ID

34120

Description

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Keywords

  1. 10/24/18 10/24/18 -
  2. 1/14/19 1/14/19 -
  3. 3/4/19 3/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 14, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

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

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Timepoint
Description

Experimental Drug, Timepoint, Planned

Data type

text

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

Experimental Drug

Data type

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Description

Experimental Drug, Dosage, Date in time

Data type

date

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

Experimental Drug, Dosage, Time

Data type

time

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

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?
Description

Therapeutic Procedure, Correct

Data type

boolean

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

Therapeutic Procedure, Wrong, Indication

Data type

text

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

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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])
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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