Study: NCT04485546

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Corneal dystrophy
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: 2 Participants - 1 Case is OU (oculus uterque)
Frequency: 2 affected / 37 at risk

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Notes: 2 Participants - 1 Case is OU (oculus uterque)
Frequency: 2 affected / 37 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 37 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: 4 Participants - 2 Cases are OU (oculus uterque)
Frequency: 4 affected / 37 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: 3 Participants - 2 Cases are OU (oculus uterque)
Frequency: 3 affected / 37 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: 14 Participants - 2 Cases are OU (oculus uterque)
Frequency: 14 affected / 37 at risk

Adverse event: Eyelid disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Eyelid irritation
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Eyelid margin crusting
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Eyelid pain
Serious: no
Organ System: Eye disorders
Notes: 3 Participants - 2 Cases are OU (oculus uterque)
Frequency: 3 affected / 37 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 37 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Notes: 2 Participants - 1 Case is OU (oculus uterque)
Frequency: 2 affected / 37 at risk

Adverse event: Neurotrophic keratopathy
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Periorbital pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: 7 Participants - 3 Cases are OU (oculus uterque)
Frequency: 7 affected / 37 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Secretion discharge
Serious: no
Organ System: General disorders
Notes: 2 Participants - 1 Case is OU (oculus uterque)
Frequency: 2 affected / 37 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Herpes ophthalmic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Ophthalmic herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Ophthalmic herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Persistent corneal epithelial defect
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Apraxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Notes: 3 Participants - 1 Case is OU (oculus uterque)
Frequency: 3 affected / 37 at risk

Adverse event: Corneal dystrophy
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: 2 Participants - 1 Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Notes: 2 Participants - 1 Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Contact lens intolerance
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: 4 Participants - 2 Cases are OU (oculus uterque)
Frequency: 2 affected / 37 at risk

Adverse event: Ectropion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: 3 Participants - 2 Cases are OU (oculus uterque)
Frequency: 2 affected / 37 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: 14 Participants - 2 Cases are OU (oculus uterque)
Frequency: 2 affected / 37 at risk

Adverse event: Eyelid irritation
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Eyelid margin crusting
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Eyelid pain
Serious: no
Organ System: Eye disorders
Notes: 3 Participants - 2 Cases are OU (oculus uterque)
Frequency: 2 affected / 37 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Notes: 2 Participants - 1 Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Neurotrophic keratopathy
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: 7 Participants - 3 Cases are OU (oculus uterque)
Frequency: 3 affected / 37 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Secretion discharge
Serious: no
Organ System: General disorders
Notes: 2 Participants - 1 Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Notes: 1 Participant - Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Notes: 3 Participants - 1 Case is OU (oculus uterque)
Frequency: 1 affected / 37 at risk

Adverse event: Ulcerative keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Incarcerated parastomal hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Thyroid mass
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 37 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Graft versus host disease
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Tooth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 37 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Benign breast neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 37 at risk

Adverse event: Breast dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 37 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Subgaleal haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Gastrointestinal stoma complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk