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 |