Part 2 - Repeat Dose Phase Day 22 - Investigational Product/Treatment Confirmation

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned Timepoint
text
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Experimental Drug, Timepoint, Planned
Code List
Planned Timepoint
CL Item
Day 21 AM (1)
CL Item
Day 21 AM (2)
CL Item
Day 21 PM (3)
CL Item
Day 21 PM (4)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Experimental Drug, Timepoint, Planned
Code List
Investigational Product
CL Item
Dustasteride (1)
CL Item
Testosterone (2)
CL Item
Dustasteride (3)
CL Item
Testosterone (4)
Experimental Drug, Dosage, Date in time
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental Drug, Dosage, Time
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic Procedure, Correct
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Therapeutic Procedure, Wrong, Indication
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
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