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Part 2 - Repeat Dose Phase Day 23 - Investigational Product/Treatment Confirmation

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Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Timepoint
Beschrijving

Experimental Drug, Timepoint, Planned

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1301732
Investigational Product
Beschrijving

Experimental Drug

Datatype

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beschrijving

Experimental Drug, Dosage, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Beschrijving

Experimental Drug, Dosage, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Treatment Confirmation
Beschrijving

Treatment Confirmation

Alias
UMLS CUI-1
C008711
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Beschrijving

Therapeutic Procedure, Correct

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
If No, record reason(s)
Beschrijving

Therapeutic Procedure, Wrong, Indication

Datatype

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C3146298
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Similar models

Part 2 - Repeat Dose Phase Day 23 - Investigational Product/Treatment Confirmation

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Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 23 AM (1)
CL Item
Day 23 AM (2)
CL Item
Day 23 PM (3)
CL Item
Day 23 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
C008711 (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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