Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
Official Title
A Double-Masked, Randomized, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema
Acronym
VISTA DME
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Apr 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2011
Primary Completion Date
Jan 2013Actual
Completion Date
Nov 2014Actual
First Submitted Date
May 27, 2011
First Submission Date that Met QC Criteria
May 31, 2011
First Posted Date
Jun 1, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 28, 2014
Results First Submitted that Met QC Criteria
Apr 2, 2015
Results First Posted Date
Apr 20, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 11, 2014
Certification/Extension First Submitted that Passed QC Review
Feb 11, 2014
Certification/Extension First Posted Date
Mar 13, 2014Estimated
Last Update Submitted Date
Apr 25, 2016
Last Update Posted Date
May 30, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Name
Class
Bayer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.
Baseline and Week 52
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Baseline and Week 52
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The following is an abbreviated list of inclusion criteria:
Adults ≥ 18 years with type 1 or 2 diabetes mellitus
Decrease in vision determined to be primarily the result of DME in the study eye
BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion Criteria:
The following is an abbreviated list of exclusion criteria:
Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1
Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1
Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1
Active proliferative diabetic retinopathy (PDR) in the study eye
Uncontrolled diabetes mellitus
Only 1 functional eye even if that eye is otherwise eligible for the study
Matar K, Indurkar A, Yordi S, Cetin H, Reese JL, Srivastava SK, Ehlers JP. Expanding insights from the VISTA phase III trial: longitudinal comparative assessment of ellipsoid zone integrity and volumetric fluid dynamics. Sci Rep. 2025 Dec 5;15(1):43222. doi: 10.1038/s41598-025-27350-w.
Dhoot DS, Moini H, Reed K, Silva FQ, Berliner A, Du W, Sharma S. INCIDENCE OF NEW DIABETIC MACULAR EDEMA IN FELLOW EYES OF PATIENTS IN THE VISTA AND VIVID STUDIES. Retina. 2023 Feb 1;43(2):254-262. doi: 10.1097/IAE.0000000000003658. Epub 2022 Oct 17.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Of 687 participants who were screened for inclusion in the study, 466 were enrolled (started) and 461 received treatment.
Recruitment Details
Participants with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye could participate in the study.
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF
Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
Baseline and Week 52
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
Baseline and Week 52
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Baseline and Week 52
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.
Dhoot DS, Moini H, Reed K, Du W, Vitti R, Berliner AJ, Singh RP. Functional outcomes of sustained improvement on Diabetic Retinopathy Severity Scale with intravitreal aflibercept in the VISTA and VIVID trials. Eye (Lond). 2023 Jul;37(10):2020-2025. doi: 10.1038/s41433-022-02058-7. Epub 2022 Apr 19.
Wykoff CC, Shah C, Dhoot D, Coleman HR, Thompson D, Du W, Baker K, Vitti R, Berliner AJ, Metzig C, Saroj N. Longitudinal Retinal Perfusion Status in Eyes with Diabetic Macular Edema Receiving Intravitreal Aflibercept or Laser in VISTA Study. Ophthalmology. 2019 Aug;126(8):1171-1180. doi: 10.1016/j.ophtha.2019.03.040. Epub 2019 Apr 1.
Midena E, Gillies M, Katz TA, Metzig C, Lu C, Ogura Y. Impact of Baseline Central Retinal Thickness on Outcomes in the VIVID-DME and VISTA-DME Studies. J Ophthalmol. 2018 Mar 29;2018:3640135. doi: 10.1155/2018/3640135. eCollection 2018.
Staurenghi G, Feltgen N, Arnold JJ, Katz TA, Metzig C, Lu C, Holz FG; VIVID-DME and VISTA-DME study investigators. Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies. Br J Ophthalmol. 2018 Jul;102(7):954-958. doi: 10.1136/bjophthalmol-2017-310664. Epub 2017 Oct 19.
Wykoff CC, Marcus DM, Midena E, Korobelnik JF, Saroj N, Gibson A, Vitti R, Berliner AJ, Williams Liu Z, Zeitz O, Metzig C, Schmelter T, Heier JS. Intravitreal Aflibercept Injection in Eyes With Substantial Vision Loss After Laser Photocoagulation for Diabetic Macular Edema: Subanalysis of the VISTA and VIVID Randomized Clinical Trials. JAMA Ophthalmol. 2017 Feb 1;135(2):107-114. doi: 10.1001/jamaophthalmol.2016.4912.
Ziemssen F, Schlottman PG, Lim JI, Agostini H, Lang GE, Bandello F. Initiation of intravitreal aflibercept injection treatment in patients with diabetic macular edema: a review of VIVID-DME and VISTA-DME data. Int J Retina Vitreous. 2016 Jul 11;2:16. doi: 10.1186/s40942-016-0041-z. eCollection 2016.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
FG000156 subjectsrandomized
FG001156 subjectsrandomized
FG002154 subjectsrandomized
Participants Received Treatment
FG000154 subjectssafety analysis set (SAF)
FG001155 subjectssafety analysis set (SAF)
FG002152 subjectssafety analysis set (SAF)
Completed Week 52
FG000145 subjects
FG001146 subjects
FG002144 subjects
Completed Week 100
FG000133 subjects
FG001125 subjects
FG002127 subjects
COMPLETED
FG000133 subjectsCompleted Week 100
FG001125 subjectsCompleted Week 100
FG002127 subjectsCompleted Week 100
NOT COMPLETED
FG00023 subjects
FG00131 subjects
FG00227 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0014 subjects
FG0024 subjects
Death
FG0003 subjects
FG0017 subjects
FG0025 subjects
Withdrawal by Subject
FG0009 subjects
FG00111 subjects
FG00211 subjects
Lost to Follow-up
FG0002 subjects
FG0014 subjects
FG0025 subjects
Other
FG0004 subjects
FG0015 subjects
FG0022 subjects
Baseline population analyzed using the SAF
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Control
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000154
BG001155
BG002152
BG003461
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00061.7± 8.65
BG00162± 11.16
BG00263.1± 9.36
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00069
BG00168
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.
The Primary efficacy endpoint was analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).
Posted
Least Squares Mean
Standard Error
letters correctly read
Baseline and Week 52
ID
Title
Description
OG000
Control
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Units
Counts
Participants
OG000154
OG001154
OG002151
Title
Denominators
Categories
Title
Measurements
OG000.10± 1.03
OG00112.3± .76
OG00210.6± .69
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<.0001
Mean Difference (Net)
12.19
2-Sided
97.5
9.35
15.04
No
Superiority or Other
OG000
OG002
ANCOVA
<.0001
Secondary
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
All secondary efficacy endpoints were analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).
Posted
Number
percentage of participants
Baseline and Week 52
ID
Title
Description
OG000
Control
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Secondary
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Posted
Number
percentage of participants
Baseline and Week 52
ID
Title
Description
OG000
Control
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Units
Counts
Participants
Secondary
Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF
Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
Posted
Number
percentage of participants
Baseline and Week 52
ID
Title
Description
OG000
Control
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Secondary
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
Posted
Least Squares Mean
Standard Error
microns
Baseline and Week 52
ID
Title
Description
OG000
Control
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Posted
Least Squares Mean
Standard Error
scores on a scale
Baseline and Week 52
ID
Title
Description
OG000
Control
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Secondary
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.
Posted
Least Squares Mean
Standard Error
scores on a scale
Baseline and Week 52
ID
Title
Description
OG000
Control
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Time Frame
From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Control (Week 0 to Week 100)
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
67
154
91
154
EG001
IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 100)
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
67
155
90
155
EG002
IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 100)
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
56
152
76
152
EG003
Control (Week 0 to Week 148)
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
84
154
134
154
EG004
IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 148)
Participants received 2mg Intravitreal aflibercept injection(IAI) every 4 weeks.
85
155
137
155
EG005
IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 148)
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
75
152
136
152
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0019 affected155 at risk
EG0025 affected152 at risk
EG0032 affected154 at risk
EG00410 affected155 at risk
EG0056 affected152 at risk
Coagulopathy
Blood and lymphatic system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Haemorrhagic anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Nephrogenic anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Normochromic normocytic anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0012 affected155 at risk
EG0022 affected152 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0021 affected152 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0023 affected152 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0021 affected152 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0011 affected155 at risk
EG0021 affected152 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0004 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0005 affected154 at risk
EG0019 affected155 at risk
EG0025 affected152 at risk
EG003
Cor pulmonale chronic
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0014 affected155 at risk
EG0022 affected152 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0022 affected152 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0014 affected155 at risk
EG0025 affected152 at risk
EG003
Coronary ostial stenosis
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0015 affected155 at risk
EG0023 affected152 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Systolic dysfunction
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cataract
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cataract
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0001 affected154 at risk
EG0014 affected155 at risk
EG0020 affected152 at risk
EG003
Cataract subcapsular
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cataract subcapsular
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Corneal epithelium defect
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Diabetic retinal oedema
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Diabetic retinal oedema
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0002 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Hyphaema
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Intraocular pressure increased
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Iris neovascularisation
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Lens dislocation
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Macular ischaemia
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal aneurysm
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal artery occlusion
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Retinal artery occlusion
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0012 affected155 at risk
EG0021 affected152 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal ischaemia
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal ischaemia
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal neovascularisation
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal tear
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal vascular disorder
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0021 affected152 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0021 affected152 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0003 affected154 at risk
EG0012 affected155 at risk
EG0021 affected152 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0017 affected155 at risk
EG0022 affected152 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Vitreous opacities
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Diabetic gastroparesis
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0013 affected155 at risk
EG0021 affected152 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Internal hernia
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Mallory-Weiss syndrome
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Volvulus of small bowel
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Asthenia
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0022 affected152 at risk
EG003
Chest pain
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0011 affected155 at risk
EG0024 affected152 at risk
EG003
Death
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Device failure
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Device malfunction
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Generalised oedema
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Medical device complication
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Multi-organ failure
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Oedema peripheral
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Pyrexia
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Gallbladder cholesterolosis
Hepatobiliary disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0012 affected155 at risk
EG0022 affected152 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Breast cellulitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0021 affected152 at risk
EG003
Burn infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0004 affected154 at risk
EG0017 affected155 at risk
EG0028 affected152 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Diabetic foot infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Endocarditis bacterial
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Gangrene
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0012 affected155 at risk
EG0021 affected152 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0022 affected152 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Infected skin ulcer
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Localised infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0015 affected155 at risk
EG0022 affected152 at risk
EG003
Osteomyelitis acute
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Parotitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Perineal abscess
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0004 affected154 at risk
EG0014 affected155 at risk
EG0023 affected152 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Sepsis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0012 affected155 at risk
EG0020 affected152 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0012 affected155 at risk
EG0021 affected152 at risk
EG003
Wound sepsis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0021 affected152 at risk
EG003
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Arteriovenous fistula site haemorrhage
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Arteriovenous graft site haemorrhage
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Cataract operation complication
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cataract traumatic
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Clavical fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0013 affected155 at risk
EG0025 affected152 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0012 affected155 at risk
EG0020 affected152 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0012 affected155 at risk
EG0021 affected152 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Wound haemorrhage
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Heart rate increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Transaminases increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Troponin increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Visual acuity tests abnormal
Investigations
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0012 affected155 at risk
EG0022 affected152 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0013 affected155 at risk
EG0022 affected152 at risk
EG003
Diabetes with hyperosmolarity
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0012 affected155 at risk
EG0022 affected152 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0004 affected154 at risk
EG0013 affected155 at risk
EG0021 affected152 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0015 affected155 at risk
EG0020 affected152 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Ketosis
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0022 affected152 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Neuropathic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0012 affected155 at risk
EG0020 affected152 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0014 affected155 at risk
EG0020 affected152 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Tendonitits
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Bladder cancer stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0013 affected155 at risk
EG0020 affected152 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Chronic myelomonocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Diffuse large B-cell lymphoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0023 affected152 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0013 affected155 at risk
EG0020 affected152 at risk
EG003
Prostate cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Rectal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0022 affected152 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Autonomic nervous system imbalance
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Brain injury
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Brain stem stroke
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0012 affected155 at risk
EG0020 affected152 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0015 affected155 at risk
EG0025 affected152 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Coma
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Diabetic coma
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Hemianopia homonymous
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Hypertensive encephalopathy
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Ischaemic cerebral infarction
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Sedation
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Syncope
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0012 affected155 at risk
EG0020 affected152 at risk
EG003
Thalamic infarction
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0012 affected155 at risk
EG0021 affected152 at risk
EG003
Schizoaffective disorder
Psychiatric disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Bladder outlet obstruction
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Intercapillary glomerulosclerosis
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0021 affected152 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Nephropathy toxic
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Nephrosclerosis
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0004 affected154 at risk
EG0015 affected155 at risk
EG0021 affected152 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG0016 affected155 at risk
EG0026 affected152 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0014 affected155 at risk
EG0023 affected152 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Ureteric stenosis
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Labia enlarged
Reproductive system and breast disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Uterine mass
Reproductive system and breast disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0021 affected152 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0012 affected155 at risk
EG0020 affected152 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0012 affected155 at risk
EG0022 affected152 at risk
EG003
Hypertrophic scar
Skin and subcutaneous tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Arteriovenous fistula operation
Surgical and medical procedures
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Coronary artery bypass
Surgical and medical procedures
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Foot amputation
Surgical and medical procedures
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Haematoma
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0015 affected155 at risk
EG0021 affected152 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0012 affected155 at risk
EG0020 affected152 at risk
EG003
Hypertensive emergency
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Hypotension
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Malignant hypertension
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0011 affected155 at risk
EG0020 affected152 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Peripheral artery stenosis
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0020 affected152 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG0000 affected154 at risk
EG0010 affected155 at risk
EG0021 affected152 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Non-systematic Assessment
EG00012 affected154 at risk
EG00120 affected155 at risk
EG00212 affected152 at risk
EG00315 affected154 at risk
EG00427 affected155 at risk
EG00520 affected152 at risk
Anxiety
Psychiatric disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG00112 affected155 at risk
EG0024 affected152 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0009 affected154 at risk
EG0018 affected155 at risk
EG0028 affected152 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0006 affected154 at risk
EG0015 affected155 at risk
EG00210 affected152 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0008 affected154 at risk
EG00120 affected155 at risk
EG0026 affected152 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG00012 affected154 at risk
EG0017 affected155 at risk
EG0024 affected152 at risk
EG003
Blood glucose increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0006 affected154 at risk
EG0019 affected155 at risk
EG00211 affected152 at risk
EG003
Blood pressure increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG00010 affected154 at risk
EG0019 affected155 at risk
EG0027 affected152 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0012 affected155 at risk
EG0025 affected152 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG00011 affected154 at risk
EG00112 affected155 at risk
EG0024 affected152 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 16.1
Non-systematic Assessment
EG0006 affected154 at risk
EG00112 affected155 at risk
EG0029 affected152 at risk
EG003
Cataract
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00017 affected154 at risk
EG00115 affected155 at risk
EG00211 affected152 at risk
EG003
Cataract
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00016 affected154 at risk
EG00121 affected155 at risk
EG00213 affected152 at risk
EG003
Cataract cortical
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0006 affected154 at risk
EG0013 affected155 at risk
EG0026 affected152 at risk
EG003
Cataract cortical
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0008 affected154 at risk
EG0012 affected155 at risk
EG0027 affected152 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0002 affected154 at risk
EG0016 affected155 at risk
EG0022 affected152 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0016 affected155 at risk
EG0022 affected152 at risk
EG003
Cataract subcapsular
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0006 affected154 at risk
EG0014 affected155 at risk
EG0028 affected152 at risk
EG003
Cataract subcapsular
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0007 affected154 at risk
EG0016 affected155 at risk
EG0028 affected152 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG00110 affected155 at risk
EG00212 affected152 at risk
EG003
Chest pain
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0009 affected154 at risk
EG0013 affected155 at risk
EG0025 affected152 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00029 affected154 at risk
EG00130 affected155 at risk
EG00227 affected152 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00053 affected154 at risk
EG00163 affected155 at risk
EG00248 affected152 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0009 affected154 at risk
EG00111 affected155 at risk
EG0025 affected152 at risk
EG003
Corneal abrasion
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0006 affected154 at risk
EG0014 affected155 at risk
EG0026 affected152 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG00013 affected154 at risk
EG00118 affected155 at risk
EG00217 affected152 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG0017 affected155 at risk
EG0024 affected152 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG00020 affected154 at risk
EG00113 affected155 at risk
EG00219 affected152 at risk
EG003
Diabetic retinal oedema
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00019 affected154 at risk
EG00122 affected155 at risk
EG00218 affected152 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00011 affected154 at risk
EG0018 affected155 at risk
EG00214 affected152 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG00013 affected154 at risk
EG00114 affected155 at risk
EG0026 affected152 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0008 affected154 at risk
EG0017 affected155 at risk
EG0029 affected152 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0015 affected155 at risk
EG0023 affected152 at risk
EG003
Dry eye
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG00112 affected155 at risk
EG0027 affected152 at risk
EG003
Dry eye
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00010 affected154 at risk
EG00114 affected155 at risk
EG0027 affected152 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0006 affected154 at risk
EG00112 affected155 at risk
EG00211 affected152 at risk
EG003
Ear infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0004 affected154 at risk
EG0013 affected155 at risk
EG0026 affected152 at risk
EG003
Eye irritation
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00012 affected154 at risk
EG00115 affected155 at risk
EG00211 affected152 at risk
EG003
Eye irritation
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG0016 affected155 at risk
EG0027 affected152 at risk
EG003
Eye pain
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00020 affected154 at risk
EG00123 affected155 at risk
EG00221 affected152 at risk
EG003
Eye pain
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG00111 affected155 at risk
EG0029 affected152 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0008 affected154 at risk
EG0017 affected155 at risk
EG00212 affected152 at risk
EG003
Fatigue
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0004 affected154 at risk
EG0018 affected155 at risk
EG0023 affected152 at risk
EG003
Foreign body sensation in eyes
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0008 affected154 at risk
EG0018 affected155 at risk
EG0025 affected152 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0012 affected155 at risk
EG0026 affected152 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0009 affected154 at risk
EG00110 affected155 at risk
EG0024 affected152 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG0017 affected155 at risk
EG00213 affected152 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG00019 affected154 at risk
EG00118 affected155 at risk
EG0027 affected152 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG00010 affected154 at risk
EG0015 affected155 at risk
EG0023 affected152 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0009 affected154 at risk
EG0019 affected155 at risk
EG0026 affected152 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.1
Non-systematic Assessment
EG00049 affected154 at risk
EG00141 affected155 at risk
EG00242 affected152 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0018 affected155 at risk
EG0025 affected152 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG0014 affected155 at risk
EG0025 affected152 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0009 affected154 at risk
EG0017 affected155 at risk
EG00216 affected152 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0002 affected154 at risk
EG00112 affected155 at risk
EG00210 affected152 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0003 affected154 at risk
EG0014 affected155 at risk
EG0027 affected152 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0006 affected154 at risk
EG0017 affected155 at risk
EG0026 affected152 at risk
EG003
Localised infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0005 affected154 at risk
EG00110 affected155 at risk
EG0025 affected152 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00015 affected154 at risk
EG00111 affected155 at risk
EG00215 affected152 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00012 affected154 at risk
EG00111 affected155 at risk
EG00216 affected152 at risk
EG003
Macular oedema
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0014 affected155 at risk
EG0026 affected152 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0008 affected154 at risk
EG0015 affected155 at risk
EG0022 affected152 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG00017 affected154 at risk
EG00117 affected155 at risk
EG00219 affected152 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG00015 affected154 at risk
EG00119 affected155 at risk
EG00211 affected152 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 16.1
Non-systematic Assessment
EG0005 affected154 at risk
EG0015 affected155 at risk
EG0027 affected152 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00012 affected154 at risk
EG0016 affected155 at risk
EG0026 affected152 at risk
EG003
Oedema peripheral
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0008 affected154 at risk
EG00115 affected155 at risk
EG00215 affected152 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG0017 affected155 at risk
EG0025 affected152 at risk
EG003
Pain in extremity
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00010 affected154 at risk
EG0018 affected155 at risk
EG0025 affected152 at risk
EG003
Photopsia
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0007 affected154 at risk
EG0012 affected155 at risk
EG0021 affected152 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG0018 affected155 at risk
EG0027 affected152 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00010 affected154 at risk
EG0015 affected155 at risk
EG0025 affected152 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00012 affected154 at risk
EG0017 affected155 at risk
EG0028 affected152 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 16.1
Non-systematic Assessment
EG0001 affected154 at risk
EG0018 affected155 at risk
EG0022 affected152 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0001 affected154 at risk
EG0015 affected155 at risk
EG0027 affected152 at risk
EG003
Pyrexia
General disorders
MedDRA 16.1
Non-systematic Assessment
EG0002 affected154 at risk
EG0017 affected155 at risk
EG0026 affected152 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG00011 affected154 at risk
EG00110 affected155 at risk
EG0029 affected152 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA 16.1
Non-systematic Assessment
EG0004 affected154 at risk
EG0019 affected155 at risk
EG0028 affected152 at risk
EG003
Retinal exudates
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00013 affected154 at risk
EG00112 affected155 at risk
EG0024 affected152 at risk
EG003
Retinal exudates
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00011 affected154 at risk
EG00112 affected155 at risk
EG0026 affected152 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00015 affected154 at risk
EG00110 affected155 at risk
EG0025 affected152 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00010 affected154 at risk
EG00111 affected155 at risk
EG0025 affected152 at risk
EG003
Retinal neovascularisation
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00010 affected154 at risk
EG00110 affected155 at risk
EG0024 affected152 at risk
EG003
Retinal neovascularisation
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00012 affected154 at risk
EG0013 affected155 at risk
EG0023 affected152 at risk
EG003
Retinal pigment epitheliopathy
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0003 affected154 at risk
EG0015 affected155 at risk
EG0028 affected152 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 16.1
Non-systematic Assessment
EG0008 affected154 at risk
EG0016 affected155 at risk
EG0029 affected152 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG00012 affected154 at risk
EG00113 affected155 at risk
EG00212 affected152 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0006 affected154 at risk
EG0019 affected155 at risk
EG0025 affected152 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG00013 affected154 at risk
EG00111 affected155 at risk
EG00215 affected152 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.1
Non-systematic Assessment
EG00014 affected154 at risk
EG00117 affected155 at risk
EG00226 affected152 at risk
EG003
Urine protein/ creatinine ratio increased
Investigations
MedDRA 16.1
Non-systematic Assessment
EG0008 affected154 at risk
EG0015 affected155 at risk
EG0022 affected152 at risk
EG003
Vision blurred
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00010 affected154 at risk
EG00111 affected155 at risk
EG0026 affected152 at risk
EG003
Vision blurred
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0005 affected154 at risk
EG0018 affected155 at risk
EG0025 affected152 at risk
EG003
Visual Impairment
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG0007 affected154 at risk
EG0011 affected155 at risk
EG0023 affected152 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG0006 affected154 at risk
EG0014 affected155 at risk
EG00210 affected152 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00011 affected154 at risk
EG0017 affected155 at risk
EG00210 affected152 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG0016 affected155 at risk
EG0025 affected152 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00016 affected154 at risk
EG00115 affected155 at risk
EG00218 affected152 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00015 affected154 at risk
EG00114 affected155 at risk
EG00222 affected152 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00010 affected154 at risk
EG00111 affected155 at risk
EG00210 affected152 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00014 affected154 at risk
EG00121 affected155 at risk
EG00217 affected152 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
Study eye
EG00012 affected154 at risk
EG0019 affected155 at risk
EG0022 affected152 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 16.1
Non-systematic Assessment
EG00011 affected154 at risk
EG0018 affected155 at risk
EG0025 affected152 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.1
Non-systematic Assessment
EG0007 affected154 at risk
EG00114 affected155 at risk
EG0023 affected152 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not less than 45 days prior to submission of any (M)anuscript, (I)nstitution shall, or cause PI to, provide (S)ponsor a copy of (M). (I) to consider comments submitted by (S), & to delete confidential information upon (S) request. At (S)'s request, (I) to delay publication for an additional 60 days to allow filing of patent applications. (I) & PI agree to delay publication, prior to (M) summarizing data from all sites, unless no (M) is published prior to first anniversary of final study report.