Table 2

Clinical laboratory assessments

Clinical chemistry
Renal functionUrea, Creatinine*
Liver function test panelAlbumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase and bilirubin (total)†
Electrolytes and othersCalcium, potassium, sodium, magnesium, inorganic phosphate, glucose and lactate dehydrogenase
HaematologyHaematocrit, haemoglobin, white cell count, red blood cell count, neutrophils and platelets
Coagulation testsActivated partial thromboplastin and international normalisation ratio‡
Urinalysis for proteinuriaUPC§
Thyroid function testThyroid-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).