Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Compliance behavior
Item
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
boolean
C1321605 (UMLS CUI [1])
Compliance behavior limited
Item
Is the subject aware of any forthcoming requirements?
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Concomitant medications
Item
Has the subject used any concomitant medications?
boolean
C2347852 (UMLS CUI [1])
Health status change
Item
Has there been any change in the state of the subject's health?
boolean
C0018759 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Eligibility
Item
Collect the Run-in Subject Diary Card issued at the Run-in visit and transcribe the data, as appropriate, to the INVESTIGATIONAL PRODUCT page in this CRF. Collect the Run-in study medication issued at the Run-in visit. If the subject is eligible to continue in the study: Issue the Treatment Period Subject Diary Card and instruct the subject how it should be completed Emphasize to the subject the importance of completing it at the required time each morning and evening. Issue study medication Make an appointment for the subject to return in 5, 6, or 7 days time, as appropriate.
text
C0013893 (UMLS CUI [1])
Reminder
Item
Remind the subject to bring the following to the next visit: completed Treatment Period Subject Diary Card and study medication. Not to take study medication on the morning of the next clinic visit.
text
C1709896 (UMLS CUI [1])
Specimen collection
Item
Date sample taken
date
C0200345 (UMLS CUI [1,1])
C0038577 (UMLS CUI [1,2])
Item
Drug screening Positive finding
integer
C0038577 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Code List
Drug screening Positive finding
CL Item
Benzod iazepines (5)
Item
Drug screening Negative finding
integer
C0038577 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Code List
Drug screening Negative finding
CL Item
Benzod iazepines (5)
pregnancy test
Item
Is a pregnancy test applicable?
boolean
C0032976 (UMLS CUI [1])
pregnancy test
Item
If YES, was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Item
Pregnancy test result, tick one
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Pregnancy test result, tick one
Vital Signs Assessment Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Code List
Planned Relative Time
vital signs time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
sample date
Item
Date
date
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Code List
Planned Relative Time
Actual time of specimen collection
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Sample number
Item
Sample number
integer
C1299222 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
PK sample taken
Item
PK sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
Vital Signs Assessment Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Code List
Planned Relative Time
vital signs time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
sample date
Item
Date
date
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Code List
Planned Relative Time
CL Item
1.5hrs (7)
(Comment:en)
CL Item
2hrs (8)
(Comment:en)
CL Item
3hrs (9)
(Comment:en)
CL Item
5hrs (10)
(Comment:en)
CL Item
10hrs (11)
(Comment:en)
CL Item
12hrs (12)
(Comment:en)
Actual time of specimen collection
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Sample number
Item
Sample number
integer
C1299222 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
PK sample taken
Item
PK sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])