Table 4 Adverse events defined using MedDRA Preferred Terms. The bolded MedDRA Preferred Term is used to name the adverse event, while all MedDRA Preferred Terms grouped together were used to define that adverse event

ACCIDENT

CONFUSIONAL STATE

HALLUCINATION

PULMONARY OEDEMA

ACUTE KIDNEY INJURY

CONJUNCTIVITIS

HEPATIC FAILURE

RECTAL HAEMORRHAGE

AGGRESSION

CROHN’S DISEASE

HEPATIC NECROSIS

RENAL FAILURE

AGRANULOCYTOSIS

DEAFNESS

HEPATITIS

RENAL IMPAIRMENT

AMNESIA

DEEP VEIN THROMBOSIS

HOSTILITY

RESPIRATORY DEPRESSION

ANAEMIA

DELIRIUM

HYPERSENSITIVITY

RHABDOMYOLYSIS

ANAPHYLACTOID REACTION

DELUSION

HYPERTENSION

ROAD TRAFFIC ACCIDENT

ANGINA PECTORIS

DERMATITIS BULLOUS

HYPOGLYCAEMIA

SEROTONIN SYNDROME

ANGIOEDEMA

DERMATITIS EXFOLIATIVE

ABASIA

SKIN ULCER

APLASTIC ANAEMIA

DIABETES MELLITUS

IMPAIRED HEALING

SLEEP DISORDER

APNOEA

DIPLOPIA

INFECTION

STOMATITIS

ARRHYTHMIA

DISORIENTATION

INJURY

SUDDEN DEATH

ATRIOVENTRICULAR BLOCK

DYSGEUSIA

INSOMNIA

TACHYCARDIA

AZOTAEMIA

EMBOLISM

INTERSTITIAL LUNG DISEASE

THROMBOCYTOPENIA

BACTERIAL INFECTION

EOSINOPHILIA

LARYNGEAL OEDEMA

THROMBOPHLEBITIS

BLINDNESS

ERYTHEMA MULTIFORME

LEUKOPENIA

THROMBOSIS

BONE MARROW FAILURE

COLITIS ULCERATIVE

MEMORY IMPAIRMENT

TINNITUS

BRADYCARDIA

FALL

MYOPATHY

TOXIC EPIDERMAL NECROLYSIS

BRONCHITIS

FEBRILE NEUTROPENIA

MYOSITIS

ULCER

CANDIDA INFECTION

FRACTURE

NEUTROPENIA

VISION BLURRED

CARDIAC ARREST

FUNGAL INFECTION

OLIGURIA

URINARY TRACT INFECTION

CARDIOMYOPATHY

GLAUCOMA

PANCYTOPENIA

URTICARIA

CATARACT

GRANULOCYTOPENIA

PARALYSIS

VAGINAL HAEMORRHAGE

CELLULITIS

HAEMATOMA

PARANOIA

VASCULITIS

GASTROINTESTINAL HAEMORRHAGE

NEUROLEPTIC MALIGNANT SYNDROME

PHOTOSENSITIVITY REACTION

UPPER RESPIRATORY TRACT INFECTION

CHOLESTASIS

HAEMOLYTIC ANAEMIA

PNEUMONIA

WEIGHT INCREASED

COAGULOPATHY

HAEMORRHAGE

PROTEINURIA

SEIZURE, EPILEPSY

COLITIS

CEREBRAL INFARCTION

PULMONARY EMBOLISM

SEPSIS, SEPTIC SHOCK

STEVENS-JOHNSON SYNDROME

EXTRAPYRAMIDAL DISORDER

JAUNDICE, JAUNDICE CHOLESTATIC

RESPIRATORY ARREST, RESPIRATORY FAILURE

ANAPHYLACTIC REACTION, ANAPHYLACTIC SHOCK

NEUROPATHY PERIPHERAL, PARAESTHESIA

HYPERGLYCAEMIA, BLOOD GLUCOSE INCREASED

OEDEMA PERIPHERAL, OEDEMA

CARDIAC FAILURE CONGESTIVE, CARDIAC FAILURE

TORSADE DE POINTES, ELECTROCARDIOGRAM QT PROLONGED

MYOCARDIAL INFARCTION, ACUTE MYOCARDIAL INFARCTION

ATRIAL FIBRILLATION, SUPRAVENTRICULAR TACHYCARDIA

CEREBRAL HAEMORRHAGE, HAEMORRHAGE INTRACRANIAL, CEREBELLAR HAEMORRHAGE

SUICIDAL BEHAVIOUR, COMPLETED SUICIDE, SUICIDE ATTEMPT, SUICIDAL IDEATION

VENTRICULAR FIBRILLATION, VENTRICULAR ARRHYTHMIA, VENTRICULAR EXTRASYSTOLES, VENTRICULAR TACHYCARDIA

HYPERKINESIA, TARDIVE DYSKINESIA, DYSKINESIA, AKATHISIA, DYSTONIA, HYPERTONIA

HYPERCHOLESTEROLAEMIA, HYPERLIPIDAEMIA

HEPATOTOXICITY, LIVER INJURY

PANCREATITIS, PANCREATITIS ACUTE

GASTRIC ULCER, PEPTIC ULCER

CEREBROVASCULAR ACCIDENT, TRANSIENT ISCHAEMIC ATTACK

VISUAL ACUITY REDUCED, VISUAL IMPAIRMENT, VISUAL FIELD DEFECT

DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS