Clinical Laboratory Evaluations Sample Clauses

Clinical Laboratory Evaluations. Clinical laboratory evaluations will be performed by a central laboratory. Prior to starting the study, the Sponsor (or its designee) will provide each Investigator with copies of the appropriate laboratory certifications and normal ranges for all laboratory parameters to be performed by that laboratory. The blood and urinalysis samples are to be obtained under fasting conditions (NPO for 8 hours; water is acceptable) in the morning of each scheduled study visits on Day 1 and Months 6, 12, 18, and 24. All clinically significant laboratory abnormities indicating an adverse event will be followed up by repeat testing and further investigated as necessary, according to the judgment of the Investigator.

Clinical Laboratory Evaluations. The clinical laboratory evaluations will be collected at Screening and on Day 1 of each cycle, and will include a complete set of clinical labs, including serum chemistry, complete blood count with differential, and urinalysis, as described in §6.2.

Clinical Laboratory Evaluations. Clinical laboratory (hematology and chemistry) and urinalysis will be performed according to the Schedule of Events (see Appendix 14.1). Females of childbearing potential will provide a serum sample for a pregnancy testing during Screening at each study visit. Clinical safety laboratory tests will be performed by a central laboratory. For patient safety, clinical laboratory samples to manage patient adverse events may be analyzed using the clinic’s local laboratory. Table 9 summarizes tests that will be performed. The Investigator will monitor the laboratory test findings. If any laboratory test on or after the first study drug treatment is abnormal, it will be followed at the discretion of the Investigator. Abnormal laboratory tests, including ECGs, may, in the opinion of the Investigator, be considered clinically significant and, thus, constitute or be associated with an AE. In such cases, they must be reported on the AE page of the CRF. Any abnormal clinical lab that is determined not to be clinically significant will have a description of the reason for this determination documented on the lab CRF. Table 9: Clinical Laboratory Tests Hematology Serum Chemistry Urinalysis Hematocrit Alanine aminotransferase Bilirubin Hemoglobin Albumin Blood (qualitative) Mean corpuscular hemoglobin Aspartate aminotransferase Color Mean corpuscular hemoglobin concentration Alkaline phosphatase Glucose Mean corpuscular volume Amylase Ketones Erythrocytes Conjugated bilirubin Leukocyte esterase Red cell distribution width Total bilirubin Nitrite Platelet count Blood urea nitrogen pH Leukocytes Calcium Protein Differential (absolute, %) Bicarbonate Specific gravity Basophils Chloride Turbidity Eosinophils Total cholesterol Urobilinogen Lymphocytes Creatinine Microscopic examination Monocytes Gamma glutamyl transpeptidase Neutrophils Glucose Reticulocyte count Lactate dehydrogenase Phosphorus Potassium Total protein Sodium Triglycerides Uric acid Other Laboratory Tests Serum pregnancy test Human chorionic gonadotropin as applicable

Clinical Laboratory Evaluations. The following routine clinical laboratory tests will be collected at the time points specified in Section 2 and analyzed by an accredited central laboratory selected by the Sponsor and prepared according to the Laboratory Manual provided for the study: Chemistry: Sodium, chloride, potassium, calcium, glucose, creatinine, blood urea nitrogen (BUN), albumin, uric acid, total bilirubin, alkaline phosphatase, amylase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), lactase dehydrogenase (LDH), C-reactive protein (CRP), creatine kinase (CK), and serum cystatin C Hematology: Red blood cells (RBCs), total white blood cells (WBCs), hemoglobin, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, and abnormal cells Coagulation Screen: Prothrombin time, International Normalized Ratio (INR), and activated partial thromboplastin time (aPTT) Urinalysis: pH, specific gravity, protein, glucose, ketones, cytology, hemoglobin, and kidney injury molecule-1 (XXX-1) Any value outside of the current reference ranges for the laboratory performing the test will be flagged on the laboratory results. The Investigator will determine whether abnormal assessment results are clinically significant (CS) or not clinically significant (NCS). Clinical significance is defined as any variation in assessment results that has medical relevance resulting in an alteration in medical care. If clinically significant deterioration from baseline levels is noted, the Investigator will continue to monitor the patient with additional assessments until: • Values have reached normal range and/or baseline levels; or • In the judgment of the Investigator together with the Sponsor’s Medical Monitor, abnormal values assessed to be not related to the administration of investigational product or other protocol-specific procedures, and additional assessments are not medically indicated.