Laboratory variables Sample Clauses

Laboratory variables. Blood and urine samples for determination of haematology, clinical chemistry, and urinalysis will be collected as outlined in CSP section 6.4.5. Laboratory values will be graded according to CTCAE version 4.0. Neutrophils and glucose values with a grade >= 4 will be used to determine tolerability for the go-no go criteria. The baseline value of each laboratory variable will be derived, as described in the Clinical Study Protocol; values captured up to 3 days before baseline visit will be considered suitable for a baseline value. If multiple records are present between -3 days and baseline visit (cycle 1 day 1) then the last value obtained prior to the first dose of study medication will be considered as baseline. Alternatively, if two visits are equally eligible to assess patient status at baseline (e.g., screening and baseline assessments both prior to first dose with no washout or other intervention in the screening period), the average can be taken as a baseline value. The post-baseline non-missing values of laboratory parameter closest to the scheduled visit date will be considered as the visit value. If two assessments are equidistant from a scheduled visit, then the earlier of the two will be used. The visit will be missing if no assessment was reported within the specified visit window around the scheduled date. Designation of visits for Lab data assessment are given in table below (Table 7): Table 7 Day Ranges for lab assessments Cycle No. Visit day Target day Day Range Screening -1 -28 – -1 1 Day 1 (Baseline) 1 -3 – 1 (prior to dose)

Laboratory variables. These laboratory variables are recorded as positive if keywords are present in the medical record or progress note. (Data abstracted directly from laboratory reports is described in a later section.)