Clinical Laboratory Tests. The Company’s clinical laboratory tests are conducted in compliance in all material respects with all applicable Health Care Laws, and, to the extent applicable, the respective counterparts thereof promulgated by governmental authorities in countries outside the United States. The Company has not received notice from the FDA, HHS or other governmental authority alleging or asserting material noncompliance with any applicable Health Care Law. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.
Clinical Laboratory Tests. The manufacture of the Company’s clinical laboratory tests and equipment by or on behalf of the Company or its subsidiaries is being conducted in compliance in all material respects with all applicable Health Care Laws, and, to the extent applicable, the respective counterparts thereof promulgated by governmental authorities in countries outside the United States. The Company has not had any laboratory test, clinical laboratory or manufacturing site and, to the Company’s knowledge, that any of its third-party manufacturers, subject to a governmental authority (including United States Food and Drug Administration (the “FDA”)) shutdown or import or export prohibition, nor received any FDA Form 483 or other governmental authority notice of inspectional observations or deficiencies, “warning letters,” “untitled letters,” requests to make changes to the Company’s clinical laboratory tests, processes or operations, or similar correspondence or notice from the FDA or other governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.
Clinical Laboratory Tests. A summary of observed values and change from baseline will be presented for all laboratory parameters with numerical measures using descriptive statistics. Shift tables displaying low- normal-high at baseline versus low-normal-high at end of study in a 3-by-3 contingency table will be provided. For selected laboratory parameters, scatter plots of baseline versus Week 56 results, will be produced by treatment group. A laboratory value that is above or below normal range will be considered an abnormal value. For selected laboratory parameters, threshold limits of clinical concern will be defined as multiplicative factors of the normal ranges. The list of multiplicative factors for each laboratory parameter will be included in the Statistical Analysis Plan. The frequency and percentage of subjects with laboratory results above or below the normal range and threshold limits at each scheduled assessment or any time during the treatment will be summarized by treatment group.
Clinical Laboratory Tests. Blood and urine samples will be collected as indicated in the schedule of assessments in Table 4 and Table 5, for the evaluation of haematology, serum chemistry, laboratory urinalysis/microscopy, urine culture and sensitivity, and anti BTX-A antibodies. Analysis will be performed by central laboratories. Full details regarding clinical laboratory tests are contained in the study central laboratory manual and trial master file. The investigator will review the laboratory urinalysis/microscopy, urine culture and sensitivity, haematology, and serum chemistry laboratory results; document the review, and record any clinically relevant changes occurring or observed during the study in the AE section of the eCRF (see Section 8.1.2.4 for abnormal laboratory tests that should be recorded as AEs, and Section 8.2.3 regarding specific information related to laboratory urinalysis/microscopy). All clinically relevant abnormal laboratory tests occurring during the study will be repeated at appropriate intervals until they return to Baseline or to a level deemed acceptable by the investigator and the sponsor’s clinical monitor (or his/her designated representative) or until the abnormality is explained by an appropriate diagnosis (see Section 8.2.3 for specific details regarding laboratory urinalysis/microscopy abnormalities).
Clinical Laboratory Tests. Table 19 presents the clinical laboratory tests that will be performed during the study. Table 19: Clinical Laboratory Tests (Parts A, B, and C Unless Indicated) Hemoglobin Hematocrit Mean corpuscular volume Mean corpuscular hemoglobin Mean corpuscular hemoglobin concentration WBC count WBC differential1 (Parts A and B Only) RBC count Lymphocytes Monocytes Neutrophils Band neutrophils (Parts A and B Only) Eosinophils Basophils Platelets Reticulocyte count Sodium Potassium Chloride Bicarbonate Blood urea nitrogen Creatinine Glucose Calcium Phosphate Magnesium ALT AST Alkaline Phosphatase Total bilirubin2 Lactate dehydrogenase Total protein Albumin Amylase3 Lipase3 Creatinine kinase Urate Thyroid-stimulating hormone3 Prothrombin time (Parts A and B Only) International normalization ratio (Parts A and B Only) Activated thromboplastin time (Parts A and B Only) Urinalysis4 Appearance (Parts A and B Only) Color (Parts A and B Only) Urine bilirubin (Parts A and B Only) Glucose (Parts A and B Only) Hemoglobin (Parts A and B Only) Ketones (Parts A and B Only) pH (Parts A and B Only) Protein (Parts A and B Only) Specific gravity (Parts A and B Only) Urobilinogen (Parts A and B Only) Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; RBC = red blood cell; ULN: upper limit of normal; WBC = white blood cell.
1 WBC differential may be automated or manual as per institutional standards. Blasts should be included.
2 If the total bilirubin concentration is increased > 1.5 × ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. 3 If not included in the complete serum chemistry panel at the site, amylase, lipase, and TSH must be performed at the time points indicated in Table 1, Table 2, and Table 3 for Parts A and B and Table 5, Table 6, and Table 7 for Part C. 4 Microscopy will only be performed if clinically indicated at the discretion of the Investigator. Urinalysis is only required for Parts A and B. All laboratory safety assessments will be performed and analyzed at each site by a certified local laboratory. The Investigator or designee will review the laboratory results and assess the clinical significance of all abnormal values. Appropriate action will be taken for any clinically significant abnormal values. Values will be documented on the laboratory report until stabilized, or the laboratory value returns to a clinically acceptable range (regardless of relationship to study treatment) or bas...
Clinical Laboratory Tests. A summary of observed values and change from baseline will be presented for all laboratory parameters with numerical measures. For selected laboratory parameters, scatter plots of baseline versus week 56 results, will be produced by treatment group. A laboratory value that is above or below normal range will be considered an abnormal value. For selected laboratory parameters, threshold limits of clinical concern will be defined as multiplicative factors of the normal ranges. The list of multiplicative factors for each laboratory parameter will be included in the Statistical Analysis Plan. The frequency and percentage of subjects with laboratory results above or below the normal range and threshold limits at each scheduled assessment or any time during the treatment will be summarized by treatment group.
Clinical Laboratory Tests. All clinical laboratory test results outside of the reference range will be interpreted by the investigator using the following categories: • abnormal but not a clinically significant worsening • abnormal and a clinically significant worsening
Clinical Laboratory Tests. Clinical chemistry, hematology, coagulation, and urinalysis will be presented by treatment condition and visit, summarizing the actual values and change from Baseline to each visit for each parameter using descriptive statistics for each continuous, and frequency tables for each discrete parameter. Frequency tables of predefined change abnormal of select laboratory parameter values will be generated.
Clinical Laboratory Tests. Clinical laboratory data will be listed for each subject. Values outside the normal laboratory reference ranges will be flagged as high or low on the listings.
Clinical Laboratory Tests. Refer to the Laboratory Manual for details regarding clinical efficacy/pharmacodynamic laboratory sample collection, processing, storage, and shipment. Note that in Cohort 3 (75 mg), some of the exploratory biomarker samples will not be collected or may be collected on an optional basis, as indicated in Table 2.
