9.2. Clinical Laboratory Evaluations T he following laboratory parameters will be summarized: •S erum Chemistry - alanine aminotransferase (ALT) , alkaline phosphatase (ALP) , aspartate aminotransferase (AST) , bicarbonate, blood urea nitrogen (BUN), calcium , chloride, creatinine , glucose , lactate dehydrogenase (LDH), potassium, sodium, testosterone , and total bilirubin . •Hematology - basophils, eosinophils, hematocrit (HCT), hemoglobin (HGB), lymphocytes, monocytes , neutrophils , platelets , red blood cells (RBC) and white blood cells (WBC) . •Urinalysis - protein , glucose, ketones, blood, leukocyte e sterase , specific gravity , and pH •Coagulation - PT, PTT, INR Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential 20 Revised: June 2015 •Virology – HIV Viral Load, Hepatitis B Surface Antigen (HBSAG), Hepatitis C Viral Load (HCV) •Additional - Prostate Specific Antigen (PSA), Prostatic Acid Phosphatase (PAP), C - Reactive Protein (CRP) C hange from baseline tables will be presented for laboratory tests with numeric results. Mean change from baseline to each scheduled post -baseline visit, last visit with available assessment, and minimum and maximum post- baseline assessments will be presented for each test. Shift from baseline tables by CTCAE v 4.0 (or higher) grades (where applicable) and by high/low flags (where CTCAE grades are not defined) will be presented to show the number and percentage of subject s in each cell . All scheduled post- baseline visits, last visit with available assessment, and worst shift overall will be included in shift tables. Laboratory tests ( calcium, glucose and sodium) that have both high and low abnormalities will be summarized separately by CTCAE v4.0 (or higher) grades for each direction of abnormality (e.g. hypercalcemia vs.