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
date
Sample Time
time
Hemoglobin
float
Hematocrit
float
RBC
float
WBC
text
Neutrophils - segmented
float
Bands
float
Lymphocytes
float
Monocytes
float
Eosinophils
float
Basophils
float
Platelets
float
Blast Cells
float
Prothrombin Time (PT)
float
Partial Thromboplastin Time
float
Fibrinogen
float
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
date
Sample Time
time
Sodium
float
Potassium
float
Chloride
float
Bicarbonate
float
Calcium
float
Phosphorus
float
Magnesium
float
BUN
float
Urea
float
Uric Asid
float
Creatinine
float
Alkaline Phosphatase
float
LDH
float
SGOT/AST
float
SGPT/ALT
float
Total Bilirubin
float
Direct Bilirubin
float
Total Protein
float
Albumin
float
Creatinine Clearance
float
Serum Beta HCG
float
Are there clinically significant abnormal laboratory values?
text
Laboratory Tests-Urinalysis
Screening, Day 1, Day 2....
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Sample Date
date
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
float
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
float
Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
float
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.
boolean
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
float
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
float
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
float
Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.
text
If 'Yes', record the findings and/or diagnosis on page x for Screening, or in the Adverse Experience section
boolean
Laboratory Tests-Bone Marrow Examination
Screening, visit 1...
text
Sample Date
date
Erythroid Series
float
Erythroid Series
float
Erythroid Series
float
Erythroid Series
float
Neutrophils
float
Eosinophils
float
Basophils
float
Bands
float
Metamyelocytes
float
Myelocytes
float
Promyelocytes
float
Myeloblasts
float
Lymphocytes
float
Plasma Cells
float
Monocytes
float
Reticulum Cells
float
Megakaryocytes
float
Myeloid Erythroid Ratio
float
Cellularity of Specimen
text
Biopsy
text
Splenomegaly
boolean
Extramedullary disease or soft tissue involvement
boolean
If yes to Extramedullary disease or soft tissue involvement
text
Cytogenetics
Screening, Visit-1 ...
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Sample Date
date
Chromosome Abnormalities Present
text