Dose intensity. Dose intensity of AZD5363 and paclitaxel will be addressed by considering relative dose intensity (RDI) defined as follows: RDI = 100% * d/D where d is the actual cumulative dose delivered up to the earlier of progression (or a censoring event) or the actual last day of dosing and D is the intended cumulative dose up to the earlier of progression (or a censoring event) or the actual last day of dosing plus the protocol-defined post-dose rest period. If there is no progression and a patient had no evaluable assessments then to calculate RDI for AZD5363, the patient will be censored at day 2 (i.e. the first day of AZD5363 dosing) and for calculating RDI for paclitaxel, the patient will be censored at day 1. RDI for AZD5363 and paclitaxel will be calculated for the entire intended treatment period.
Dose intensity. Dose intensity of AZD5363 and paclitaxel will be addressed by considering relative dose intensity (RDI) and Percent intended dose (PID), defined as follows: RDI = 100% * d/D where d is the actual cumulative dose delivered up to the earlier of progression (or a censoring event) or the actual last day of dosing and D is the intended cumulative dose up to the earlier of progression (or a censoring event) or the actual last day of dosing plus the protocol-defined post-dose rest period. PID = 100% * d1/D1 Where d1 is the actual cumulative dose delivered up to progression (or a censoring event) and D1 is the intended cumulative dose up to progression (or a censoring event). D1 is the total dose that would be delivered, if there were no modifications to dose or schedule. RDI and PID for AZD5363 and paclitaxel will be calculated for the entire intended treatment period (censored at data cut-off).
