Efficacy and Safety of Ranibizumab in Two "Treat and Exte... | NCT01171976

ID	Type	Description	Link
2010-019795-74	EudraCT Number

Label	Type	Description	Intervention Names
TE Ranibizumab 0.5 mg and Laser	Experimental	On Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections. Laser therapy was applied at Day 1. It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months. Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection.	Drug: Ranibizumab
TE Ranibizumab 0.5 mg alone	Experimental	Patients received ranibizumab intravitreal injection therapy only.	Drug: Ranibizumab
PRN Ranibizumab 0.5 mg	Active Comparator	Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.	Drug: Ranibizumab

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab	Drug	Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.

Measure	Description	Time Frame
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12	Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.	Baseline to Month 12

Measure	Description	Time Frame
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24	Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.	Baseline to Month 24

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Ghent		9000	Belgium
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
26453639	Derived	Prunte C, Fajnkuchen F, Mahmood S, Ricci F, Hatz K, Studnicka J, Bezlyak V, Parikh S, Stubbings WJ, Wenzel A, Figueira J; RETAIN Study Group. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br J Ophthalmol. 2016 Jun;100(6):787-95. doi: 10.1136/bjophthalmol-2015-307249. Epub 2015 Oct 9.

ID	Title	Description
FG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
FG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab

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

Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12

Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.

Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.

Posted

Mean

Standard Deviation

Letters

Baseline to Month 12

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab
OG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Units	Counts
Participants	OG000117 OG001125 OG002117

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00062.3± 11.50 OG00164.1± 10.52 OG00265.1± 10.08

Average Month 1 to Month 12

Secondary

Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24

Posted

Mean

Standard Deviation

Letters

Baseline to Month 24

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab
OG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Secondary

Visual Acuity of the Study Eye: Change From Baseline at Month 12

Posted

Mean

Standard Deviation

Letters

Baseline and Month 12

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab
OG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Secondary

Visual Acuity of the Study Eye: Change From Baseline at Month 24

Posted

Mean

Standard Deviation

Letters

Baseline and Month 24

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab
OG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Secondary

Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12

Posted

Number

Percentage of patients

Baseline, Month 12

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab
OG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Secondary

Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24

Posted

Number

Percentage of pateints

Baseline, 24 month

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab
OG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Secondary

Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12

High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.

Posted

Mean

Standard Deviation

Percent Change

Baseline, Month 12

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab
OG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Secondary

Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24

Posted

Mean

Standard Deviation

Percent Change

Baseline and 24 month

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab
OG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Secondary

Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24

The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning

Posted

Mean

Standard Deviation

Score on a scale

Baseline, Month 12 and Month 24

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab

Secondary

EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24

The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= "no problems", 2="some problems" and 3="extreme problems" . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction

Posted

Mean

Standard Deviation

Score on a scale

Baseline, Month 12 and Month 24

ID	Title	Description
OG000	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
OG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Hypocoagulable state	Blood and lymphatic system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Acute myocardial infarction	Cardiac disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Angina pectoris	Cardiac disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Atrial fibrillation	Cardiac disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Atrioventricular block	Cardiac disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Bradycardia	Cardiac disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Cardiac failure	Cardiac disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Cardiac failure acute	Cardiac disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Cardiac failure congestive	Cardiac disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Cardiovascular disorder	Cardiac disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Coronary artery disease	Cardiac disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Myocardial infarction	Cardiac disorders	16.0	Systematic Assessment	EG0004 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Myocardial ischaemia	Cardiac disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Hydrocele	Congenital, familial and genetic disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Meniere's disease	Ear and labyrinth disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Cataract (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Macular fibrosis (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Vitreous adhesions (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Vitreous haemorrhage (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Abdominal hernia	Gastrointestinal disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Ascites	Gastrointestinal disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Duodenitis	Gastrointestinal disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Pancreatitis chronic	Gastrointestinal disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Small intestine ulcer	Gastrointestinal disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Tooth loss	Gastrointestinal disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Chest pain	General disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Malaise	General disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Oedema peripheral	General disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Bile duct stenosis	Hepatobiliary disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Cholecystitis	Hepatobiliary disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Cholelithiasis	Hepatobiliary disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Gallbladder perforation	Hepatobiliary disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Hepatic cirrhosis	Hepatobiliary disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Jaundice cholestatic	Hepatobiliary disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Acarodermatitis	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Bacterascites	Infections and infestations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Cellulitis	Infections and infestations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Diabetic gangrene	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Endophthalmitis (Study eye)	Infections and infestations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Endophthalmitis (Treated non-study eye)	Infections and infestations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Gastroenteritis viral	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Infected skin ulcer	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Lower respiratory tract infection	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Orchitis	Infections and infestations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Pneumonia	Infections and infestations	16.0	Systematic Assessment	EG0003 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Renal abscess	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Urinary tract infection	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Wound infection	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Contusion	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Facial bones fracture	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Fibula fracture	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Foot fracture	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Joint dislocation	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Meniscus injury	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Patella fracture	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Periorbital haematoma (Study eye)	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Rib fracture	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Scapula fracture	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Blood glucose increased	Investigations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Blood urine present	Investigations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
International normalised ratio increased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Diabetes mellitus	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Hyperglycaemia	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Hypoglycaemia	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Ketoacidosis	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Metastases to soft tissue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Aphasia	Nervous system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Carotid artery stenosis	Nervous system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Cerebral infarction	Nervous system disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Cerebrovascular accident	Nervous system disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0023 affected118 at risk
Cerebrovascular disorder	Nervous system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Hepatic encephalopathy	Nervous system disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Hypertensive encephalopathy	Nervous system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Hypoaesthesia	Nervous system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Myelopathy	Nervous system disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Status epilepticus	Nervous system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Transient ischaemic attack	Nervous system disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Confusional state	Psychiatric disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Haematuria	Renal and urinary disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Nephrotic syndrome	Renal and urinary disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Renal failure	Renal and urinary disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Renal impairment	Renal and urinary disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Renal mass	Renal and urinary disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Urinary retention	Renal and urinary disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Uterine prolapse	Reproductive system and breast disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Arterial occlusive disease	Vascular disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Arteriosclerosis	Vascular disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Diabetic macroangiopathy	Vascular disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Diabetic vascular disorder	Vascular disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Haematoma	Vascular disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Hypertension	Vascular disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Hypotension	Vascular disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Peripheral ischaemia	Vascular disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	16.0	Systematic Assessment	EG0004 affected126 at risk EG0015 affected126 at risk EG0024 affected118 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Cardiovascular insufficiency	Cardiac disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Vertigo	Ear and labyrinth disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0024 affected118 at risk
Blepharitis (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Blindness transient (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Cataract (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0014 affected126 at risk EG0022 affected118 at risk
Cataract (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0005 affected126 at risk EG0017 affected126 at risk EG0027 affected118 at risk
Cataract (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0013 affected126 at risk EG0021 affected118 at risk
Cataract subcapsular (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Conjunctival haemorrhage (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0005 affected126 at risk EG00111 affected126 at risk EG0026 affected118 at risk
Conjunctival haemorrhage (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Conjunctivitis (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0006 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Corneal disorder (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Diabetic retinal oedema (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0023 affected118 at risk
Diabetic retinal oedema (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0004 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Diabetic retinal oedema (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0023 affected118 at risk
Diabetic retinopathy (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0023 affected118 at risk
Dry eye (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0010 affected126 at risk EG0023 affected118 at risk
Dry eye (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0006 affected126 at risk EG0013 affected126 at risk EG0024 affected118 at risk
Dry eye (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Eye haemorrhage (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Eye irritation (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0014 affected126 at risk EG0022 affected118 at risk
Eye pain (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Eye pain (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0008 affected126 at risk EG0017 affected126 at risk EG0023 affected118 at risk
Eye pain (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Eye pruritus (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0023 affected118 at risk
Eye pruritus (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0012 affected126 at risk EG0022 affected118 at risk
Eye pruritus (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Eyelid oedema (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Eyelid oedema (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0022 affected118 at risk
Foreign body sensation in eyes (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Glaucoma (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Keratitis (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0013 affected126 at risk EG0020 affected118 at risk
Lacrimation increased (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0014 affected126 at risk EG0020 affected118 at risk
Macular fibrosis (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Macular fibrosis (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Macular fibrosis (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Macular oedema (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0016 affected126 at risk EG0023 affected118 at risk
Macular oedema (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0013 affected126 at risk EG0022 affected118 at risk
Macular oedema (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0013 affected126 at risk EG0020 affected118 at risk
Ocular hyperaemia (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Ocular hypertension (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Ocular hypertension (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0007 affected126 at risk EG0012 affected126 at risk EG0023 affected118 at risk
Posterior capsule opacification (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Punctate keratitis (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Retinal exudates (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Retinal exudates (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0022 affected118 at risk
Retinal haemorrhage (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0013 affected126 at risk EG0020 affected118 at risk
Retinal haemorrhage (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Retinal neovascularisation (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0014 affected126 at risk EG0023 affected118 at risk
Retinal vascular disorder (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Retinal vascular disorder (Treated non-study eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Visual acuity reduced (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0022 affected118 at risk
Visual impairment (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Vitreous floaters (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0024 affected118 at risk
Vitreous haemorrhage (Fellow eye)	Eye disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0014 affected126 at risk EG0021 affected118 at risk
Vitreous haemorrhage (Study eye)	Eye disorders	16.0	Systematic Assessment	EG0008 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Abdominal pain upper	Gastrointestinal disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Constipation	Gastrointestinal disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Diarrhoea	Gastrointestinal disorders	16.0	Systematic Assessment	EG0004 affected126 at risk EG0014 affected126 at risk EG0027 affected118 at risk
Gastritis	Gastrointestinal disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Nausea	Gastrointestinal disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0023 affected118 at risk
Vomiting	Gastrointestinal disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0014 affected126 at risk EG0023 affected118 at risk
Fatigue	General disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
General physical health deterioration	General disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Influenza like illness	General disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Malaise	General disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Oedema peripheral	General disorders	16.0	Systematic Assessment	EG0007 affected126 at risk EG0015 affected126 at risk EG0023 affected118 at risk
Pain	General disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Pyrexia	General disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0013 affected126 at risk EG0023 affected118 at risk
Hypersensitivity	Immune system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Bronchitis	Infections and infestations	16.0	Systematic Assessment	EG00011 affected126 at risk EG0011 affected126 at risk EG0025 affected118 at risk
Bronchitis viral	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Cellulitis	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0015 affected126 at risk EG0021 affected118 at risk
Conjunctivitis viral (Study eye)	Infections and infestations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Cystitis	Infections and infestations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0012 affected126 at risk EG0026 affected118 at risk
Ear infection	Infections and infestations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0023 affected118 at risk
Gastroenteritis	Infections and infestations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Gastroenteritis viral	Infections and infestations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Herpes zoster	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0013 affected126 at risk EG0021 affected118 at risk
Hordeolum (Study eye)	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Influenza	Infections and infestations	16.0	Systematic Assessment	EG0009 affected126 at risk EG00110 affected126 at risk EG0028 affected118 at risk
Laryngitis	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Localised infection	Infections and infestations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Lower respiratory tract infection	Infections and infestations	16.0	Systematic Assessment	EG0003 affected126 at risk EG0013 affected126 at risk EG0023 affected118 at risk
Nasopharyngitis	Infections and infestations	16.0	Systematic Assessment	EG00011 affected126 at risk EG00110 affected126 at risk EG0028 affected118 at risk
Paronychia	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Pneumonia	Infections and infestations	16.0	Systematic Assessment	EG0003 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Respiratory tract infection	Infections and infestations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Sinusitis	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0013 affected126 at risk EG0021 affected118 at risk
Skin infection	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0013 affected126 at risk EG0020 affected118 at risk
Tooth abscess	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0022 affected118 at risk
Tooth infection	Infections and infestations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Upper respiratory tract infection	Infections and infestations	16.0	Systematic Assessment	EG0003 affected126 at risk EG0015 affected126 at risk EG0024 affected118 at risk
Urinary tract infection	Infections and infestations	16.0	Systematic Assessment	EG0009 affected126 at risk EG00110 affected126 at risk EG0025 affected118 at risk
Viral infection	Infections and infestations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Contusion	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Fall	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Laceration	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Ligament sprain	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0000 affected126 at risk EG0013 affected126 at risk EG0020 affected118 at risk
Limb injury	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Muscle rupture	Injury, poisoning and procedural complications	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0022 affected118 at risk
Alanine aminotransferase increased	Investigations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Aspartate aminotransferase increased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Blood alkaline phosphatase increased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0024 affected118 at risk
Blood bilirubin increased	Investigations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Blood creatinine increased	Investigations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0014 affected126 at risk EG0020 affected118 at risk
Blood glucose increased	Investigations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0013 affected126 at risk EG0023 affected118 at risk
Blood lactate dehydrogenase increased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0014 affected126 at risk EG0023 affected118 at risk
Blood potassium increased	Investigations	16.0	Systematic Assessment	EG0003 affected126 at risk EG0014 affected126 at risk EG0022 affected118 at risk
Blood urea increased	Investigations	16.0	Systematic Assessment	EG0003 affected126 at risk EG0014 affected126 at risk EG0022 affected118 at risk
Blood uric acid increased	Investigations	16.0	Systematic Assessment	EG0003 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Blood urine present	Investigations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0013 affected126 at risk EG0024 affected118 at risk
Gamma-glutamyltransferase increased	Investigations	16.0	Systematic Assessment	EG0003 affected126 at risk EG0016 affected126 at risk EG0024 affected118 at risk
Glycosylated haemoglobin increased	Investigations	16.0	Systematic Assessment	EG0000 affected126 at risk EG0012 affected126 at risk EG0022 affected118 at risk
Haematocrit decreased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Haemoglobin decreased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0014 affected126 at risk EG0021 affected118 at risk
Intraocular pressure increased (Fellow eye)	Investigations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Intraocular pressure increased (Study eye)	Investigations	16.0	Systematic Assessment	EG0002 affected126 at risk EG0017 affected126 at risk EG0025 affected118 at risk
Platelet count decreased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0023 affected118 at risk
Protein total increased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Red blood cell count decreased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
White blood cell count increased	Investigations	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Diabetes mellitus	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0005 affected126 at risk EG0013 affected126 at risk EG0024 affected118 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0014 affected126 at risk EG0024 affected118 at risk
Gout	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0023 affected118 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0013 affected126 at risk EG0023 affected118 at risk
Hyperglycaemia	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0006 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Hyperkalaemia	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Hypoglycaemia	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0005 affected126 at risk EG0014 affected126 at risk EG0021 affected118 at risk
Ketosis	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0014 affected126 at risk EG0020 affected118 at risk
Arthritis	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0004 affected126 at risk EG0014 affected126 at risk EG0020 affected118 at risk
Back pain	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0008 affected126 at risk EG00110 affected126 at risk EG0023 affected118 at risk
Myalgia	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Neck pain	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0011 affected126 at risk EG0024 affected118 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0003 affected126 at risk EG0012 affected126 at risk EG0023 affected118 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Diabetic neuropathy	Nervous system disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Dizziness	Nervous system disorders	16.0	Systematic Assessment	EG0004 affected126 at risk EG0012 affected126 at risk EG0022 affected118 at risk
Headache	Nervous system disorders	16.0	Systematic Assessment	EG0004 affected126 at risk EG0011 affected126 at risk EG0024 affected118 at risk
Hypoglycaemic coma	Nervous system disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Loss of consciousness	Nervous system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Neuralgia	Nervous system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Sciatica	Nervous system disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Syncope	Nervous system disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Depression	Psychiatric disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0023 affected118 at risk
Insomnia	Psychiatric disorders	16.0	Systematic Assessment	EG0004 affected126 at risk EG0010 affected126 at risk EG0021 affected118 at risk
Renal failure	Renal and urinary disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0012 affected126 at risk EG0021 affected118 at risk
Renal impairment	Renal and urinary disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0010 affected126 at risk EG0022 affected118 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Cough	Respiratory, thoracic and mediastinal disorders	16.0	Systematic Assessment	EG0005 affected126 at risk EG0014 affected126 at risk EG0024 affected118 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0012 affected126 at risk EG0022 affected118 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0010 affected126 at risk EG0020 affected118 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	16.0	Systematic Assessment	EG0000 affected126 at risk EG0013 affected126 at risk EG0020 affected118 at risk
Eczema	Skin and subcutaneous tissue disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0011 affected126 at risk EG0022 affected118 at risk
Rash	Skin and subcutaneous tissue disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0020 affected118 at risk
Hypertension	Vascular disorders	16.0	Systematic Assessment	EG00019 affected126 at risk EG00117 affected126 at risk EG0028 affected118 at risk
Hypotension	Vascular disorders	16.0	Systematic Assessment	EG0001 affected126 at risk EG0012 affected126 at risk EG0020 affected118 at risk
Venous insufficiency	Vascular disorders	16.0	Systematic Assessment	EG0002 affected126 at risk EG0011 affected126 at risk EG0021 affected118 at risk

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	TE Ranibizumad 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.
BG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab
BG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TE Ranibizumab 0.5 mg and Laser	Patients received an injection ranibizumab and laser therapy.	34	126	98	126
EG001	TE Ranibizumab 0.5 mg Alone	Patients received an intravitreal injection ranibizumab	29	126	101	126
EG002	PRN Ranibizumab 0.5 mg	Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.	26	118	78	118