Safety and Efficacy of Abicipar Pegol in Participants Wit... | NCT02462486

ID	Type	Description	Link
2014-004580-20	EudraCT Number
SEQUOIA	Other Identifier	Allergan

Label	Type	Description	Intervention Names
Abicipar Pegol 2 mg (2Q8)	Experimental	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Drug: Abicipar Pegol Other: Sham Procedure
Abicipar Pegol 2 mg (2Q12)	Experimental	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Drug: Abicipar Pegol Other: Sham Procedure
Ranibizumab (rQ4)	Active Comparator	Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.	Drug: Ranibizumab

Name	Type	Description	Arm Group Labels	Other Names
Abicipar Pegol	Drug	Abicipar pegol intravitreal injection.	Abicipar Pegol 2 mg (2Q12) Abicipar Pegol 2 mg (2Q8)

Measure	Description	Time Frame
Percentage of Participants With Stable Vision at Week 52	Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.	Baseline to Week 52

Measure	Description	Time Frame
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52	BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

Name	Affiliation	Role
Joanne Li	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Eye Foundation Hospital		Birmingham	Alabama	35233	United States
Retinal Consultants of Arizona

ID	Title	Description
FG000	Abicipar Pegol 2 mg (2Q8)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	May 16, 2018	Jul 17, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Stable Vision at Week 52

Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

Per Protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.

Posted

Number

percentage of participants

Baseline to Week 52

ID	Title	Description
OG000	Abicipar Pegol 2 mg (2Q8)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
OG001	Abicipar Pegol 2 mg (2Q12)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
OG002	Ranibizumab (rQ4)	Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.

Units	Counts
Participants	OG000267 OG001265 OG002299

Title

Denominators

Categories

Title	Measurements
	OG00094.8 OG00191.3 OG00296.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002						Percentage Difference	-1.2			2-Sided	95	-5.0	2.4			The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs >55 letters) as stratification factor.		Non-Inferiority	For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.

Secondary

Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52

BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

PP population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately. Number of participants analyzed was based on observed data; missing data were not imputed.

Posted

Mean

Standard Deviation

letters

Baseline to Week 52

ID	Title	Description
OG000	Abicipar Pegol 2 mg (2Q8)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
OG001

Secondary

Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52

CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye. MMRM analysis was used.

Intent-to-treat (ITT) Population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed.

Posted

Mean

Standard Deviation

microns

Baseline to Week 52

ID	Title	Description
OG000	Abicipar Pegol 2 mg (2Q8)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
OG001	Abicipar Pegol 2 mg (2Q12)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Secondary

Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52

BCVA is measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA gain of more than 15 letters are noted. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

ITT Population included all randomized participants.

Posted

Number

percentage of participants

Baseline to Week 52

ID	Title	Description
OG000	Abicipar Pegol 2 mg (2Q8)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
OG001	Abicipar Pegol 2 mg (2Q12)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Secondary

Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52

NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.

ITT population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed.

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline to Week 52

ID	Title	Description
OG000	Abicipar Pegol 2 mg (2Q8)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG0003 affected313 at risk EG0015 affected314 at risk EG0025 affected315 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0002 affected313 at risk EG0013 affected314 at risk EG0025 affected315 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0012 affected314 at risk EG0023 affected315 at risk
Coronary artery disease	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0022 affected315 at risk
Arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0022 affected315 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0022 affected315 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 affected313 at risk EG0014 affected314 at risk EG0021 affected315 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0021 affected315 at risk
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Myocardial oedema	Cardiac disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0012 affected314 at risk EG0020 affected315 at risk
Myocardial ischaemia	Cardiac disorders	Systematic Assessment	EG0002 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Aortic valve disease	Cardiac disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Atrioventricular block complete	Cardiac disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Aortic valve incompetence	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Aortic valve stenosis	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Atrioventricular block second degree	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Coronary artery occlusion	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Mitral valve incompetence	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Vertigo positional	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0021 affected315 at risk
Meniere's disease	Ear and labyrinth disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Retinal haemorrhage	Eye disorders	Systematic Assessment	EG0002 affected313 at risk EG0010 affected314 at risk EG0025 affected315 at risk
Retinal detachment	Eye disorders	Systematic Assessment	EG0003 affected313 at risk EG0010 affected314 at risk EG0022 affected315 at risk
Cataract	Eye disorders	Systematic Assessment	EG0002 affected313 at risk EG0013 affected314 at risk EG0021 affected315 at risk
Vitreous haemorrhage	Eye disorders	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0021 affected315 at risk
Retinal fibrosis	Eye disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Retinal pigment epithelial tear	Eye disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Uveitis	Eye disorders	Systematic Assessment	EG0007 affected313 at risk EG0014 affected314 at risk EG0020 affected315 at risk
Retinal vasculitis	Eye disorders	Systematic Assessment	EG0004 affected313 at risk EG0014 affected314 at risk EG0020 affected315 at risk
Visual acuity reduced	Eye disorders	Systematic Assessment	EG0001 affected313 at risk EG0013 affected314 at risk EG0020 affected315 at risk
Vitritis	Eye disorders	Systematic Assessment	EG0004 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Iridocyclitis	Eye disorders	Systematic Assessment	EG0002 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Retinal artery occlusion	Eye disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Age-related macular degeneration	Eye disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Autoimmune uveitis	Eye disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Choroidal neovascularisation	Eye disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Neovascular age-related macular degeneration	Eye disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Retinal vein occlusion	Eye disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Anterior chamber inflammation	Eye disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Keratitis	Eye disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Macular hole	Eye disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Serous retinal detachment	Eye disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0021 affected315 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Diverticulum	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Intestinal perforation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0020 affected315 at risk
Intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Pancreatitis acute	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Duodenal ulcer	Gastrointestinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Large intestine polyp	Gastrointestinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Pharyngo-oesophageal diverticulum	Gastrointestinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Peripheral swelling	General disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Asthenia	General disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Death	General disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Cholecystitis acute	Hepatobiliary disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Drug hypersensitivity	Immune system disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0004 affected313 at risk EG0013 affected314 at risk EG0028 affected315 at risk
Diverticulitis	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0022 affected315 at risk
Endophthalmitis	Infections and infestations	Systematic Assessment	EG0005 affected313 at risk EG0014 affected314 at risk EG0021 affected315 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0002 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Abdominal abscess	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Arteritis infective	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Enterocolitis viral	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Gastrointestinal infection	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Infective aortitis	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Pneumonia staphylococcal	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Cytomegalovirus infection	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Pneumonia bacterial	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Pneumonia escherichia	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Pneumonia pneumococcal	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Pyelonephritis acute	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Septic shock	Infections and infestations	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0003 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0002 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Cellulitis staphylococcal	Infections and infestations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Clostridium difficile colitis	Infections and infestations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Diarrhoea infectious	Infections and infestations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Infectious colitis	Infections and infestations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Pulmonary sepsis	Infections and infestations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 affected313 at risk EG0013 affected314 at risk EG0023 affected315 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0022 affected315 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0021 affected315 at risk
Animal bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Concussion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Multiple fractures	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Scrotal haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Synovial rupture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Tibia fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0020 affected315 at risk
Foot fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Hand fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Incisional hernia	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Lower limb fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Radius fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Road traffic accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Skin laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Skin wound	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Wrist fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Femur fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Head injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Troponin increased	Investigations	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Intraocular pressure increased	Investigations	Systematic Assessment	EG0001 affected313 at risk EG0012 affected314 at risk EG0020 affected315 at risk
Heart rate decreased	Investigations	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Monoclonal immunoglobulin present	Investigations	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Blood glucose abnormal	Investigations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Blood pressure increased	Investigations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Pulmonary function test decreased	Investigations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Urine electrolytes decreased	Investigations	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected313 at risk EG0012 affected314 at risk EG0021 affected315 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Malnutrition	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Fluid overload	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected313 at risk EG0011 affected314 at risk EG0022 affected315 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Bone loss	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Foot fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Bursitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 affected313 at risk EG0013 affected314 at risk EG0026 affected315 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0022 affected315 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0022 affected315 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0021 affected315 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Retroperitoneal neoplasm metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0020 affected315 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Squamous cell carcinoma of head and neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Oropharyngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0023 affected315 at risk
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0013 affected314 at risk EG0021 affected315 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0021 affected315 at risk
Brain stem stroke	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Cerebral haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Lumbar radiculopathy	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Piriformis syndrome	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Seizure	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Amnesia	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Optic neuritis	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Peroneal nerve palsy	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Radiculopathy	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Vertebral artery occlusion	Nervous system disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Carotid artery occlusion	Nervous system disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Carotid artery stenosis	Nervous system disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Carpal tunnel syndrome	Nervous system disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Speech disorder	Nervous system disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Vascular dementia	Nervous system disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Hallucination	Psychiatric disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Mental status changes	Psychiatric disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Gynaecomastia	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Prostatomegaly	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected313 at risk EG0013 affected314 at risk EG0023 affected315 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0012 affected314 at risk EG0022 affected315 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0022 affected315 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0021 affected315 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0021 affected315 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0021 affected315 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0020 affected315 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0022 affected315 at risk
Aortic stenosis	Vascular disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0021 affected315 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Hypertensive crisis	Vascular disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Shock haemorrhagic	Vascular disorders	Systematic Assessment	EG0000 affected313 at risk EG0010 affected314 at risk EG0021 affected315 at risk
Aortic aneurysm	Vascular disorders	Systematic Assessment	EG0000 affected313 at risk EG0012 affected314 at risk EG0020 affected315 at risk
Blood pressure inadequately controlled	Vascular disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Peripheral ischaemia	Vascular disorders	Systematic Assessment	EG0000 affected313 at risk EG0011 affected314 at risk EG0020 affected315 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0002 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Aortic aneurysm rupture	Vascular disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Lymphoedema	Vascular disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk
Peripheral artery aneurysm	Vascular disorders	Systematic Assessment	EG0001 affected313 at risk EG0010 affected314 at risk EG0020 affected315 at risk

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Abicipar Pegol 2 mg (2Q8)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
BG001	Abicipar Pegol 2 mg (2Q12)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
BG002	Ranibizumab (rQ4)	Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Abicipar Pegol 2 mg (2Q8)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	11	313	94	313	168	313
EG001	Abicipar Pegol 2 mg (2Q12)	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	6	314	83	314	166	314
EG002	Ranibizumab (rQ4)	Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.	7	315	78	315	166	315

Term	Organ System	Assessment Type	Statistical Information
Eye pain	Eye disorders	Systematic Assessment	EG00037 affected313 at risk EG00135 affected314 at risk EG00236 affected315 at risk
Conjunctival haemorrhage	Eye disorders	Systematic Assessment	EG00024 affected313 at risk EG00129 affected314 at risk EG00229 affected315 at risk
Conjunctival hyperaemia	Eye disorders	Systematic Assessment	EG00017 affected313 at risk EG00115 affected314 at risk EG00223 affected315 at risk
Neovascular age-related macular degeneration	Eye disorders	Systematic Assessment	EG00018 affected313 at risk EG00125 affected314 at risk EG00221 affected315 at risk
Vitreous floaters	Eye disorders	Systematic Assessment	EG00027 affected313 at risk EG00130 affected314 at risk EG00217 affected315 at risk
Vitreous detachment	Eye disorders	Systematic Assessment	EG00016 affected313 at risk EG00117 affected314 at risk EG00211 affected315 at risk
Visual acuity reduced	Eye disorders	Systematic Assessment	EG00017 affected313 at risk EG00115 affected314 at risk EG0026 affected315 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG00033 affected313 at risk EG00135 affected314 at risk EG00240 affected315 at risk
Influenza	Infections and infestations	Systematic Assessment	EG00019 affected313 at risk EG00115 affected314 at risk EG00222 affected315 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG00022 affected313 at risk EG00121 affected314 at risk EG00212 affected315 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG00013 affected313 at risk EG00114 affected314 at risk EG00222 affected315 at risk
Intraocular pressure increased	Investigations	Systematic Assessment	EG00029 affected313 at risk EG00129 affected314 at risk EG00220 affected315 at risk
Headache	Nervous system disorders	Systematic Assessment	EG00011 affected313 at risk EG00118 affected314 at risk EG00217 affected315 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG00018 affected313 at risk EG00122 affected314 at risk EG00216 affected315 at risk