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 Treatment Period Subject Diary Card issued on Day 1 (Treatment Period 2) and transcribe the data, as appropriate, to the INVESTIGATIONAL PRODUCT page in this CRF. Collect the study medication issued on Day 1 (Treatment Period 2). If the subject is eligible to continue in the study do the following at the end of this visit: Make an appointment for the subject to return to the clinic in 4-10 days for a Follow-up visit.
text
C0013893 (UMLS CUI [1])
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])