Vital Sign Measurements. Vital sign measurements include the patient’s heart rate (beats/minute taken for at least 15 seconds), respiration rate, and body temperature. Blood pressure should be taken after the patient has rested in a sitting position for at least 5 minutes. The same arm (usually the non- dominant arm) and the appropriate size cuff should be used for each measurement. Vital sign measurements should be taken as indicated in Table 3.
Vital Sign Measurements. Vital signs will be measured after the subject has been in the seated position for at least 5 minutes. A repeat measurement of vital sign measurements is permitted for eligibility determination. On Day 1, vital signs will be measured before study drug administration and before any scheduled blood collections (Section 3). Subsequent measurements of vital signs (once a day on Days 2-6) may occur anytime during the day, either in the clinic or with mobile nursing staff. Vital signs will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. In addition, temperature will be measured orally at least every 4 hours during the study treatment period (morning, mid day, late afternoon, evening, while the subject is awake) and will be recorded in a patient diary.
Vital Sign Measurements. Xxxxx xxxxx will be measured after the subject has been seated for at least 5 minutes at the time points indicated in the schedule of events (Table 9-1). Vital sign measurements will include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. When procedures are overlapping and occurring at the same time point, the order of procedures should be ECG, vital sign measurements, and then blood collection, with the blood collection scheduled to occur at the nominal time point, unless dictated by other study events happening at that time, such as dosing requirements. The investigator will determine whether any of the vital sign measurements are clinically significant or not clinically significant. Clinical significance is defined as any variation in results that has medical relevance and may result in an alteration in medical care (eg, active observation, diagnostic measures, or therapeutic measures). If a clinically significant change from the screening values is noted, the clinically significant value and reason for clinical significance will be documented on the AE page of the subject’s eCRF. The investigator will continue to monitor the subject with additional assessments until the value has reached the reference range or the value at screening or until the investigator determines that follow up is no longer medically necessary.
Vital Sign Measurements. All vital signs will be measured after the subject has been in the seated position for at least 5 minutes. Vital signs will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Vital signs will be measured at screening and check-in; prior to aramchol dosing; 4, 12, and 24 hours after dosing; Days 3 and 4; prior to discharge on Day 8 (healthy subjects) or Day 11 (hepatically impaired subjects); and at EOS. Vital signs will be measured at screening and check-in, prior to the AM aramchol dosing on Day 1; 4 hours after the AM dose on Days 1 through 12; prior to discharge on Day 13; and at EOS.
