Table 1.

Definition of adverse reactions

Adverse reaction	Definition of specific adverse reaction
Nausea and vomiting	Documentation of nausea/vomiting by physician
Diarrhoea	Documentation of diarrhoea by physician
Depression	As diagnosed by a TB physician and/or as judged by a psychiatrist, based on ICD-10 criteria
Psychosis	As diagnosed by a TB physician and/or as judged by a psychiatrist, based on ICD-10 criteria
Seizure	Witnessed or unwitnessed event consistent with seizure, e.g., tonic-clinic movement, bowel-bladder incontinence, post-ictal confusion, etc.
Ototoxicity	Hearing loss confirmed by physical examination or audiometry
Arthralgia	Joint pain as reported by patient and documented by physician, with or without presence of arthritis
Rash	Dermatological reaction felt to be related to anti-tuberculosis medicines, as documented by the physician
Neuropathy	Symptoms and findings consistent with neuropathy, e.g., pain or numbness of distal extremities, as diagnosed by physician or electromyography
Nephrotoxicity	Elevation of at least one creatinine value >141 mmol/l
Hepatotoxicity	Elevation of either serum transaminase or serum bilirubin at least 3 times ULN (AST/ALT ULN 0.45 or 0.68 mmol/l, depending on technique; bilirubin ULN 20.5 mmol/l)
Hypokalaemia	At least one serum potassium value of <3 mEq/l
Hypothyroidism	At least one measure of TSH >10.0 IU/ml

TB = tuberculosis; ICD = International Classification of Diseases; AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal; TSH = thyroid-stimulating hormone.