Table 18.

Summary of all Systemic Adverse Events through 2 Years of Follow-up^*

	Sham N = 319	Ranibizumab N = 710	Triamcinolone N=369	Sham/ Ranibizumab N = 321	Sham/ Triamcinolone N = 109
Adverse Event
Blood and lymphatic system disorders
Anaemia	6	4	7	4	2
Anaemia of chronic disease	0	1	1	0	0
Lymphadenopathy	1	0	0	0	0
Lymphoedema	0	2	0	0	0
Lymphoma	0	0	1	0	0
Thrombocytopenia	0	2	0	0	0
Cardiac disorders
Acute coronary syndrome	0	0	1	0	0
Angina pectoris	2	1	2	1	0
Arrhythmia	1	2	1	1	0
Arteriosclerosis coronary artery	3	1	3	1	0
Atrial fibrillation	2	4	0	0	0
Bradycardia	1	3	1	0	0
Cardiac failure	0	1	2	1	0
Cardiac failure congestive	6	14	7	8	2
Cardiomegaly	0	2	0	2	0
Cardiomyopathy	0	1	1	0	0
Chest discomfort	1	0	0	0	0
Coronary artery disease	1	3	1	2	0
Coronary artery occlusion	0	0	1	0	0
Left ventricular hypertrophy	0	0	0	1	0
Mitral valve incompetence	0	1	0	0	0
Mitral valve prolapse	0	0	1	0	0
Myocardial infarction	6	3	5	4	1
Palpitations	0	0	0	1	0
Supraventricular tachycardia	0	1	0	0	0
Tachycardia	0	0	0	2	0
Ear and labyrinth disorders
Deafness	1	2	0	1	0
Ear pain	0	1	0	1	0
Endocrine disorders
Diabetes mellitus inadequate control	0	4	0	2	2
Diabetic gastroparesis	0	0	1	0	0
Diabetic ketoacidosis	0	0	2	3	0
Diabetic ulcer	0	1	0	1	0
Goitre	0	0	1	0	0
Hyperthyroidism	1	0	0	1	0
Hypothyroidism	2	4	2	1	0
Thyroid cancer	0	0	1	0	0
Thyroid neoplasm	1	0	0	0	0
Eye disorders
Conjunctival haemorrhage	1	0	0	0	0
Punctate keratitis	0	1	0	0	0
Visual impairment	1	0	0	0	0
Gastrointestinal disorders
Abdominal pain	3	1	2	2	0
Abdominal pain upper	1	3	1	4	0
Constipation	1	3	2	0	0
Diarrhoea	4	4	6	6	0
Dyspepsia	1	0	1	0	1
Gastric ulcer	0	1	0	1	0
Gastritis	1	1	0	1	1
Gastrointestinal haemorrhage	1	1	0	0	0
Gastrooesophageal reflux disease	3	4	5	0	0
Haematochezia	1	0	0	0	0
Impaired gastric emptying	0	3	0	0	0
Irritable bowel syndrome	0	0	0	1	0
Nausea	4	10	5	3	1
Oesophageal ulcer	0	1	0	0	0
Oesophagitis	0	1	0	1	0
Peptic ulcer	1	1	0	0	0
Rectal haemorrhage	0	0	0	1	0
Salivary gland disorder	0	1	1	0	0
Tooth infection	0	0	1	3	0
Vomiting	2	3	4	1	2
General disorders and administration site conditions
Chest pain	8	10	5	6	0
Chills	2	1	0	0	0
Cyst	1	3	2	1	0
Death	5	5	2	3	0
Fatigue	0	0	1	0	0
Gait disturbance	0	1	0	0	0
Hernia	1	0	1	2	1
Lethargy	0	2	0	0	0
Oedema peripheral	3	8	4	3	3
Pain	0	1	1	0	0
Pyrexia	3	2	0	4	0
Swelling	4	3	1	2	0
Hepatobiliary disorders
Cholecystitis acute	0	1	3	1	0
Cholelithiasis	1	1	0	0	1
Hepatic failure	0	1	1	0	0
Immune system disorders
Asthma	0	1	1	2	0
Drug hypersensitivity	1	0	0	1	0
Hypersensitivity	0	0	2	0	0
Seasonal allergy	4	7	1	4	3
Urticaria	0	1	0	0	0
Infections and infestations
Bronchitis	2	11	7	7	2
Cystitis	3	3	0	2	4
Diverticulitis	2	0	0	0	0
Ear infection	2	7	5	2	3
Fungal infection	1	2	0	1	1
Fungal skin infection	0	0	1	0	0
Gangrene	1	0	1	1	0
Gastroenteritis	1	0	2	0	1
Gastroenteritis viral	1	8	2	4	0
Gingival infection	0	1	0	1	0
Herpes zoster	2	1	4	2	0
Hordeolum	0	0	0	1	0
Infection	1	1	1	3	0
Influenza	4	11	9	11	4
Kidney infection	0	3	1	0	1
Localised infection	1	8	7	3	1
Onychomycosis	1	1	0	1	0
Oral herpes	0	1	0	0	0
Osteomyelitis	0	3	1	0	0
Pharyngitis streptococcal	0	1	1	0	0
Pneumonia	4	14	2	0	2
Respiratory tract infection	0	2	1	1	1
Sepsis	1	3	0	1	0
Sinusitis	2	5	3	3	1
Skin bacterial infection	0	0	1	0	0
Skin infection	1	2	1	0	0
Staphylococcal infection	0	0	0	1	2
Tooth abscess	0	7	4	1	0
Upper respiratory tract infection	2	22	7	7	1
Urinary tract infection	5	16	5	4	3
Injury, poisoning and procedural complications
Accidental overdose	0	0	1	0	0
Animal bite	0	1	0	0	0
Animal scratch	1	0	0	0	0
Arthropod bite	1	0	1	0	1
Arthropod sting	0	1	0	0	0
Asbestosis	0	0	0	0	1
Caustic injury	0	1	0	0	0
Fall	4	14	4	3	2
Fibula fracture	0	1	0	0	0
Food poisoning	0	1	1	2	0
Foot fracture	2	6	2	0	1
Head injury	0	1	0	1	0
Hip fracture	1	1	0	1	1
Joint injury	2	6	4	0	0
Laceration	2	2	1	0	0
Ligament rupture	0	0	0	0	1
Ligament sprain	0	1	0	0	1
Limb injury	1	0	0	1	0
Nerve injury	1	l	1	1	0
Post procedural complication	0	l	1	0	0
Road traffic accident	1	3	0	0	0
Spinal fracture	0	0	0	1	0
Thermal burn	1	0	0	0	0
Wound	0	0	0	0	1
Wrist fracture	0	0	2	0	0
Investigations
Angiogram	1	0	0	0	0
Aortogram	0	1	0	0	0
Arteriogram	0	1	0	0	0
Biopsy thyroid gland	0	1	1	0	0
Blood glucose decreased	0	0	2	0	0
Blood potassium decreased	1	0	0	0	0
Blood potassium increased	2	3	4	1	0
Blood testosterone decreased	0	1	0	0	0
Cardiac murmur	1	0	0	0	0
Colonoscopy	1	0	0	0	0
Heart rate increased	0	1	1	0	0
Heart rate irregular	0	5	1	0	0
Oesophagogastroduodenoscopy	1	0	0	0	0
Weight decreased	1	3	0	0	1
White blood cell count increased	0	1	1	0	0
Metabolism and nutrition disorders
Abnormal weight gain	1	1	0	0	0
Dehydration	2	1	2	0	0
Diabetes mellitus	0	2	2	2	0
Diabetes mellitus inadequate control	0	2	3	0	1
Fluid overload	0	0	1	0	1
Fluid retention	0	0	0	1	0
Hypercholesterolaemia	5	7	4	5	1
Hyperglycaemia	5	6	6	3	1
Hyperkalaemia	0	2	1	1	0
Hyperlipidaemia	0	0	0	1	0
Hypertriglyceridaemia	0	0	0	0	1
Hypogiycaemia	3	11	3	5	5
Iron deficiency	0	1	0	1	0
Oedema peripheral	0	0	0	1	0
Osteoporosis	0	1	2	0	0
Vitamin B12 deficiency	0	1	0	0	0
Vitamin D deficiency	1	1	1	0	1
Musculoskeletal and connective tissue disorders
Arthralgia	5	7	2	4	1
Arthritis	0	1	0	1	0
Back pain	5	9	4	4	1
Bursitis	1	0	0	1	0
Exostosis	1	2	0	0	0
Facial bones fracture	0	1	0	0	0
Fracture	1	2	0	2	1
Gout	1	3	0	4	2
Inclusion body myositis	0	1	0	0	0
Intervertebral disc protrusion	0	3	3	1	0
Joint sprain	0	0	1	0	0
Lower limb fracture	0	1	1	0	0
Multiple fractures	1	0	0	1	0
Muscle spasms	0	0	1	0	0
Muscular weakness	1	3	0	0	0
Musculoskeletal pain	6	4	2	1	0
Myalgia	1	2	2	1	3
Neck pain	3	6	1	1	0
Osteoarthritis	1	2	2	2	1
Osteopenia	0	1	0	0	0
Pain in extremity	5	8	10	3	1
Rhabdomyolysis	0	1	0	0	0
Rheumatoid arthritis	0	3	0	0	0
Rib fracture	1	1	1	1	0
Rotator cuff syndrome	1	1	0	0	0
Spinal osteoarthritis	1	0	0	0	0
Temporomandibular joint syndrome	0	0	0	1	0
Tendonitis	0	1	0	0	0
Trigger finger	1	3	2	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm	1	0	0	0	0
Bladder cancer	0	2	0	0	0
Bone neoplasm malignant	0	1	0	0	0
Brain neoplasm	0	0	0	1	0
Colon cancer	0	2	0	0	0
Colonic polyp	0	1	0	0	0
Lung cancer metastatic	0	1	1	0	0
Multiple myeloma	0	0	0	1	0
Polyp	1	2	2	1	0
Skin cancer	5	2	2	1	0
Nervous system disorders
Amnesia	0	1	0	1	0
Carotid artery occlusion	1	0	0	0	0
Carpal tunnel syndrome	1	2	1	2	0
Cerebrovascular accident	2	3	2	0	0
Concussion	0	0	0	0	1
Convulsion	0	0	1	1	0
Dementia Alzheimer’s type	0	0	0	0	1
Dizziness	6	8	2	2	0
Dysarthria	0	0	0	0	1
Essential tremor	0	0	0	0	1
Facial palsy	1	0	1	0	0
Headache	6	17	8	6	1
Hemiparesis	2	0	0	0	0
Hypoaesthesia	0	0	1	1	1
Insomnia	2	3	1	0	0
Ischaemic stroke	6	2	1	1	0
Migraine	0	2	1	0	0
Neuropathy	0	2	1	0	0
Neuropathy peripheral	2	2	0	1	0
Post herpetic neuralgia	0	0	1	0	0
Presyncope	0	0	0	1	0
Restless legs syndrome	0	1	0	0	0
Sciatica	0	1	0	1	0
Syncope	1	3	4	2	0
Tinnitus	0	1	0	0	0
Tremor	0	1	1	0	0
Vertigo	3	1	2	3	0
Psychiatric disorders
Aggression	0	0	1	0	0
Anxiety	2	4	3	2	2
Bipolar disorder	0	0	1	0	0
Depression	3	8	0	4	0
Drug dependence	0	0	1	0	0
Insomnia	0	1	1	0	0
Mental disorder	1	0	0	0	0
Renal and urinary disorders
Bladder spasm	0	2	0	1	0
Haematuria	0	1	0	0	0
Nephrolithiasis	1	3	1	0	0
Proteinuria	0	1	0	0	0
Renal disorder	0	1	0	0	0
Renal failure	3	11	4	6	2
Renal failure acute	1	1	0	3	0
Renal failure chronic	0	2	3	0	0
Renal impairment	0	7	4	1	0
Urethral stenosis	1	0	0	0	0
Urinary incontinence	0	2	1	1	0
Urinary tract disorder	0	1	0	0	0
Reproductive system and breast disorders
Breast cancer	1	2	0	0	0
Erectile dysfunction	1	0	2	1	0
Prostate cancer	1	2	1	2	0
Prostatitis	0	1	0	0	0
Prostatomegaly	0	2	0	2	1
Respiratory, thoracic and mediastinal disorders
Asthma	0	0	0	1	0
Cardio-respiratory arrest	0	0	1	1	0
Chronic obstructive pulmonary disease	1	1	0	0	1
Cough	2	7	4	4	0
Dyspnoea	3	5	2	5	1
Epistaxis	0	3	0	1	0
Hypoxia	0	1	0	0	0
Lung neoplasm	0	1	0	0	0
Nasopharyngitis	7	29	15	6	2
Oropharyngeal pain	0	1	0	1	0
Pleural effusion	0	0	1	0	0
Pulmonary hypertension	0	1	0	0	0
Pulmonary oedema	1	2	0	3	0
Respiratory distress	0	0	1	0	0
Respiratory tract congestion	1	3	1	1	1
Rhinitis allergic	1	1	1	3	1
Rhinorrhoea	0	0	0	1	0
Sinusitis	4	13	4	6	2
Sleep apnoea syndrome	3	3	3	2	1
Sneezing	0	1	0	0	1
Throat cancer	0	1	0	1	0
Wheezing	0	0	0	0	1
Skin and subcutaneous tissue disorders
Alopecia	0	1	0	0	0
Angioedema	0	1	0	0	0
Blister	0	1	0	0	0
Cellulitis	0	4	3	1	0
Contusion	2	3	0	2	0
Dermatitis contact	0	2	0	1	1
Excoriation	2	0	0	0	0
Furuncle	1	1	0	0	0
Hyperhidrosis	0	1	0	0	0
Hyperkeratosis	0	1	0	0	0
Ingrowing nail	3	1	0	0	0
Pruritus	0	1	0	0	0
Psoriasis	0	0	0	0	1
Rash	0	7	1	1	.
Skin lesion	2	0	0	1	1
Skin ulcer	2	14	6	5	0
Subcutaneous abscess	0	1	0	0	0
Swelling face	1	0	0	0	0
Tinea capitis	0	0	0	1	0
Surgical and medical procedures
Arterial bypass operation	0	1	1	0	0
Benign tumour excision	1	0	0	0	0
Cholecystectomy	1	0	0	0	0
Coronary arterial stent insertion	0	2	1	1	0
Gastric bypass	0	0	1	2	0
Hysterectomy	0	0	1	0	0
Knee operation	0	0	1	0	1
Leg amputation	1	0	0	0	0
Shoulder operation	0	1	0	0	0
Skin lesion excision	0	3	0	0	0
Stent placement	1	1	1	2	0
Toe amputation	0	0	1	0	0
Tooth extraction	1	5	2	1	0
Vascular graft	0	1	0	1	0
Wrist surgery	0	1	0	0	1
Vascular disorders
Arterial occiusive disease	0	2	0	0	0
Arteriosclerosis	1	0	0	0	0
Arteriovenous fistula	1	1	3	0	0
Carotid artery stenosis	0	3	0	0	0
Cerebral haemorrhage	0	0	0	0	1
Deep vein thrombosis	1	1	0	0	0
Embolism	1	0	0	0	0
Hypertension	3	16	6	9	2
Hypotension	2	4	1	1	0
Iliac artery occlusion	1	0	0	0	0
Orthostatic hypotension	0	1	1	0	0
Peripheral vascular disorder	3	1	1	0	1
Poor peripheral circulation	0	0	1	0	0
Pulmonary embolism	0	1	1	0	0
Thrombosis	0	0	1	0	0
Transient ischaemic attack	2	1	0	0	0
Varicose vein	0	1	0	0	0

^*Comprehensive list of alt systemic adverse events as reported by the site using the Medical Dictionary for Regulatory Activities coding.