Dosing Date and Time
Vital Signs
Only applicable on Day 1 (identical for all Parts/Cohorts/Subcohorts). Fill in the entire repeating itemgroup once per Vital Sign assessment on this day.
integer
At Screening, record Vital Signs three times (Measurements 1 to 3). Fill in for repeat Vital Signs if necessary. Fill in the entire repeating itemgroup once per Vital Sign assessment. At Screening, Measurement 1 (of 3), fill in all items. At the two other Screening Measurements, record time, blood pressure, heart rate and respiratory rate.
integer
Date/time
datetime
Height
integer
Weight
float
calculated from height and weight
float
Blood pressure systolic
integer
Blood pressure diastolic
integer
Heart Rate
integer
Body Temperature
float
Respiration rate
integer