ID

35219

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

Versions (1)
  1. 2/25/19 2/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 25, 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

English

PGx - Pharmacogenetic Research

1 forms  
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
Consent for PGx-Pharmacogenetic Research (DNA)
Description

Consent for PGx-Pharmacogenetic Research (DNA)

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
Has informed consent been obtained for PGx-Pharmacogenetic research?
Description

Pharmacogenetic Test, Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
If YES, record the date informed consent obtained for PGx-Pharmacogenetic research
Description

Pharmacogenetic Test, Informed Consent, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
If NO, mark one reason:
Description

Pharmacogenetic Test, Informed Consent, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Blood Sample Collection (DNA)
Description

Blood Sample Collection (DNA)

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0005834
Has a blood sample been collected for PGx-Pharmacogenetic research?
Description

Pharmacogenetic Test, Collection of Blood Specimen for Laboratory Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
If YES, record the date sample taken
Description

Pharmacogenetic Test, Collection of Blood Specimen for Laboratory Procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Withdrawal of Consent
Description

Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Description

Pharmacogenetic Test, Informed Consent, Withdraw

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Blood Sample Destruction
Description

Blood Sample Destruction

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0178913
UMLS CUI-3
C1948029
Has a request been made for blood sample destruction?
Description

Pharmacogenetic Test, Blood Specimen, Destruction, Request

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
If YES, mark one reason:
Description

Pharmacogenetic Test, Blood Specimen, Destruction, Indication

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C3146298
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Similar models

PGx - Pharmacogenetic Research

1 forms
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
Consent for PGx-Pharmacogenetic Research (DNA)
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
Pharmacogenetic Test, Informed Consent
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Pharmacogenetic Test, Informed Consent, Date in time
Item
If YES, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If NO, mark one reason:
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
If NO, mark one reason:
Code List
If NO, mark one reason:
CL Item
[1] Subject declined (1)
CL Item
[2] Subject not asked by Investigator (2)
CL Item
[Z] Other, specify__________________________ (3)
Item Group
Blood Sample Collection (DNA)
C2347500 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Pharmacogenetic Test, Collection of Blood Specimen for Laboratory Procedure
Item
Has a blood sample been collected for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Pharmacogenetic Test, Collection of Blood Specimen for Laboratory Procedure, Date in time
Item
If YES, record the date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent, Withdraw
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Item Group
Blood Sample Destruction
C2347500 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C1948029 (UMLS CUI-3)
Pharmacogenetic Test, Blood Specimen, Destruction, Request
Item
Has a request been made for blood sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
If YES, mark one reason:
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,4])
If YES, mark one reason:
Code List
If YES, mark one reason:
CL Item
[1] Subject requested (1)
CL Item
[2] Screen failure (2)
CL Item
[Z] Other, specify________________________ (3)
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