Vital Signs
Time from last dose of investigational product until Vital Signs measurement
integer
Cohort 1-4 SD Day-1: at 2h and 3h in standing position
integer
Actual date of vital signs
date
Actual time of vital signs
time
Systolic Blood Pressure
integer
Diastolic Blood Pressure
integer
Heart rate
integer
Respiration rate
integer
Temperature
float
ECG
Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) Cohort 1-4 RD Day-14, 21: 12-lead-ECG, Holter (0-48hrs), Telemetry (0-6hrs)
integer
Time from last dose of investigational product until ECG
integer
Start Date ECG
date
Start Time ECG
time
Stop Date ECG
date
Stop Time ECG
time
Duration of ECG recording
integer
Haematology
Haematology sampling date and time
datetime
Fasting
boolean
Please answer the following questions for each Haematology Analyte
integer
Type of result
integer
Haematology Numeric Result
float
Haematology Character Result
text
Clinical Chemistry
Date and time sample taken
datetime
Fasting
boolean
Please answer the following questions for each Clinical Chemistry Analyte
integer
Type of result
integer
Clinical Chemistry Numeric Result
float
Clinical Chemistry Character Result
text
Urinalysis - Local
Date sample taken
date
Time sample taken
time
Result of dipstick
integer
If Yes, provide details of repeated tests in the add entry section below
boolean
Urinalysis - Local: Dipstick Details
Please answer the following questions for each Urinalysis Analyte
integer
Type of result
integer
Urinalysis Numeric Result
float
Urinalysis Character Result
text
Urinalysis - Local: Microscopy Details
Please answer the following questions for each Urinalysis Analyte
integer
Type of result
integer
Urinalysis Numeric Result
float
Urinalysis Character Result
text
Pharmacokinetics Urine
Pharmacokinetics Urine Start Date
date
Pharmacokinetics Urine Start Time
time
Pharmacokinetics Urine Stop Date
date
Pharmacokinetics Urine Stop Time
time
Total sample volume
float
Total sample weight
float
Sample pH
float
Local Laboratory - Clinical Chemistry Hormones 1
Date and time sample taken
datetime
Fasting
boolean
Please answer the following questions for each Clinical Chemistry Analyte
integer
Type of result
integer
Clinical Chemistry Numeric Result
float
Clinical Chemistry Character Result
text
Local Laboratory - Clinical Chemistry Hormones 2
Date and time sample taken
datetime
Time from last dose of investigational product until Hormones 2 measurement
integer
Fasting
boolean
Please answer the following questions for each Clinical Chemistry Analyte
integer
Type of result
integer
Clinical Chemistry Numeric Result
float
Clinical Chemistry Character Result
text
Local Laboratory - Clinical Chemistry Hormones 3
Laboratory ID
text
Date and time sample taken
datetime
Time from last dose of investigational product until Hormones 3 measurement
integer
Fasting
boolean
Please answer the following questions for each Clinical Chemistry Analyte
integer
Type of result
integer
Clinical Chemistry Numeric Result
float
Clinical Chemistry Character Result
text
Questionnaires
Investigational Product
Pharmacokinetics Blood
Time from last dose of investigational product until Clinical Chemistry measurement
integer
Actual Time of Pharmacokinetics Blood
time
Meal
Start date Meal
date
Start time meal
time
Type of Meal
text
Percentage of Meal Consumed
float