Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Early Withdrawal
Item
Early Withdrawal
boolean
C2349954 (UMLS CUI [1])
Item
Dose relative to PK sample
integer
C0439564 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Code List
Dose relative to PK sample
CL Item
Prior to PK sample (1)
CL Item
Prior to pre-dose PK sample (2)
CL Item
Immediately after the pre-dose PK sample (3)
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Code List
Investigational Product
CL Item
Open-label tablets (1)
Item
Type of Investigational Product
integer
C0304229 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Type of Investigational Product
Item
Tablets dose received
text
C0039225 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
Code List
Tablets dose received
Suspension dose received
Item
Suspension dose received
integer
C0038960 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1514756 (UMLS CUI [1,4])
Item
Units of dosage
text
C1519795 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Units of dosage
Date dose taken
Item
Date dose taken
date
C0011008 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Time dose taken
Item
Time dose taken
time
C0040223 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Route of investigational product
text
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Route of investigational product
Item
Formulation of investigational product
text
C1705957 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Formulation of investigational product
CL Item
Suspension (SUSP)
Item
Did the subject vomit?
text
C0042963 (UMLS CUI [1])
Code List
Did the subject vomit?
Item
Were dairy products consumed within 4 hours of study drug administration?
text
C0010947 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
Code List
Were dairy products consumed within 4 hours of study drug administration?
Item
Was the required interval (as defined in protocol) between study drug administration and dairy product consumption violated?
text
C1709750 (UMLS CUI [1,1])
C1272706 (UMLS CUI [1,2])
C0010947 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1533734 (UMLS CUI [1,5])
Code List
Was the required interval (as defined in protocol) between study drug administration and dairy product consumption violated?
Dosing Date
Item
Dosing Date
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dosing Time
Item
Dosing Time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time relative to dosage
integer
C0439564 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Code List
Time relative to dosage
CL Item
2 hrs post-dose (2)
CL Item
4 hrs post-dose (3)
CL Item
6 hrs post-dose (4)
CL Item
8 hrs post-dose (5)
CL Item
24 hrs post-dose (6)
Actual Date PK sample taken
Item
Actual Date PK sample taken
date
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Actual Time PK sample taken
Item
Actual Time PK sample taken
date
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])