ID

40812

Description

Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Keywords

Versions (1)
  1. 5/17/20 5/17/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 17, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484

English

PGx

1 forms  
  1. StudyEvent: ODM
    1. PGx
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit/assessment
Description

Date of visit, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
PGx-Pharmacogenetic Research Consent
Description

PGx-Pharmacogenetic Research Consent

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
Yes, record 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
Yes, Has a blood sample been collected for PGx-Pharmacogenetic (DNA) 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
Yes, record 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
No, check reason
Description

Pharmacogenetic Test, Informed Consent, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0566251
Other, specify
Description

Pharmacogenetic Test, Informed Consent, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0566251
Withdrawal of Consent for PGx
Description

Withdrawal of Consent for PGx

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
Has subject withdrawn consent for PGx 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
Yes, date informed consent withdrawn
Description

Pharmacogenetic Test, Informed Consent, Withdraw, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
Has a request been made for 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
Yes, check reason
Description

Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0566251
Other, specify
Description

Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0566251
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Similar models

PGx

1 forms
  1. StudyEvent: ODM
    1. PGx
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
PGx-Pharmacogenetic Research Consent
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
Yes, record Date informed consent obtained for PGx-Pharmacogenetic Research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Item
Yes, Has a blood sample been collected for PGx-Pharmacogenetic (DNA) 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
Yes, record date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
No, check reason
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Reason and justification
Code List
No, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Item
Other, specify
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Reason and justification
Code List
Other, specify
Item Group
Withdrawal of Consent for PGx
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent, Withdraw
Item
Has subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
Item
Yes, date informed consent withdrawn
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacogenetic Test, Blood specimen, Destruction, Request
Item
Has a request been made for sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Yes, check reason
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Code List
Yes, check reason
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Item
Other, specify
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
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