Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Date Dispensed
Item
Date Dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Total number of sachets/tablets dispensed
Item
Total number of sachets/tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Container number
Item
Container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Did the subject return the investigational product?
text
C0332156 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Did the subject return the investigational product?
Date of subject return the investigational product
Item
Date of subject return the investigational product
date
C0332156 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Total number of sachets/tablets returned
Item
Total number of sachets/tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2699071 (UMLS CUI [2,1])
C0039225 (UMLS CUI [2,2])
No return of investigational product, specification
Item
No return of investigational product, specification
text
C1298908 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Investigational Product open-label
Item
Investigational Product. Tick if Open-label tablets
boolean
C0304229 (UMLS CUI [1,1])
C3640652 (UMLS CUI [1,2])
Item
Tablets dose received
integer
C0039225 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
Code List
Tablets dose received
CL Item
0 mg (Dose interruption period) (0)
CL Item
Alternating Dose (7)
Alternating dose
Item
If alternating tablets dose, please specify
text
C0332270 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
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
Frequency of investigational product
text
C0439603 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Frequency of investigational product
CL Item
Every other day (QOD)
CL Item
Every 3 days (Q3D)
CL Item
Every 4 days (Q4D)
CL Item
Every 5 days (Q5D)
CL Item
Every 6 days (Q6D)
CL Item
Twice weekly (2XW)
CL Item
3 times a week (3XW)
CL Item
4 times a week (4XW)
CL Item
5 times a week (5XW)
CL Item
6 times a week (6XW)
Item
Units of dosage
text
C1519795 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Units of dosage
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 receive the correct treatment/dose (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
C2349182 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
C1272706 (UMLS CUI [2,5])
Code List
Did the subject receive the correct treatment/dose (e.g., treatment which the subject was assigned to) during this dosing interval?
No correct treatment/dose, reason
Item
If there was no correct treatment/dose during dosage interval, please record reason(s)
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0392360 (UMLS CUI [2,1])
C1298908 (UMLS CUI [2,2])
C2349182 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])