Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Pregnancy Tests, Applicable
Item
Is a pregnancy test applicable?
boolean
C0032976 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Pregnancy Tests, Diagnostic procedures performed
Item
If YES, was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1,1])
C3259360 (UMLS CUI [1,2])
Pregnancy Tests, Sampling, Date in time
Item
Date pregnancy sample taken
date
C0032976 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If YES, pregnancy test result, check one
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
If YES, pregnancy test result, check one
CL Item
Record time of dose of Investigational Product (2)
CL Item
2 min post-dose (3)
CL Item
5 min post-dose (4)
CL Item
10 min post-dose (5)
CL Item
15 min post-dose (6)
CL Item
20 min post-dose (7)
CL Item
30 min post-dose (8)
CL Item
45 min post-dose (9)
CL Item
60 min post-dose (10)
CL Item
1.25 hr post-dose (11)
CL Item
1.5 hr post-dose (12)
CL Item
2 hr post-dose (13)
CL Item
2.5 hr post-dose (14)
CL Item
3 hr post-dose (15)
CL Item
4 hr post-dose (16)
CL Item
6 hr post-dose (17)
CL Item
8 hr post-dose (18)
CL Item
12 hr post-dose (19)
Item
Planned time
text
C2826762 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
CL Item
Record time of dose of Investigational Product (2)
CL Item
2 min post-dose (3)
CL Item
5 min post-dose (4)
CL Item
10 min post-dose (5)
CL Item
15 min post-dose (6)
CL Item
20 min post-dose (7)
CL Item
30 min post-dose (8)
CL Item
45 min post-dose (9)
CL Item
60 min post-dose (10)
CL Item
1.25 hr post-dose (11)
CL Item
1.5 hr post-dose (12)
CL Item
2 hr post-dose (13)
CL Item
2.5 hr post-dose (14)
CL Item
3 hr post-dose (15)
CL Item
4 hr post-dose (16)
CL Item
6 hr post-dose (17)
CL Item
8 hr post-dose (18)
CL Item
12 hr post-dose (19)
Drug screen, Sampling, Date in time
Item
Date sample taken
date
C0373483 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Drug screen, Illicit Drugs
Item
Drug
text
C0373483 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
Drug screen, Result
Item
Result
text
C0373483 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Planned time
text
C2826762 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
CL Item
Record time of dose of Investigational Product (2)
CL Item
2 min post-dose (3)
CL Item
5 min post-dose (4)
CL Item
10 min post-dose (5)
CL Item
15 min post-dose (6)
CL Item
20 min post-dose (7)
CL Item
30 min post-dose (8)
CL Item
45 min post-dose (9)
CL Item
60 min post-dose (10)
CL Item
1.25 hr post-dose (11)
CL Item
1.5 hr post-dose (12)
CL Item
2 hr post-dose (13)
CL Item
2.5 hr post-dose (14)
CL Item
3 hr post-dose (15)
CL Item
4 hr post-dose (16)
CL Item
6 hr post-dose (17)
CL Item
8 hr post-dose (18)
CL Item
12 hr post-dose (19)
Systolic Pressure
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item
Row number
text
C0851347 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
CL Item
Record time of dose of Investigational Product (2)
CL Item
2 min post-dose (3)
CL Item
5 min post-dose (4)
CL Item
10 min post-dose (5)
CL Item
15 min post-dose (6)
CL Item
20 min post-dose (7)
CL Item
30 min post-dose (8)
CL Item
45 min post-dose (9)
CL Item
60 min post-dose (10)
CL Item
1.25 hr post-dose (11)
CL Item
1.5 hr post-dose (12)
CL Item
2 hr post-dose (13)
CL Item
2.5 hr post-dose (14)
CL Item
3 hr post-dose (15)
CL Item
4 hr post-dose (16)
CL Item
6 hr post-dose (17)
CL Item
8 hr post-dose (18)
CL Item
12 hr post-dose (19)
Pharmacokinetic aspects, Sampling, Date in time
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Planned relative time
text
C0851347 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Code List
Planned relative time
CL Item
Record time of dose of Investigational Product (2)
CL Item
2 min post-dose (3)
CL Item
5 min post-dose (4)
CL Item
10 min post-dose (5)
CL Item
15 min post-dose (6)
CL Item
20 min post-dose (7)
CL Item
30 min post-dose (8)
CL Item
45 min post-dose (9)
CL Item
60 min post-dose (10)
CL Item
1.25 hr post-dose (11)
CL Item
1.5 hr post-dose (12)
CL Item
2 hr post-dose (13)
CL Item
2.5 hr post-dose (14)
CL Item
3 hr post-dose (15)
CL Item
4 hr post-dose (16)
CL Item
6 hr post-dose (17)
CL Item
8 hr post-dose (18)
CL Item
12 hr post-dose (19)
Pharmacokinetic aspects, Sampling, Time
Item
Actual time
time
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Sample number
text
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Pharmacokinetic aspects, Sampling, Taken
Item
5 mL sample, check if taken
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
Experimental drug, Start Date
Item
Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Experimental drug, End Date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Experimental drug, Changed status
Item
Were there any significant changes to investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Experimental drug, Changed status, Details
Item
If YES, specify investigational product changes, dates, and reasons
text
C0304229 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])