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Table 5 Pre-defined adverse events

From: Prophylaxis in healthcare workers during a pandemic: a model for a multi-centre international randomised controlled trial using Bayesian analyses

Symptoms of:

Eye

Blurring of vision

Ear and labyrinth

Hearing loss, tinnitus, vertigo

Gastrointestinal

Abdominal pain, diarrhoea, nausea, vomiting

Immune system

Angioedema, bronchospasm, urticaria

Metabolism

Anorexia, lethargy, weight loss

Musculoskeletal

Muscle weakness

Nervous system

Ataxia, convulsions, dizziness, headache

Psychiatric

Affect lability, nervousness, nightmares, suicidal thoughts

Skin

Alopecia, bleaching of hair, pigmentary changes, pruritus, skin rashes

New diagnosis of:

Blood/Lymphatic

Agranulocytosis, anaemia, bone marrow depression, leucopoenia, thrombocytopenia

Cardiac

Cardiomyopathy, QT interval prolongation

Eye

Corneal changes, extraocular muscle palsies, maculopathies, retinopathy

Hepatobiliary

Abnormal LFTs, fulminant hepatitis

Metabolism

Hypoglycaemia

Musculoskeletal/connective tissue

Absent or hypoactive deep tendon reflexes, neuromyopathy, sensorimotor disorders

Nervous system

Extrapyramidal disorders, nerve deafness, nystagmus

Psychiatric

Psychosis,

Skin

Porphyria, psoriasis

Serious adverse events:

 

Results in death

 

Is life-threatening

 

Requires inpatient hospitalisation or prolongation of existing hospitalisation

 

Results in persistent or significant disability/incapacity

 

Consists of a congenital anomaly or birth defect

 

Other ‘important medical events’ may also be considered serious if they jeopardise the participant or require an intervention to prevent one of the above consequences