ID

32730

Description

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Keywords

Versions (1)
  1. 11/13/18 11/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 13, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

English

PGx-Pharmacogenetic Research Consent

1 forms  
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
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
No informed consent for PGx- Pharmacogenetic research obtained - 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
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]
C0031325
UMLS CUI [1,2]
C0005834
Date sample taken
Description

Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Withdrawal of Consent for PGx (DNA) Sample Destruction
Description

Withdrawal of Consent for PGx (DNA) Sample Destruction

Alias
UMLS CUI-1
C0444245
UMLS CUI-2
C1948029
UMLS CUI-3
C1707492
Has subject withdrawn consent for PGx research?
Description

Pharmacogenetic Test, Consent withdrawn

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1707492
Date informed consent withdrawn
Description

Pharmacogenetic Test, Consent withdrawn, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1707492
UMLS CUI [1,3]
C0011008
Has a request been made for sample destruction?
Description

DNA sample, Destruction, Request

Data type

boolean

Alias
UMLS CUI [1,1]
C0444245
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C1272683
Has a request been made for sample destruction? - Reason
Description

DNA sample, Destruction, Request, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0444245
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
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Similar models

PGx-Pharmacogenetic Research Consent

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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
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
No informed consent for PGx- Pharmacogenetic research obtained - Reason
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Indication
Code List
No informed consent for PGx- Pharmacogenetic research obtained - Reason
CL Item
Subject declined (Subject declined)
CL Item
Subject not asked by Investigator (Subject not asked by Investigator)
CL Item
Other (Other)
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
C0031325 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time
Item
Date sample taken
date
C0031325 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Withdrawal of Consent for PGx (DNA) Sample Destruction
C0444245 (UMLS CUI-1)
C1948029 (UMLS CUI-2)
C1707492 (UMLS CUI-3)
Pharmacogenetic Test, Consent withdrawn
Item
Has subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Pharmacogenetic Test, Consent withdrawn, Date in time
Item
Date informed consent withdrawn
date
C2347500 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
DNA sample, Destruction, Request
Item
Has a request been made for sample destruction?
boolean
C0444245 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
Has a request been made for sample destruction? - Reason
text
C0444245 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
DNA sample, Destruction, Request, Indication
Code List
Has a request been made for sample destruction? - Reason
CL Item
Subject withdrew consent for PGx (Subject withdrew consent for PGx)
CL Item
Screen failure (Screen failure)
CL Item
Other (Other)
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