SAFETY ASSESSMENTS AND ENDPOINTS. Safety and tolerability will be assessed by monitoring and recording of AEs, clinical laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature), 12-lead ECG results, and physical examination findings. Adverse events will be assessed from the time of the first dose of study drug until the follow-up telephone call on Day 37 (+2 days).
SAFETY ASSESSMENTS AND ENDPOINTS. Safety and tolerability will be assessed by the following endpoints: monitoring and recording of AEs, clinical laboratory test results (hematology, coagulation, serum chemistry, and urinalysis), vital sign measurements, 12-lead ECG results, and physical examination findings.
SAFETY ASSESSMENTS AND ENDPOINTS. Safety and tolerability will be assessed by the following endpoints: monitoring and recording of AEs, clinical laboratory test results (hematology, coagulation, serum chemistry, and urinalysis), vital sign measurements, 12-lead ECG results, and physical examination findings. For all safety assessments, the investigator will determine whether results are clinically significant, which is defined as any variation in a result that has medical relevance and may result in an alteration in medical care (eg, active observation, diagnostic measures, or therapeutic measures). If clinical significance is noted, the result and reason for significance will be documented and an AE reported on the AE page in the subject’s eCRF. The investigator will monitor the subject until the result has reached the reference range or the result at screening, or until the investigator determines that follow-up is no longer medically necessary.
