Study: NCT00943072

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 114 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 114 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 114 at risk

Adverse event: Abdominal adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: Ocular AE Study Eye
Frequency: 1 affected / 114 at risk

Adverse event: Corneal abrasion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Ocular AE Study Eye
Frequency: 1 affected / 114 at risk

Adverse event: Abnormal loss of weight
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 114 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 6 affected / 114 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 16 affected / 114 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 10 affected / 114 at risk

Adverse event: Optic disc vascular disorder
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 8 affected / 114 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 7 affected / 114 at risk

Adverse event: Retinal vascular disorder
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 6 affected / 114 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 7 affected / 114 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 6 affected / 114 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 114 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 74 at risk

Adverse event: Oesophageal adenocarcinoma stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 74 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 74 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 74 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 2 affected / 74 at risk

Adverse event: Iris neovascularisation
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 2 affected / 74 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 74 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 74 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 74 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 74 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 74 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 4 affected / 74 at risk

Adverse event: Iris neovascularisation
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 4 affected / 74 at risk

Adverse event: Retinal vascular disorder
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 4 affected / 74 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 12 affected / 74 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 5 affected / 74 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 74 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Metastatic renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 110 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 110 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 110 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Fellow Eye
Frequency: 1 affected / 110 at risk

Adverse event: Conjunctival haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Fellow Eye
Frequency: 1 affected / 110 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 2 affected / 110 at risk

Adverse event: Macular fibrosis
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Fellow Eye
Frequency: 1 affected / 110 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 110 at risk

Adverse event: Posterior capsule opacification
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Fellow Eye
Frequency: 1 affected / 110 at risk

Adverse event: Retinal vascular disorder
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 110 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 110 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 110 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Fellow Eye
Frequency: 1 affected / 110 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 110 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 110 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 110 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Bacteriuria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 110 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Ocular AE Fellow Eye
Frequency: 1 affected / 110 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Renal haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Spinal column injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Notes: Ocular AE Fellow Eye
Frequency: 1 affected / 110 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 110 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 110 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 110 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Haemorrhagic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 110 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Dermatitis contact
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 110 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Fellow Eye
Frequency: 6 affected / 110 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 14 affected / 110 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 9 affected / 110 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 20 affected / 110 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 6 affected / 110 at risk

Adverse event: Optic disc vascular disorder
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 6 affected / 110 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Fellow Eye
Frequency: 6 affected / 110 at risk

Adverse event: Retinal vascular disorder
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 8 affected / 110 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 27 affected / 110 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 8 affected / 110 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 110 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 110 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 110 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pernicious anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 60 at risk

Adverse event: Mantle cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 60 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 60 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 1 affected / 60 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal motility disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Adhesion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Herpes oesophagitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Ocular AE Fellow Eye
Frequency: 1 affected / 60 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 60 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 60 at risk

Adverse event: Rectocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 60 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 60 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 4 affected / 60 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 4 affected / 60 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 4 affected / 60 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 4 affected / 60 at risk

Adverse event: Optic disc vascular disorder
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 5 affected / 60 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 5 affected / 60 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Fellow Eye
Frequency: 4 affected / 60 at risk

Adverse event: Retinal pigment epitheliopathy
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 12 affected / 60 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Ocular AE Study Eye
Frequency: 8 affected / 60 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Ocular AE Fellow Eye
Frequency: 4 affected / 60 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 5 affected / 60 at risk