ID

44764

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 (3)
  1. 11/13/18 11/13/18 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 11/17/21 11/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 17, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

English

Liver Events

1 forms  
  1. StudyEvent: ODM
    1. Liver Events
Seriousness of Liver Event
Description

Seriousness of Liver Event

Alias
UMLS CUI-1
C1556667
UMLS CUI-2
C1519255
Is this liver event a serious adverse event?
Description

Liver Dysfunction or Failure by Clinical Classification Adverse Event, Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C1556667
UMLS CUI [1,2]
C1519255
Notification
Description

Notification

Alias
UMLS CUI-1
C1556667
UMLS CUI-2
C0422202
Last Email Sent to Medical Monitor
Description

Email, last, Medical Monitor, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013849
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1708968
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Initial Email Sent to Medical Monitor
Description

Email, first, Medical Monitor, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013849
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1708968
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Last Email Sent to GCSP
Description

Email, Last, Clinical Trial Safety Documentation, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013849
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C3899555
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Initial Email Sent to GCSP
Description

Email, First, Clinical Trial Safety Documentation, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013849
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C3899555
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Changed to Non Serious on
Description

Liver Dysfunction or Failure by Clinical Classification Adverse Event, Non-serious Adverse Event, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1556667
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Liver Chemistry
Description

Liver Chemistry

Alias
UMLS CUI-1
C0232741
UMLS CUI-2
C0022885
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/interruption criteria?
Description

Liver function, Laboratory procedures

Data type

text

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0022885
Medical History
Description

Medical History

Alias
UMLS CUI-1
C0262926
Is the subject age 55 or older?
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
If female, is the subject pregnant?
Description

Pregnancy

Data type

text

Alias
UMLS CUI [1]
C0032961
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Description

Liver, Diagnostic Imaging; Hepatobiliary System, Diagnostic Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C1711359
UMLS CUI [2,2]
C0011923
If Yes, were the results normal?
Description

Liver, Diagnostic Imaging, Results; Hepatobiliary System, Diagnostic Imaging, Results

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C1274040
UMLS CUI [2,1]
C1711359
UMLS CUI [2,2]
C0011923
UMLS CUI [2,3]
C1274040
Were any liver biopsies performed?
Description

Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1]
C0193388
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Description

Herbal medicine; Complementary Medicine; Alternative Medicine; Dietary Supplements; Illicit medication use

Data type

boolean

Alias
UMLS CUI [1]
C2240391
UMLS CUI [2]
C1148474
UMLS CUI [3]
C0002346
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0281875
Did the subject fast or undergo significant dietary change in the past week?
Description

Fasting, Change in Diet

Data type

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C3671772
Investigational Product (Liver)
Description

Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
When did the liver event occur?
Description

Liver Dysfunction or Failure by Clinical Classification Adverse Event, Experimental Drug

Data type

text

Alias
UMLS CUI [1,1]
C1556667
UMLS CUI [1,2]
C0304229
Start Date Investigational Products
Description

Experimental Drug, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
End Date Investigational Products
Description

Experimental Drug, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
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Similar models

Liver Events

1 forms
  1. StudyEvent: ODM
    1. Liver Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Seriousness of Liver Event
C1556667 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Liver Dysfunction or Failure by Clinical Classification Adverse Event, Serious Adverse Event
Item
Is this liver event a serious adverse event?
boolean
C1556667 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Notification
C1556667 (UMLS CUI-1)
C0422202 (UMLS CUI-2)
Email, last, Medical Monitor, Date in time, Time
Item
Last Email Sent to Medical Monitor
datetime
C0013849 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Email, first, Medical Monitor, Date in time, Time
Item
Initial Email Sent to Medical Monitor
datetime
C0013849 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Email, Last, Clinical Trial Safety Documentation, Date in time, Time
Item
Last Email Sent to GCSP
datetime
C0013849 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C3899555 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Email, First, Clinical Trial Safety Documentation, Date in time, Time
Item
Initial Email Sent to GCSP
datetime
C0013849 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C3899555 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Liver Dysfunction or Failure by Clinical Classification Adverse Event, Non-serious Adverse Event, Date in time, Time
Item
Changed to Non Serious on
datetime
C1556667 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Liver Chemistry
C0232741 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Item
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/interruption criteria?
text
C0232741 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Liver function, Laboratory procedures
Code List
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/interruption criteria?
CL Item
ALT (alanine aminotransferase)  (1)
CL Item
AST (aspartate aminotransferase)  (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5` nucleotidase  (5)
CL Item
Gammaglutamyltranspeptidase  (6)
CL Item
Other (7)
Item Group
Medical History
C0262926 (UMLS CUI-1)
Age
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
If female, is the subject pregnant?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
Liver, Diagnostic Imaging; Hepatobiliary System, Diagnostic Imaging
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0023884 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C1711359 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Liver, Diagnostic Imaging, Results; Hepatobiliary System, Diagnostic Imaging, Results
Item
If Yes, were the results normal?
boolean
C0023884 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1711359 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C1274040 (UMLS CUI [2,3])
Biopsy of liver
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Herbal medicine; Complementary Medicine; Alternative Medicine; Dietary Supplements; Illicit medication use
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
Fasting, Change in Diet
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1,1])
C3671772 (UMLS CUI [1,2])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
When did the liver event occur?
text
C1556667 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Liver Event, Experimental Drug
Code List
When did the liver event occur?
CL Item
During the treatment period (During the treatment period)
CL Item
After the treatment period (After the treatment period)
Experimental Drug, Start Date
Item
Start Date Investigational Products
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Experimental Drug, End Date
Item
End Date Investigational Products
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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