5.8%
10/173 • Up to 24 month
AE additional description
|
2.9%
5/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Sepsis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Skin graft infection(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Urinary tract infection(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Urosepsis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Accidental overdose(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Cataract operation complication(Right eye)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Clavicle fracture(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Fall(Non-ocular)
|
2.3%
4/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Femoral neck fracture(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma(Non-ocular)
|
1.7%
3/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Cerebral haemorrhage(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Cerebrovascular accident(Non-ocular)
|
1.7%
3/173 • Up to 24 month
AE additional description
|
2.3%
4/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Convulsion(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Dementia Alzheimer's type(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Dizziness(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Neuralgia(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Presyncope(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Syncope(Non-ocular)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Transient ischaemic attack(Non-ocular)
|
2.3%
4/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Psychiatric disorders
Confusional state(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Psychiatric disorders
Delirium(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Haematuria(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Nephrolithiasis(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Renal disorder(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Myocardial infarction
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Myocardial ischaemia
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Ventricular tachycardia
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Macular hole
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Retinal artery occlusion
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Dysphagia
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Vomiting
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
General disorders
Catheter site extravasation
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
General disorders
Chest pain
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
General disorders
Death
|
1.2%
2/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
General disorders
Disease progression
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Appendicitis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Arthritis infective
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Bronchitis
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Cystitis
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Endophthalmitis
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Gastroenteritis
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Gastroenteritis viral
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Influenza
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Localised infection
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Lower respiratory tract infection
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.7%
3/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Pertussis
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Pneumonia
|
5.8%
10/173 • Up to 24 month
AE additional description
|
2.9%
5/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Sepsis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Skin graft infection
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Urosepsis
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
4/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Laceration
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Investigations
Blood sodium decreased
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Acute myocardial infarction
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/173 • Up to 24 month
AE additional description
|
4.0%
7/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Cardiac failure
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Cardiac failure congestive
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Renal failure acute(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Renal impairment(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Renal injury(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Renal and urinary disorders
Urinary retention(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Asthma(Non-ocular)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Skin and subcutaneous tissue disorders
Skin ulcer(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Surgical and medical procedures
Hospitalisation()
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Surgical and medical procedures
Hospitalisation(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Surgical and medical procedures
Percutaneous coronary intervention(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Arteriovenous fistula(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Blood pressure fluctuation(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Haemorrhage(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Hypertension(Non-ocular)
|
0.00%
0/173 • Up to 24 month
AE additional description
|
0.57%
1/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Hypotension(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
0.00%
0/174 • Up to 24 month
AE additional description
|
|
Vascular disorders
Orthostatic hypotension(Non-ocular)
|
0.58%
1/173 • Up to 24 month
AE additional description
|
1.1%
2/174 • Up to 24 month
AE additional description
|
Other adverse events
| Measure |
Intensive
n=173 participants at risk
Intensive
|
Relaxed
n=174 participants at risk
Relaxed
|
|---|---|---|
|
Eye disorders
Age-related macular degeneration
|
10.4%
18/173 • Up to 24 month
AE additional description
|
9.8%
17/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Cataract
|
2.3%
4/173 • Up to 24 month
AE additional description
|
7.5%
13/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Conjunctival haemorrhage
|
4.6%
8/173 • Up to 24 month
AE additional description
|
7.5%
13/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Dry eye
|
4.6%
8/173 • Up to 24 month
AE additional description
|
5.2%
9/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Eye pain
|
16.2%
28/173 • Up to 24 month
AE additional description
|
13.8%
24/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Eye pruritus
|
5.2%
9/173 • Up to 24 month
AE additional description
|
2.9%
5/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Foreign body sensation in eyes
|
4.6%
8/173 • Up to 24 month
AE additional description
|
6.3%
11/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Lacrimation increased
|
9.8%
17/173 • Up to 24 month
AE additional description
|
4.6%
8/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Retinal haemorrhage
|
4.0%
7/173 • Up to 24 month
AE additional description
|
6.9%
12/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Vision blurred
|
9.2%
16/173 • Up to 24 month
AE additional description
|
5.7%
10/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Visual acuity reduced
|
5.2%
9/173 • Up to 24 month
AE additional description
|
6.3%
11/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Vitreous detachment
|
6.4%
11/173 • Up to 24 month
AE additional description
|
6.3%
11/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Vitreous floaters
|
12.1%
21/173 • Up to 24 month
AE additional description
|
6.3%
11/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Nausea
|
4.6%
8/173 • Up to 24 month
AE additional description
|
5.7%
10/174 • Up to 24 month
AE additional description
|
|
General disorders
Disease progression
|
5.2%
9/173 • Up to 24 month
AE additional description
|
3.4%
6/174 • Up to 24 month
AE additional description
|
|
General disorders
Injection site pain
|
8.1%
14/173 • Up to 24 month
AE additional description
|
4.6%
8/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Influenza
|
15.0%
26/173 • Up to 24 month
AE additional description
|
9.2%
16/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Lower respiratory tract infection
|
5.8%
10/173 • Up to 24 month
AE additional description
|
6.3%
11/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
23/173 • Up to 24 month
AE additional description
|
16.7%
29/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
6.4%
11/173 • Up to 24 month
AE additional description
|
7.5%
13/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Fall
|
12.1%
21/173 • Up to 24 month
AE additional description
|
8.6%
15/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Dizziness
|
6.4%
11/173 • Up to 24 month
AE additional description
|
5.2%
9/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Headache
|
9.2%
16/173 • Up to 24 month
AE additional description
|
5.2%
9/174 • Up to 24 month
AE additional description
|
|
Psychiatric disorders
Depression
|
1.7%
3/173 • Up to 24 month
AE additional description
|
6.3%
11/174 • Up to 24 month
AE additional description
|
|
Surgical and medical procedures
Cataract operation
|
3.5%
6/173 • Up to 24 month
AE additional description
|
5.7%
10/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Age-related macular degeneration(Left eye)
|
4.6%
8/173 • Up to 24 month
AE additional description
|
8.0%
14/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Age-related macular degeneration(Right eye)
|
6.4%
11/173 • Up to 24 month
AE additional description
|
2.9%
5/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Cataract(Left eye)
|
1.2%
2/173 • Up to 24 month
AE additional description
|
5.2%
9/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Eye pain(Left eye)
|
6.9%
12/173 • Up to 24 month
AE additional description
|
6.3%
11/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Eye pain(Right eye)
|
6.4%
11/173 • Up to 24 month
AE additional description
|
7.5%
13/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Lacrimation increased(Right eye)
|
5.2%
9/173 • Up to 24 month
AE additional description
|
2.3%
4/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Retinal haemorrhage(Left eye)
|
3.5%
6/173 • Up to 24 month
AE additional description
|
5.2%
9/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Vision blurred(Right eye)
|
5.2%
9/173 • Up to 24 month
AE additional description
|
1.7%
3/174 • Up to 24 month
AE additional description
|
|
Eye disorders
Vitreous floaters(Left eye)
|
8.1%
14/173 • Up to 24 month
AE additional description
|
2.9%
5/174 • Up to 24 month
AE additional description
|
|
Gastrointestinal disorders
Nausea(Non-ocular)
|
4.6%
8/173 • Up to 24 month
AE additional description
|
5.7%
10/174 • Up to 24 month
AE additional description
|
|
General disorders
Injection site pain(Right eye)
|
5.2%
9/173 • Up to 24 month
AE additional description
|
2.3%
4/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Influenza(Non-ocular)
|
15.0%
26/173 • Up to 24 month
AE additional description
|
9.2%
16/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Lower respiratory tract infection(Non-ocular)
|
5.8%
10/173 • Up to 24 month
AE additional description
|
6.3%
11/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Nasopharyngitis(Non-ocular)
|
13.3%
23/173 • Up to 24 month
AE additional description
|
16.7%
29/174 • Up to 24 month
AE additional description
|
|
Infections and infestations
Urinary tract infection(Non-ocular)
|
6.4%
11/173 • Up to 24 month
AE additional description
|
7.5%
13/174 • Up to 24 month
AE additional description
|
|
Injury, poisoning and procedural complications
Fall(Non-ocular)
|
12.1%
21/173 • Up to 24 month
AE additional description
|
8.6%
15/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Dizziness(Non-ocular)
|
6.4%
11/173 • Up to 24 month
AE additional description
|
5.2%
9/174 • Up to 24 month
AE additional description
|
|
Nervous system disorders
Headache(Non-ocular)
|
8.7%
15/173 • Up to 24 month
AE additional description
|
4.6%
8/174 • Up to 24 month
AE additional description
|
|
Psychiatric disorders
Depression(Non-ocular)
|
1.7%
3/173 • Up to 24 month
AE additional description
|
6.3%
11/174 • Up to 24 month
AE additional description
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER