In addition, we describe the development of an integrated PK/PD modelling approach to characterise the temporal dose–response relationships of drug action on platelets and serum growth differentiation factor-15 (GDF-15) as a downstream marker of p53 pathway activation; predict platelet response and incidence rates of thrombocytopenia; and identify associations between GDF-15 induction and risk of developing delayed thrombocytopenia. This evidence concerns the gene TP53 and Thrombocytopenia.