Study: NCT03038880

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 24 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 24 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 24 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 24 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 24 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 24 at risk

Adverse event: Choroidal neovascularisation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 24 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 24 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk

Adverse event: Anterior chamber flare
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Catheter site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Mycobacterium avium complex infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Catheterisation cardiac
Serious: no
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cerebral infarction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cerebral small vessel ischaemic disease
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Retinal degeneration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Eye naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 24 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 31 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 31 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 31 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Subretinal fibrosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Joint abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Urethritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Inflammatory pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Emphysema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Bladder pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Macular fibrosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Retinal drusen
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vitreous disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 16 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Choroidal neovascularisation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Eye haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Optic disc haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Eye contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Biopsy palate
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 16 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cervical spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Ophthalmological examination abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk