DEFINITION OF ANALYSIS SETS Sample Clauses

DEFINITION OF ANALYSIS SETS. The analysis of data will be based on different subsets of overall patient population according to the purpose of analysis. Five analysis populations are defined for this study: Safety analysis set, DLT analysis set, PK analysis set, Full analysis set and Pharamacodynamic analysis set as defined in the table below (Table 1). Analysis Set Definition Safety analysis set All patients who received at least 1 dose of AZD5363. DLT analysis set All patients who either completed the DLT evaluation period with sufficient dosing (at least 80% of specified dose of AZD5363 or paclitaxel during the DLT evaluation period), or who experienced a DLT during that period. PK analysis set Dosed patients for whom concentration time data/PK profile data for AZD5363 or paclitaxel has been obtained. Full analysis set All patients who received at least 1 dose of AZD5363. Pharmacodynamic analysis set All patients dosed with AZD5363 that provided biological samples for pharmacodynamic research.
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