Laboratory Tests-Hematology
Screening, Day 1, Day 2.... If the laboratory changes during the study, a new set of reference ranges must be completed.
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Sample Date
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Sample Time
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Hemoglobin
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Hematocrit
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RBC
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WBC
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Neutrophils - segmented
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Bands
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Lymphocytes
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Monocytes
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Eosinophils
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Basophils
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Platelets
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Blast Cells
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Prothrombin Time (PT)
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Partial Thromboplastin Time
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Fibrinogen
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Laboratory Tests-Blood Chemistry
Screening, Day 1, Day 2.... Day 1 tests are required only if not performed within the previous 7 days or if abnormal at the Screening visit. Do not fill day 1 if not required NOTE: If the laboratory changes during the study, a new set of reference ranges must be completed.
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Sample Date
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Sample Time
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Sodium
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Potassium
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Chloride
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Bicarbonate
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Calcium
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Phosphorus
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Magnesium
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BUN
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Urea
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Uric Asid
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Creatinine
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Alkaline Phosphatase
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LDH
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SGOT/AST
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SGPT/ALT
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Total Bilirubin
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Direct Bilirubin
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Total Protein
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Albumin
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Creatinine Clearance
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Serum Beta HCG
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Are there clinically significant abnormal laboratory values?
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Laboratory Tests-Urinalysis
Screening, Day 1, Day 2....
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Sample Date
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Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
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Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
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Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
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Complete microscopy if protein and/or blood results are positive Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
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Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
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Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
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Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
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Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
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If 'Yes', record the findings and/or diagnosis on page x for Screening, or in the Adverse Experience section
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Laboratory Tests-Bone Marrow Examination
Screening, visit 1...
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Sample Date
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Erythroid Series
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Erythroid Series
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Erythroid Series
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Erythroid Series
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Neutrophils (%)
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Eosinophils (%)
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Basophils (%)
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Bands (%)
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Metamyelocytes (%)
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Myelocytes (%)
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Promyelocytes (%)
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Myeloblasts (%)
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Lymphocytes (%)
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Plasma Cells (%)
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Monocytes (%)
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Reticulum Cells (%)
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Megakaryocytes (%)
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Myeloid Erythroid Ratio
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Cellularity of Specimen
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Biopsy
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Splenomegaly
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Extramedullary disease or soft tissue involvement
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If yes to Extramedullary disease or soft tissue involvement
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Cytogenetics
Screening, Visit-1 ...
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Sample Date
date
Chromosome Abnormalities Present
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