Clinical laboratory assessments
| Clinical chemistry | |
|---|---|
| Renal function | Urea, Creatinine* |
| Liver function test panel | Albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase and bilirubin (total)† |
| Electrolytes and others | Calcium, potassium, sodium, magnesium, inorganic phosphate, glucose and lactate dehydrogenase |
| Haematology | Haematocrit, haemoglobin, white cell count, red blood cell count, neutrophils and platelets |
| Coagulation tests | Activated partial thromboplastin and international normalisation ratio‡ |
| Urinalysis for proteinuria | UPC§ |
| Thyroid function test | Thyroid-stimulating hormone¶ |
*Estimated creatinine clearance should be calculated using the Cockroft and Gault method. Alternatively, creatinine clearance can be measured directly by 24 h urine collection.
†A direct bilirubin level should be obtained if the total bilirubin level is >1.5×upper limit of normal. See online supplementary material for stopping criteria and dose modification guidelines for treatment-emergent liver function abnormality.
‡Coagulation tests may also be performed in response to an adverse event/sever adverse event of bleeding and as clinically indicated.
§UPC should be evaluated based on the ratio of protein concentration to creatinine concentration in a random urine sample or by 24 h urine protein. If UPC ≥3 or if urine protein is ≥3 g, then the dose modification guidelines should be followed.
¶Unscheduled thyroid function tests (thyroid-stimulating hormone and thyroxine (free T4)) should be performed if clinically indicated (eg, if a participant develops signs and symptoms suggestive of hypothyroidism).