Study: NCT04480463

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Study Eye
Frequency: 2 affected / 287 at risk

Adverse event: Retinal pigment epithelial tear
Serious: yes
Organ System: Eye disorders
Notes: Study Eye
Frequency: 2 affected / 287 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: Study Eye
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 287 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Bone tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 287 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 287 at risk

Adverse event: Tenosynovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 287 at risk

Adverse event: Lung adenocarcinoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 287 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 287 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 287 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Intracranial mass
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 287 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 287 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 287 at risk

Adverse event: Age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 2 affected / 287 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 1 affected / 287 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 1 affected / 287 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 5 affected / 287 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 3 affected / 287 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 8 affected / 287 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 3 affected / 287 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 5 affected / 287 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 5 affected / 287 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 3 affected / 287 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 3 affected / 287 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 5 affected / 287 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 20 affected / 287 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 4 affected / 287 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 3 affected / 287 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 1 affected / 287 at risk

Adverse event: Subretinal fluid
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 3 affected / 287 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 11 affected / 287 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 4 affected / 287 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 3 affected / 287 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 5 affected / 287 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 287 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 287 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 287 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Study Eye
Frequency: 3 affected / 287 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Fellow Eye
Frequency: 7 affected / 287 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 287 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 287 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 287 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 287 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 287 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study Eye
Frequency: 5 affected / 287 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 287 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 287 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 287 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 287 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 287 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 287 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 287 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 287 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Study Eye
Frequency: 1 affected / 286 at risk

Adverse event: Amaurosis fugax
Serious: yes
Organ System: Eye disorders
Notes: Study Eye
Frequency: 1 affected / 286 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: Study Eye
Frequency: 1 affected / 286 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 1 affected / 286 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 286 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 286 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 286 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 286 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 286 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 286 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 286 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 286 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 286 at risk

Adverse event: Aspergilloma
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 286 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 286 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 286 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 286 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 286 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 286 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 286 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 286 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 286 at risk

Adverse event: Venom poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 286 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 286 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 286 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 286 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 286 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 286 at risk

Adverse event: Fibroadenoma of breast
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 286 at risk

Adverse event: High-grade B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 286 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 286 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 286 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 286 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 286 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 286 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 286 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 286 at risk

Adverse event: Idiopathic pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 286 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 286 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 286 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 286 at risk

Adverse event: Age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 3 affected / 286 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 3 affected / 286 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 3 affected / 286 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 4 affected / 286 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 3 affected / 286 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 6 affected / 286 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 1 affected / 286 at risk

Adverse event: Corneal erosion
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 4 affected / 286 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 4 affected / 286 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 4 affected / 286 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 3 affected / 286 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 1 affected / 286 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 4 affected / 286 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Fellow Eye
Frequency: 13 affected / 286 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 3 affected / 286 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 1 affected / 286 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 2 affected / 286 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 4 affected / 286 at risk

Adverse event: Subretinal fluid
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 1 affected / 286 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 12 affected / 286 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 1 affected / 286 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 4 affected / 286 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study Eye
Frequency: 3 affected / 286 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 286 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 286 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 286 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 286 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 286 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 286 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 286 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Study Eye
Frequency: 3 affected / 286 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Fellow Eye
Frequency: 2 affected / 286 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 286 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 286 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 286 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study Eye
Frequency: 3 affected / 286 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 286 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 286 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 286 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 286 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 286 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 286 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 286 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 286 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 286 at risk