ID

32560

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. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 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

Logs and Repeats

1 forms  
  1. StudyEvent: ODM
    1. Logs and Repeats
Date of visit/assessment
Description

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Description

Date of visit, Assessment date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Adverse Event/Concomitant Medication/Repeat Assessment
Description

Adverse Event/Concomitant Medication/Repeat Assessment

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C1516048
Were any concomitant medications taken by the subject during the study?
Description

Concomitant Agent

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Description

Non-serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Does the subject have any past or current Medical Conditions?
Description

Disease

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Has the subject had any Medical/Surgical Procedures?
Description

Surgical and medical procedures

Data type

boolean

Alias
UMLS CUI [1]
C1948041
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Description

Electrocardiogram abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0522055
Were any repeat ECGs performed?
Description

Electrocardiogram, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205341
Were any repeat vital signs recorded?
Description

Vital Signs, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat PK blood samples taken?
Description

Pharmacokinetic study, Blood sample taken, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C1277698
UMLS CUI [1,3]
C0205341
Were there any Unscheduled Investigational Product dispensed or returned?
Description

Experimental drug, Dispensing medication; Experimental drug, Return

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0947323
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0332156
Liver Event
Description

Liver Event

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

Liver Function, Chemistry, Laboratory test finding

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
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Similar models

Logs and Repeats

1 forms
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit, Assessment date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Adverse Event/Concomitant Medication/Repeat Assessment
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C1516048 (UMLS CUI-3)
Concomitant Agent
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Non-serious Adverse Event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Serious Adverse Event
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Disease
Item
Does the subject have any past or current Medical Conditions?
boolean
C0012634 (UMLS CUI [1])
Surgical and medical procedures
Item
Has the subject had any Medical/Surgical Procedures?
boolean
C1948041 (UMLS CUI [1])
Electrocardiogram abnormal
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
Electrocardiogram, Repeat
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Vital Signs, Repeat
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Pharmacokinetic study, Blood sample taken, Repeat
Item
Were any repeat PK blood samples taken?
boolean
C0201734 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Experimental drug, Dispensing medication; Experimental drug, Return
Item
Were there any Unscheduled Investigational Product dispensed or returned?
boolean
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0332156 (UMLS CUI [2,2])
Item Group
Liver Event
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Liver Function, Chemistry, Laboratory test finding
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
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