Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
Item Group
Sample 02: 1 hr Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 03: 2 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 04: 4 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 05: 6 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 06: 8 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 07: 10 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 08: 12 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Sample 09: 14 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Sample 10: 16 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Sample 11: 20 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Sample 12: 24 hrs Post-Dose Study Period Visit 2 (Day 1)
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Taking of a blood sample Study Period Visit 4 (Day 8)
C1277698 (UMLS CUI-1)
date sample taken
Item
Date plasma samples drawn
date
C1302413 (UMLS CUI [1])
Item Group
Sample 01: Specified Time Pre-Dose Study Period Visit 4 (Day 8)
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
time of plasma sample
Item
Actual Time of Plasma Sample
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate in supine position
Item
Supine Heart Rate
integer
C3262833 (UMLS CUI [1])
heart rate in standing position
Item
Standing Heart Rate
integer
C2029905 (UMLS CUI [1])
blood pressure in supine position
Item
Supine Blood Pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
blood pressure in standing position
Item
Standing Blood Pressure
integer
C0580945 (UMLS CUI [1])
Item Group
Deviations Study Period Visit 4 (Day 8)
C0033213 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Item
Were there any important deviations from the scheduled sampling?
integer
C0033213 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Code List
Were there any important deviations from the scheduled sampling?
deviations in blood sample taking
Item
Were there any important deviations from the scheduled sampling?
text
C0033213 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item Group
Sample Collection Study Period Visit 4 (Day 8)
C0200345 (UMLS CUI-1)
shipping date of blood samples
Item
Shipping date of blood samples
date
C0370003 (UMLS CUI [1,1])
C1524049 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Samples were collected and processed as per protocol?
integer
C0200345 (UMLS CUI [1,1])
C1507394 (UMLS CUI [1,2])
Code List
Samples were collected and processed as per protocol?