Investigational Product Day 1 - 7
Planned Timepoint
integer
Investigational Product
integer
Investigational Product Start Date
date
Investigational Product Start Time
time
Investigational Prosuct Stop Date
date
Investigational Product Stop Time
time
Investigational Product Dose
float
Investigational Product Units
text
Treatment Corfirmation Day 1 - 7
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 receive the correct treatment, record reason(s)
text
Carbon Monoxide Test - Day 6 PM
Carbon Monoxide Test - Date sample taken
date
Carbon Monoxide Test - Results
integer
Carbon Monoxide Test - Results
integer
Urine Test for Drugs of Abuse
Urine Test for Drugs of Abuse
Urine Test for Drugs of Abuse
integer
Vital Signs - Day 7
Vital Signs - Date
date
Vital Signs - Planned Relative Time
integer
Vital Signs - Actual Time
time
Vital Signs - Systolic Blood Pressure
integer
Vital Signs - Diastolic Blood Pressure
integer
Vital Signs - Heart Rate
integer
12-Lead ECG - Day 7
Start Date of ECG
date
12-Lead ECG - Planned Relative Time
integer
Start Time of ECG
time
12-Lead ECG - Ventricular Rate
integer
12-Lead ECG - PR Interval
integer
12-Lead ECG - QRS Duration
integer
12-Lead ECG - Uncorrected QT Interval
integer
12-Lead ECG - QTc Interval
integer
12-Lead ECG - Result
integer
12-Lead ECG Abnormalities - Day 7
12-Lead ECG Abnormalities - Day 7
A. Rhythm
text
Other abnormal rhythm - Comment
text
B. P-Wave and QRS Morphology
text
Other P-Wave and QRS Morphology - Comment
text
C. Conduction
text
Other Conduction - Comment
text
D. Myocaridal Infarction
text
Other Myocardial Infarction - Comment
text
E. Depolarisation/ Repolarisation (QRS-T)
text
Other Depolarisation/ Repolarisation (QRS-T) - Comment
text
Other abnormalities
text
Other abnormalities - Comment
text
Pulmonary Function Test - Day 7
Pulmonary Function Tests - Date
date
Pulmonary Function Test
integer
Pulmonary Function Tests - Units
integer
Pulmonary Function Tests - Planned Relative Time
integer
Pulmonary Function Tests - Actual Time of First Reading
time
Pulmonary Function Tests - Reading 1
float
Pulmonary Function Tests - Reading 2
float
Pulmonary Function Tests - Reading 3
float