Local Laboratory - Haematology (Period 1)
Date and time sample taken (Haematology)
datetime
Has the subject fasted? (Haematology)
boolean
Local Laboratory - Haematology (Period 1)
Haematologic test
integer
Numeric result (Haemoatology)
float
Character result (Haematology)
text
No result (Haematology)
integer
Local Laboratory - Clinical Chemistry (Period 1)
Date and time sample taken (Clinical Chemistry)
datetime
Has the subject fasted? (Clinical Chemistry)
boolean
Local Laboratory - Clinical Chemistry (Period 1)
Clinical Chemistry Test
integer
Numeric result (Clinical Chemistry)
float
Character result (Clinical Chemistry)
text
No result (Clinical Chemistry)
integer
Investigational Product (Dose) (Period 1)
Date/time of dose
datetime
Number of Inhalations
integer
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
If subject did not recieve the correct treatment, record reason
text
ECG (Period 1)
Dosing date/time
datetime
Timepoint
integer
Time of ECG
time
Heart rate
integer
PR Interval
integer
QRS Duration
integer
Uncorrected QT Interval
integer
QTc Interval
integer
QTc (b) Interval
integer
Method of QTc Calculation
integer
Result of the ECG
integer
Vital Signs (Period 1)
Dosing date/time (Vital Signs)
datetime
Vital Signs Timepoint
integer
Vital Signs - Actual time
time
Vital Signs - Diastolic Blood Pressure
integer
Vital Signs - Systolic Blood Pressure
integer
Vital Signs - Heart rate
integer
Local Laboratory - Haematology (24Hr Lab) (Period 1)
Date and time sample taken (Haematology, 24 Hr Lab)
datetime
Has the subject fasted? (Haematology, 24 Hr Lab)
boolean
Local Laboratory - Haematology (24 Hr Lab) (Period 1)
Haematologic test (24 Hr Lab)
integer
Numeric result (Haemoatology, 24 Hr Lab)
float
Character result (Haematology, 24 Hr Lab)
text
No result (Haematology, 24 Hr Lab)
integer
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1)
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
datetime
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
boolean
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1)
Clinical Chemistry Test (24 Hr Lab)
integer
Numeric result (Clinical Chemistry, 24 Hr Lab)
float
Character result (Clinical Chemistry, 24 Hr Lab)
text
No result (Clinical Chemistry, 24 Hr Lab)
integer
Pharmacokinetics Blood (Period 1)
Pharmacokinetics Blood (Period 1)
Pharmacokinetics Blood Timepoint
integer
Actual date/time (Pharmacokinetics Blood)
datetime
Pharmacokinetics Urine (Period 1)
Pharmacokinetics Urine (Period 1)
Pharmacokinetics Urine Timepoint
integer
Was all of the sample collected for this interval? (Pharmacokinetics Urine)
boolean
Start date and Actual start time (Pharmacokinetics Urine)
datetime
Stop date and Actual stop time (Pharmacokinetics Urine)
datetime
Total sample volume (Pharmacokinetics Urine)
integer
Summary Holter (Period 1)
Summary Holter (Period 1) (Pre-Dose - 24 hours)
Start Date and Time of Holter
datetime
Stop Date and Time of Holter
datetime
Maximum heart rate
integer
Minimum heart rate
integer
Mean heart rate
integer
Number of ventricular runs
integer
Number of ventricular runs - Not done, specify reason
text
Number of ventricular runs - Not applicable
text
Number of supraventricular runs
integer
Number of supraventricular runs - Not done, specify reason
text
Number of supraventricular runs - Not applicable
text
Interpretation of Holter
integer
Holter Abnormalities (Period 1)
Start Date and Time of Holter
datetime
Stop Date and Time of Holter
datetime
Holter Abnormalities (Period 1)
Holter abnormality
text
Other abnormal rhythm, specify
text
Other morphology, specify
text
Other conduction, specify
text
Other myocardial infarction, specify
text
Other depolarisation/repolrisation, specify
text
Other abnormality/ Cardiologist comments
text
Holter monitoring method
integer
Pulmonary Function Tests (Period 1)
Dosing date/time (Pulmonary Function Tests)
datetime
Pulmonary Function Tests Timepoint
integer
Date/time of test
datetime
FEV1 (3 readings) - 1
integer
FEV1 (3 readings) - 2
integer
FEV1 (3 readings) - 3
integer