Treatment for CI-DME in Eyes With Very Good VA Study | NCT01909791

ID	Type	Description
EY14231	Other Grant/Funding Number	National Eye Institute
EY23207	Other Grant/Funding Number	National Eye Institute
EY18817	Other Grant/Funding Number	National Eye Institute

Name	Class
Regeneron Pharmaceuticals	INDUSTRY
National Eye Institute (NEI)	NIH
National Institutes of Health (NIH)	NIH

Description Module

Brief Summary

Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse) were eligible. Eyes that have central-involved DME with "good" visual acuity (20/25 or better) have not been addressed systematically by recent studies for treatment of DME. Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS) suggest that a substantial percentage of eyes with central-involved DME may retain good vision. The investigators do not know definitively whether eyes with central-involved DME and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept) therapy initially, or focal/grid laser treatment or observation initially followed by anti-VEGF only if vision worsens.

The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt anti-VEGF.

Secondary objectives include:

Comparing other visual acuity outcomes between treatment groups, such as the percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity
For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment
Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT central subfield (CSF) thickness, adjusted for baseline mean thickness
Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between treatment groups
Comparing safety outcomes between treatment groups
Comparing associated treatment and follow-up exam costs between treatment groups

Label	Type	Description	Intervention Names
Prompt Laser + Deferred Aflibercept	Experimental	Focal/grid laser followed by intravitreal aflibercept if vision worsens	Procedure: Prompt Laser Drug: Deferred aflibercept
Observation + Deferred Aflibercept	Active Comparator	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)	Procedure: Deferred laser Drug: Deferred aflibercept
Prompt Aflibercept	Experimental	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)	Drug: Prompt aflibercept Procedure: Deferred laser

Name	Type	Description	Arm Group Labels	Other Names
Prompt Laser	Procedure	Focal/grid laser performed at baseline and as needed during follow-up	Prompt Laser + Deferred Aflibercept

Measure	Description	Time Frame
Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).	2 years

Measure	Description	Time Frame
Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years
Diagnosis of diabetes mellitus (type 1 or type 2)

Any one of the following will be considered to be sufficient evidence that diabetes is present:
1. Current regular use of insulin for the treatment of diabetes
2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
3. Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization (WHO) criteria.
Able and willing to provide informed consent.

Meets all of the following ocular criteria in at least the one eye:

Best corrected E-ETDRS visual acuity letter score ≥ 79 (approximate Snellen equivalent 20/25 or better) at two consecutive visits within 1 to 28 days.
On clinical exam, definite retinal thickening due to DME involving the center of the macula.
Diabetic macular edema confirmed on OCT (equivalent to CSF thickness on OCT ≥250 microns on Zeiss Stratus or gender-specific spectral domain OCT equivalent) at two consecutive visits within 1 to 28 days.

(a) Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality.
The investigator is comfortable with the eye being randomized to any of the three treatment groups (observation, laser, or anti-VEGF initially).

(a) If focal/grid photocoagulation is contraindicated because all leaking microaneurysms are too close to the fovea or the investigator believes the DME that is present will not benefit from focal/grid photocoagulation, the eye should not be enrolled.
Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.

Exclusion Criteria:

History of chronic renal failure requiring dialysis or kidney transplant.
A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.
Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.

(a) Note: study participants cannot receive another investigational drug while participating in the study.
Known allergy to any component of the study drug.
Blood pressure >180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.

These drugs should not be used during the study.
For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 24 months.

(a) Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
Individual is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 24 months of the study.

Individual has any of the following ocular characteristics:

Macular edema is considered to be due to a cause other than DME.

a) An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are contributing to the macular edema.
An ocular condition is present such that, in the opinion of the investigator, any visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
An ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
Cataract is present that, in the opinion of the investigator, may alter visual acuity during the course of the study.
Any history of prior laser or other surgical, intravitreal, or peribulbar treatment for DME (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, or anti-VEGF).
History of topical steroid or nonsteroidal anti-inflammatory drugs (NSAID) treatment within 30 days prior to randomization.
History of intravitreal or peribulbar corticosteroid within 4 months prior to randomization for an ocular condition other than DME.
Any history of or anticipated need for intravitreal anti-VEGF within the next 6 months for an ocular condition other than DME (e.g. choroidal neovascularization, central retinal vein occlusion, PDR).
History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
Any history of vitrectomy.
History of major ocular surgery (cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
History of YAG capsulotomy performed within 2 months prior to randomization.
Aphakia.
Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.

Name	Affiliation	Role
Carl Baker, MD	Paducah Retina Center	Study Chair
Adam Glassman, MS	Jaeb Center for Health Research	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Retina and Vitreous Consultants		Phoenix	Arizona	85021	United States
University of Arizona Medical Center/Department of Ophthalmology

PubMed Identifier	Type	Citation	Retractions
32077907	Background	Glassman AR, Baker CW, Beaulieu WT, Bressler NM, Punjabi OS, Stockdale CR, Wykoff CC, Jampol LM, Sun JK; DRCR Retina Network. Assessment of the DRCR Retina Network Approach to Management With Initial Observation for Eyes With Center-Involved Diabetic Macular Edema and Good Visual Acuity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2020 Apr 1;138(4):341-349. doi: 10.1001/jamaophthalmol.2019.6035.
31037289

ID	Title	Description
FG000	Initiation With Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 18, 2014	Sep 11, 2019

Arm/Group Information

ID	Title	Description
BG000	Initiation With Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
BG001	Initiation With Laser Photocoagulation	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
BG002	Initiation With Observation	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Inter-Quartile Range

years

Participants

Units	Counts
Participants	BG000226 BG001240 BG002236 BG003

Title

Denominators

Categories

Title	Measurements
	OG00033 OG00136 OG00239

Secondary

Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline

Posted

Count of Units

Eyes

1 year

Eyes

ID	Title	Description
OG000	Initiation With Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initiation With Laser Photocoagulation	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Initiation With Observation

Secondary

Change in E-ETDRS Visual Acuity Letter Score From Baseline

Posted

Mean

Standard Deviation

units on a scale

1 year

Eyes

ID	Title	Description
OG000	Initiation With Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initiation With Laser Photocoagulation	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Initiation With Observation

Secondary

Change in E-ETDRS Visual Acuity Letter Score From Baseline Over 2 Years (Area Under the Curve)

Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800). The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up.

Best-corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the early treatment diabetic retinopathy study method . Best value on the scale 100, worst 0.

Posted

Mean

Standard Deviation

units on a scale

2 year

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Secondary

Change in OCT Central Subfield Thickness From Baseline

Posted

Mean

Standard Deviation

microns

2 years

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Secondary

Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening

Logarithmic transformation of optical coherence tomography central subfield thickness (CST) is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.

Posted

Count of Units

Eyes

1 year

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation

Secondary

Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease

Center-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men.

Posted

Count of Units

Eyes

1 year

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation

Secondary

Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant

Posted

Mean

Standard Deviation

Injections

1 year

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Secondary

Number of Eyes With ≥ 2-step Worsening of Diabetic Retinopathy

Includes eyes with baseline severity level of 75 (high-risk proliferative diabetic retinopathy) or less based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale.

Posted

Count of Units

Eyes

2 years

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Secondary

For Eyes Randomized to Initial Laser Photocoagulation and Initial Observation Groups, the Percentage Receiving Aflibercept Treatment

Posted

Count of Units

Eyes

2 years

Eyes

ID	Title	Description
OG000	Initiation With Laser Photocoagulation	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG001	Initiation With Observation	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Units	Counts
Participants

Secondary

Number of Eyes With at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline

Posted

Count of Units

Eyes

2 years

Eyes

ID	Title	Description
OG000	Initiation With Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initiation With Laser Photocoagulation	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Initiation With Observation

Secondary

Change in E-ETDRS Visual Acuity Letter Score From Baseline

Posted

Mean

Standard Deviation

units on a scale

2 years

Eyes

ID	Title	Description
OG000	Initiation With Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initiation With Laser Photocoagulation	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Initiation With Observation

Secondary

Change in OCT Central Subfield Thickness From Baseline

Measured using spectral-domain optical coherence tomography (OCT).

Posted

Mean

Standard Deviation

microns

1 year

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Secondary

Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening

Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.

Posted

Count of Units

Eyes

2 years

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation

Secondary

Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease

Posted

Count of Units

Eyes

2 years

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation

Secondary

Cumulative Number of Focal/Grid Photocoagulation Sessions Performed Per Participant

The initial laser session was completed for all eyes in the initial laser group.

Posted

Mean

Standard Deviation

Focal/grid photocoagulation session

2 years

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Secondary

Number of Eyes With ≥ 2-step Improvement of Diabetic Retinopathy

Includes eyes with baseline severity level of 35 (mild non-proliferative diabetic retinopathy) or greater based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale. Excludes eyes with severity level 60 at baseline since improvement is not possible in these eyes.

Posted

Count of Units

Eyes

2 years

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation

Secondary

Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant

Posted

Mean

Standard Deviation

Injections

2 years

Eyes

ID	Title	Description
OG000	Initial Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
OG001	Initial Laser With Deferred Aflibercept if Needed	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
OG002	Observation	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

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	Initiation With Laser Photocoagulation	Focal/grid laser followed by intravitreal aflibercept if vision worsens Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria	10	226	64	240	194	240
EG001	Initiation With Observation	No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria	9	240	77	236	197	236
EG002	Initiation With Aflibercept	Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met	5	236	69	226	185	226

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Lymphoma	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Plasma cell myeloma	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Angina pectoris	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Arrhythmia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Bicuspid aortic valve	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Bradycardia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Cardiac arrest	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Cardiac failure	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events4 affected240 at risk EG0015 events5 affected236 at risk EG0025 events5 affected226 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Coronary artery disease	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0013 events3 affected236 at risk EG0025 events5 affected226 at risk
Diabetes mellitus inadequate control	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events2 affected236 at risk EG0022 events2 affected226 at risk
Diabetic coma	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Diabetic ketoacidosis	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Hyperglycaemia	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Hypoglycaemia	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Thyroid cancer	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Cataract traumatic	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Vitreous haemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Appendicitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Ascites	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Gastroenteritis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Chest discomfort	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Chest pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0017 events6 affected236 at risk EG0023 events3 affected226 at risk
Death	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0012 events2 affected236 at risk EG0023 events3 affected226 at risk
Fatigue	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Flank pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hernia	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Multi-organ failure	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Oedema peripheral	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events3 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Peripheral swelling	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Liver abscess	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events1 affected236 at risk EG0020 events0 affected226 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hypersensitivity	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Abscess	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Bronchopneumonia	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Influenza	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Localised infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Sepsis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Staphylococcal infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Blood creatinine abnormal	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Blood electrolytes decreased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Blood glucose decreased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Blood glucose increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Blood potassium increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Troponin increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0023 events3 affected226 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hip fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Lower limb fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Multiple fractures	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Osteomyelitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Rib fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Aphasia	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Concussion	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Convulsion	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Seizure	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Syncope	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events1 affected236 at risk EG0020 events0 affected226 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Cardiorenal syndrome	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Cystitis	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
End stage renal disease	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Kidney infection	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Nephropathy	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Pyelonephritis	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Renal failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0023 events3 affected226 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Renal impairment	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Urinary tract infection	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Breast cancer	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Lung neoplasm malignant	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events1 affected226 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0013 events3 affected236 at risk EG0024 events4 affected226 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Cellulitis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0027 events6 affected226 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Gangrene	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Herpes zoster	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Abdominal hernia repair	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Cardiac operation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Carpal tunnel decompression	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Gastric banding	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Gastric bypass	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hysterectomy	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0023 events3 affected226 at risk
Knee operation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0023 events3 affected226 at risk
Leg amputation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Stent placement	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Toe amputation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Vascular graft	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Aortic stenosis	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Carotid artery disease	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Cerebral haemorrhage	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Cerebrovascular accident	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0013 events3 affected236 at risk EG0023 events3 affected226 at risk
Embolism	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Haematoma	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Haemorrhagic stroke	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Ischaemic stroke	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Poor peripheral circulation	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Transient ischaemic attack	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected240 at risk EG0019 events9 affected236 at risk EG0024 events4 affected226 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Lymphoedema	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Angina pectoris	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Arrhythmia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0023 events3 affected226 at risk
Atrial flutter	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0023 events3 affected226 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Bradycardia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Cardiac arrest	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Cardiac failure	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events5 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Coronary artery disease	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0014 events4 affected236 at risk EG0021 events1 affected226 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Long QT syndrome	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Palpitations	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Tachycardia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0023 events3 affected226 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Deafness	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Ear infection	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0015 events5 affected236 at risk EG0024 events4 affected226 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Mastoiditis	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Otitis externa	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Diabetes mellitus	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00011 events9 affected240 at risk EG0018 events8 affected236 at risk EG0025 events4 affected226 at risk
Diabetes mellitus inadequate control	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00010 events9 affected240 at risk EG0018 events7 affected236 at risk EG0027 events7 affected226 at risk
Diabetic ketoacidosis	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Goitre	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Hyperglycaemia	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Hypoglycaemia	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0026 events4 affected226 at risk
Hypothyroidism	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0016 events6 affected236 at risk EG0022 events2 affected226 at risk
Pituitary tumour benign	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Thyroid neoplasm	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0023 events3 affected226 at risk
Age-related macular degeneration	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Altered visual depth perception	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Amaurosis fugax	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Angle closure glaucoma	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Asthenopia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Blepharitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected240 at risk EG0013 events3 affected236 at risk EG0021 events1 affected226 at risk
Blepharospasm	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Borderline glaucoma	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Cataract	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00014 events14 affected240 at risk EG00115 events14 affected236 at risk EG00217 events17 affected226 at risk
Cataract cortical	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected240 at risk EG0016 events6 affected236 at risk EG00211 events11 affected226 at risk
Cataract nuclear	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0011 events1 affected236 at risk EG0028 events8 affected226 at risk
Cataract subcapsular	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0016 events4 affected236 at risk EG00213 events11 affected226 at risk
Chalazion	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Choroidal neovascularisation	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00011 events8 affected240 at risk EG00113 events9 affected236 at risk EG00223 events17 affected226 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Conjunctivitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Conjunctivitis allergic	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Conjunctivitis viral	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Corneal abrasion	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0013 events2 affected236 at risk EG0024 events3 affected226 at risk
Corneal defect	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Corneal disorder	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Corneal dystrophy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Corneal erosion	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Corneal oedema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Corneal opacity	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Corneal pigmentation	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Corneal scar	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Cystoid macular oedema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Diabetic retinal oedema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected240 at risk EG0017 events7 affected236 at risk EG0022 events2 affected226 at risk
Diabetic retinopathy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events6 affected240 at risk EG0012 events2 affected236 at risk EG0025 events5 affected226 at risk
Diplopia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events8 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Dry eye	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00012 events11 affected240 at risk EG00110 events8 affected236 at risk EG00218 events17 affected226 at risk
Eye discharge	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Eye irritation	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected240 at risk EG0017 events7 affected236 at risk EG00213 events12 affected226 at risk
Eye pain	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events5 affected240 at risk EG00114 events11 affected236 at risk EG00219 events16 affected226 at risk
Eye pruritus	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00010 events9 affected240 at risk EG0013 events3 affected236 at risk EG0026 events6 affected226 at risk
Eye swelling	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Eyelid margin crusting	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Eyelid oedema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Eyelid pain	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Eyelid ptosis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Foreign body in eye	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Glare	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hordeolum	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0012 events2 affected236 at risk EG0022 events1 affected226 at risk
Hyalosis asteroid	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hyphaema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Iris adhesions	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Iris neovascularisation	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Iritis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Keratitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Keratopathy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Lacrimation increased	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0009 events9 affected240 at risk EG00110 events8 affected236 at risk EG0028 events8 affected226 at risk
Macular degeneration	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Macular fibrosis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00010 events10 affected240 at risk EG0011 events1 affected236 at risk EG0027 events6 affected226 at risk
Macular ischaemia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Macular oedema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Meibomian gland dysfunction	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Metamorphopsia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0012 events2 affected236 at risk EG0024 events3 affected226 at risk
Ocular discomfort	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0014 events3 affected236 at risk EG0027 events7 affected226 at risk
Ocular hyperaemia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0026 events6 affected226 at risk
Ocular hypertension	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Ophthalmic herpes simplex	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Optic atrophy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Optic nerve cupping	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Photophobia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0018 events7 affected236 at risk EG0028 events8 affected226 at risk
Photopsia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0014 events4 affected236 at risk EG0027 events7 affected226 at risk
Posterior capsule opacification	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Punctate keratitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0013 events2 affected236 at risk EG0024 events4 affected226 at risk
Retinal aneurysm	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0015 events5 affected236 at risk EG0023 events3 affected226 at risk
Retinal artery embolism	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Retinal detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Retinal exudates	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events5 affected240 at risk EG00112 events12 affected236 at risk EG0027 events7 affected226 at risk
Retinal haemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG00111 events10 affected236 at risk EG0024 events4 affected226 at risk
Retinal ischaemia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Retinal neovascularisation	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0013 events3 affected236 at risk EG0023 events2 affected226 at risk
Retinal oedema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Retinal pigment epitheliopathy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Retinal tear	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Retinal vein occlusion	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Retinopathy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Retinopathy hypertensive	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Subretinal fibrosis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Ulcerative keratitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Vision blurred	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00039 events31 affected240 at risk EG00143 events34 affected236 at risk EG00246 events40 affected226 at risk
Visual acuity reduced	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00016 events15 affected240 at risk EG00116 events16 affected236 at risk EG0026 events6 affected226 at risk
Visual field defect	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Visual impairment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00012 events11 affected240 at risk EG00113 events11 affected236 at risk EG00211 events9 affected226 at risk
Vitreous adhesions	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Vitreous detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0014 events4 affected236 at risk EG00212 events12 affected226 at risk
Vitreous disorder	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Vitreous floaters	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00016 events16 affected240 at risk EG00122 events21 affected236 at risk EG00234 events27 affected226 at risk
Vitreous haemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events6 affected240 at risk EG0015 events5 affected236 at risk EG00211 events8 affected226 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0021 events1 affected226 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Appendicitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Colon adenoma	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Colon cancer	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Constipation	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0014 events3 affected236 at risk EG0021 events1 affected226 at risk
Dental caries	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected240 at risk EG0016 events6 affected236 at risk EG0029 events8 affected226 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0022 events2 affected226 at risk
Gastroenteritis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Gastroenteritis viral	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0016 events6 affected236 at risk EG0027 events7 affected226 at risk
Gingival pain	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0023 events3 affected226 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00012 events11 affected240 at risk EG0019 events8 affected236 at risk EG0028 events7 affected226 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Salivary gland disorder	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Tooth abscess	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0024 events4 affected226 at risk
Tooth fracture	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0010 events0 affected236 at risk EG0023 events3 affected226 at risk
Tooth infection	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0012 events2 affected236 at risk EG0025 events4 affected226 at risk
Tooth loss	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Toothache	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected240 at risk EG0010 events0 affected236 at risk EG0027 events6 affected226 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected240 at risk EG0014 events4 affected236 at risk EG0028 events7 affected226 at risk
Chest discomfort	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Chest pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0017 events7 affected236 at risk EG0024 events3 affected226 at risk
Chills	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Cyst	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Fatigue	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0014 events4 affected236 at risk EG0025 events5 affected226 at risk
Flank pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Hernia	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Injection site discomfort	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Injection site irritation	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Lethargy	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Local swelling	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events1 affected236 at risk EG0020 events0 affected226 at risk
Necrosis	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Oedema peripheral	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00010 events8 affected240 at risk EG0018 events8 affected236 at risk EG0023 events3 affected226 at risk
Pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0012 events2 affected236 at risk EG0025 events4 affected226 at risk
Peripheral swelling	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0022 events2 affected226 at risk
Pyrexia	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0026 events6 affected226 at risk
Swelling	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0013 events3 affected236 at risk EG0024 events4 affected226 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Jaundice	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hypersensitivity	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0022 events2 affected226 at risk
Seasonal allergy	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events7 affected240 at risk EG0012 events2 affected236 at risk EG0026 events6 affected226 at risk
Systemic lupus erythematosus	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Urticaria	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Abscess	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Bronchopneumonia	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Candida infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Diverticulitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Escherichia infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Fungal infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Fungal skin infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Helicobacter infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0012 events2 affected236 at risk EG0022 events2 affected226 at risk
Influenza	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events7 affected240 at risk EG00110 events9 affected236 at risk EG00211 events10 affected226 at risk
Localised infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0012 events2 affected236 at risk EG00210 events8 affected226 at risk
Onychomycosis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0013 events3 affected236 at risk EG0021 events1 affected226 at risk
Oral herpes	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Respiratory tract infection fungal	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Sepsis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Staphylococcal infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0024 events3 affected226 at risk
Streptococcal infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0025 events5 affected226 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Chemical injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0018 events5 affected236 at risk EG0024 events4 affected226 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0024 events4 affected226 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0024 events3 affected226 at risk
Biopsy skin	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Blood creatine increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Blood creatinine abnormal	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Blood glucose decreased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Blood glucose increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Blood lactic acid increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Blood potassium increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Blood testosterone decreased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Carotid bruit	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Echocardiogram abnormal	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Free prostate-specific antigen increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Heart rate irregular	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Intraocular pressure increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0023 events3 affected226 at risk
Laboratory test abnormal	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0019 events2 affected236 at risk EG0023 events2 affected226 at risk
Low density lipoprotein increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Protein urine present	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Abnormal weight gain	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0023 events3 affected226 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events4 affected240 at risk EG0015 events5 affected236 at risk EG0027 events7 affected226 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0023 events3 affected226 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0014 events4 affected236 at risk EG0020 events0 affected226 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0012 events2 affected236 at risk EG0023 events3 affected226 at risk
Obesity	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0021 events1 affected226 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0018 events8 affected236 at risk EG0023 events3 affected226 at risk
Ankle fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00011 events11 affected240 at risk EG00111 events10 affected236 at risk EG0028 events7 affected226 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events5 affected240 at risk EG0015 events5 affected236 at risk EG0023 events3 affected226 at risk
Arthritis bacterial	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00014 events12 affected240 at risk EG0018 events8 affected236 at risk EG00210 events9 affected226 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Foot fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Gout	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0012 events2 affected236 at risk EG0022 events2 affected226 at risk
Hand fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Joint dislocation	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Ligament sprain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Lipoma	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Meniscus injury	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Multiple fractures	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0022 events2 affected226 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Muscle strain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events5 affected240 at risk EG0016 events5 affected236 at risk EG0023 events3 affected226 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0013 events3 affected236 at risk EG0024 events3 affected226 at risk
Myokymia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Osteomyelitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0023 events2 affected226 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected240 at risk EG00114 events11 affected236 at risk EG00210 events10 affected226 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Rib fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Stiff person syndrome	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0028 events4 affected226 at risk
Wrist fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0014 events4 affected236 at risk EG0020 events0 affected226 at risk
Apraxia	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Autonomic neuropathy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Balance disorder	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Benign intracranial hypertension	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Burning sensation	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Concussion	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0017 events7 affected236 at risk EG0020 events0 affected226 at risk
Dizziness	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0018 events7 affected236 at risk EG0028 events7 affected226 at risk
Epilepsy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Facial paralysis	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Head discomfort	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events7 affected240 at risk EG00116 events14 affected236 at risk EG00217 events15 affected226 at risk
Hemiplegia	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Lumbar spinal stenosis	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Memory impairment	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Migraine	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events4 affected240 at risk EG0011 events1 affected236 at risk EG0025 events5 affected226 at risk
Migraine with aura	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Myasthenia gravis	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Nerve compression	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0013 events3 affected236 at risk EG0021 events1 affected226 at risk
Nerve injury	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Paraesthesia	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Presyncope	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Restless legs syndrome	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Sciatica	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Seizure	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Somnolence	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Syncope	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Tension headache	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Tremor	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Ulnar nerve injury	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Vertigo	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events7 affected240 at risk EG0017 events6 affected236 at risk EG0021 events1 affected226 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Anxiety	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events3 affected240 at risk EG0016 events6 affected236 at risk EG0020 events0 affected226 at risk
Confusional state	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Depression	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0014 events3 affected236 at risk EG0022 events2 affected226 at risk
Insomnia	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0013 events3 affected236 at risk EG0023 events3 affected226 at risk
Mental disorder	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Panic attack	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Stress	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Anuria	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Bladder cancer	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0015 events5 affected236 at risk EG0021 events1 affected226 at risk
Cystitis	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Dysuria	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Haematuria	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0023 events1 affected226 at risk
Kidney infection	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Nephritis	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Oliguria	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Proteinuria	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0013 events2 affected236 at risk EG0020 events0 affected226 at risk
Pyelonephritis	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Renal failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Renal impairment	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Renal pain	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Urinary retention	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Urinary tract infection	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00017 events13 affected240 at risk EG0016 events5 affected236 at risk EG0028 events6 affected226 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Breast cancer	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Breast cyst	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Prostate cancer	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Testicular disorder	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Uterine leiomyoma	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Acute sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0009 events4 affected240 at risk EG0010 events0 affected236 at risk EG0026 events4 affected226 at risk
Bronchiolitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events8 affected240 at risk EG00119 events16 affected236 at risk EG00210 events9 affected226 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00010 events10 affected240 at risk EG0019 events7 affected236 at risk EG00211 events8 affected226 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Laryngitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0015 events4 affected236 at risk EG0021 events1 affected226 at risk
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00013 events11 affected240 at risk EG00116 events15 affected236 at risk EG00226 events23 affected226 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Pharyngitis streptococcal	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0023 events3 affected226 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0013 events3 affected236 at risk EG0020 events0 affected226 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00010 events10 affected240 at risk EG0015 events5 affected236 at risk EG0024 events4 affected226 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0023 events3 affected226 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00020 events13 affected240 at risk EG00110 events10 affected236 at risk EG0027 events7 affected226 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events3 affected240 at risk EG0011 events1 affected236 at risk EG0023 events3 affected226 at risk
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00016 events13 affected240 at risk EG00113 events12 affected236 at risk EG0029 events8 affected226 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Basal cell carcinoma	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events2 affected240 at risk EG0014 events4 affected236 at risk EG0021 events1 affected226 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0023 events3 affected226 at risk
Cellulitis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0026 events6 affected226 at risk
Contusion	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0022 events2 affected226 at risk
Cutis laxa	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Dermatophytosis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0013 events3 affected236 at risk EG0025 events5 affected226 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Folliculitis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Furuncle	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Herpes zoster	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected240 at risk EG0012 events2 affected236 at risk EG0026 events6 affected226 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Malignant melanoma	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Nail avulsion	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Onychogryphosis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0014 events4 affected236 at risk EG0024 events4 affected226 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Skin abrasion	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Skin bacterial infection	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Skin cancer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0012 events1 affected236 at risk EG0022 events2 affected226 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Skin infection	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0014 events4 affected236 at risk EG0021 events1 affected226 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0013 events3 affected236 at risk EG0022 events2 affected226 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Arterial bypass operation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Benign tumour excision	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Bile duct stent insertion	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Blepharoplasty	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Carpal tunnel decompression	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0012 events2 affected236 at risk EG0021 events1 affected226 at risk
Cataract operation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0021 events1 affected226 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Dental implantation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Endodontic procedure	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0012 events2 affected236 at risk EG0022 events2 affected226 at risk
Hysterectomy	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Knee operation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Metatarsal excision	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Retinal laser coagulation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Shoulder operation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Skin graft	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Skin lesion excision	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Spinal decompression	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Stent placement	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Tooth extraction	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected240 at risk EG0012 events2 affected236 at risk EG0023 events3 affected226 at risk
Transfusion	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Wrist surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0022 events1 affected226 at risk
Carotid artery stenosis	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0010 events0 affected236 at risk EG0021 events1 affected226 at risk
Essential hypertension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Haematoma	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0020 events0 affected226 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00020 events20 affected240 at risk EG00120 events18 affected236 at risk EG00213 events13 affected226 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected240 at risk EG0012 events2 affected236 at risk EG0020 events0 affected226 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Poor peripheral circulation	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected240 at risk EG0010 events0 affected236 at risk EG0022 events2 affected226 at risk
Transient ischaemic attack	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk
Varicose vein	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected240 at risk EG0011 events1 affected236 at risk EG0020 events0 affected226 at risk

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Units	Counts
Participants	BG000226 BG001240 BG002236 BG003702
Eyes	BG000226 BG001240 BG002236 BG003702