Physical Examination Day -1
Physical Examination, Assessment Date
date
Physical Examination, Skin
boolean
Physical Examination, Lung
boolean
Physical Examination, Cardiovascular system
boolean
Physical Examination, Abdomen
boolean
Electronically transferred laboratory data - Clinical Chemistry - Day -1
Laboratory Procedures, Chemistry, Clinical, Relative Time
text
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
date
Laboratory Procedures, Chemistry, Clinical, Time
time
Electronically transferred laboratory data - Haematology - Day -1
Laboratory Procedures, Haematology finding, Relative Time
text
Laboratory Procedures, Haematology finding, Sampling, Date in time
date
Laboratory Procedures, Haematology finding, Time
time
Electronically transferred laboratory data - Urinalysis - Day -1
Laboratory Procedures, Urinalysis, Relative Time
text
Laboratory Procedures, Urinalysis, Sampling, Date in time
date
Laboratory Procedures, Urinalysis, Time
time
Pharmacokinetics - Blood - Day -1
Pharmacokinetic aspects, Blood, Relative Time
text
Pharmacokinetic aspects, Blood, Sampling, Date in time
date
Pharmacokinetic aspects, Blood, Time
time
Pharmacokinetic aspects, Blood, Sample identification number
integer
Vital signs Day 1
Vital Signs Date
date
Vital Signs, Relative time
integer
Vital Signs Time
time
Systolic Pressure, Supine Position
integer
Diastolic blood pressure, Supine Position
integer
Heart rate
integer
Body Temperature, Oral
float
12-Lead-ECG Day 1
12 lead ECG, Electrocardiography, Numbers
integer
12 lead ECG, Start Date
date
12 lead ECG, Relative Time
integer
12 lead ECG, Start Time
time
12 lead ECG, Heart Rate
integer
12 lead ECG, PR Interval
integer
12 lead ECG, QRS Complex Duration
integer
12 Lead ECG, QT interval
integer
For Machine reads QTcB Interval, and/or QTcF can be collected
text
12 lead ECG, QTcB - Bazett's Correction Formula
integer
12 lead ECG, QTcF - Fridericia's Correction Formula
integer
12 lead ECG, Electrocardiogram QT corrected interval
integer
12 lead ECG, Result
integer
12 LEAD ECG Abnormalities Day 1
12 lead ECG, Electrocardiography, Numbers
integer
12 lead ECG, Date in time
date
12 lead ECG, Time
time
12 lead ECG, Abnormality, Electrocardiogram, rhythm
text
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Electrocardiogram QRS complex
text
12 lead ECG, Abnormality, Cardiac conduction
text
12 lead ECG, Abnormality, Myocardial Infarction
text
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality
text
12 Lead ECG, Abnormality, Other
text
Randomisation Number Day 1
Investigational Product Day 1
Experimental Drug
text
Experimental drug, Dosage, Date in time
date
Experimental drug, Dosage, Time
time
Experimental Drug, Medication dose
integer
Experimental drug, Unit of measure
text
Experimental drug, Drug Administration Routes
text
Experimental drug, Pharmaceutical Formulation
text
Treatment Confirmation Day 1
Therapeutic procedure, Correct
boolean
Therapeutic procedure, Incorrect, Reason and justification
text
Pharmacokinetics Blood Day 1
Pharmacokinetic aspects, Blood, Relative Time
text
Pharmacokinetic aspects, Blood, Sampling, Date in time
date
Pharmacokinetic aspects, Blood, Time
time
Pharmacokinetic aspects, Blood, Sample identification number
integer
Pharmacokinetics Blood (Metabolite Samples) Day 1
Pharmacokinetic aspects, Blood, Metabolite, Relative Time
text
Pharmacokinetic aspects, Blood, Metabolite, Sampling, Date in time
date
Pharmacokinetic aspects, Blood, Metabolite, Time
time
Pharmacokinetic aspects, Blood, Metabolite, Sample identification number
integer
Pharmacokinetic Sampling Urine Interval Collection Data Day 1
Pharmacokinetic aspects, Urine, Relative time, Interval
text
Pharmacokinetic aspects, Urine, Start Date
date
Pharmacokinetic aspects, Urine, Start Time
time
Pharmacokinetic aspects, Urine, End Date
date
Pharmacokinetic aspects, Urine, End Time
time
Pharmacokinetic aspects, Urine, Sample weight
float
Pharmacokinetic aspects, Urine, Sample identification number
text
Pharmacokinetic Sampling Faeces Interval Collection Data Day 1
Pharmacokinetic aspects, Faeces, Relative time, Interval
text
Pharmacokinetic aspects, Faeces, Start Date
date
Pharmacokinetic aspects, Faeces, Start Time
time
Pharmacokinetic aspects, Faeces, End Date
date
Pharmacokinetic aspects, Faeces, End Time
time
Pharmacokinetic aspects, Faeces, Sample weight
float
Pharmacokinetic aspects, Faeces, Sample identification number
text
Entero-Test (Day 1, 2 hrs - 6.5 hrs Post-Dose)
Entero string test, Relative time, Interval
integer
Entero string test, Interventional Procedure
text
Entero string test, Start Date
date
Entero string test, Start Time
time
Entero string test, End Time
time