ID

32725

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

Vital Signs

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs
Timepoint 1 Supine
Description

Timepoint 1 Supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0038846
Actual date/time
Description

Vital Signs, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

float

Alias
UMLS CUI [1]
C1305855
Blood pressure systolic
Description

Systolic pressure, Supine Position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood pressure diastolic
Description

Diastolic Blood Pressure, Supine position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Description

Heart rate, Supine position

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
bpm
Standing
Description

Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0231472
Actual time
Description

Vital Signs, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Blood pressure systolic
Description

Systolic pressure, Standing position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Blood pressure diastolic
Description

Diastolic Blood Pressure, Standing position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Heart rate
Description

Heart rate, Standing position

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
bpm
Timepoint 2 Supine
Description

Timepoint 2 Supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0038846
Actual date/time
Description

Vital Signs, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Blood pressure systolic
Description

Systolic pressure, Supine Position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood pressure diastolic
Description

Diastolic Blood Pressure, Supine position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Description

Heart rate, Supine position

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
bpm
Standing
Description

Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0231472
Actual time
Description

Vital Signs, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Blood pressure systolic
Description

Systolic pressure, Standing position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Blood pressure diastolic
Description

Diastolic Blood Pressure, Standing position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Heart rate
Description

Heart rate, Standing position

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
bpm
Timepoint 3 Supine
Description

Timepoint 3 Supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0038846
Actual date/time
Description

Vital Signs, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Blood pressure systolic
Description

Systolic pressure, Supine Position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood pressure diastolic
Description

Diastolic Blood Pressure, Supine position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Description

Heart rate, Supine position

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
bpm
Standing
Description

Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0231472
Actual time
Description

Vital Signs, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Blood pressure systolic
Description

Systolic pressure, Standing position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Blood pressure diastolic
Description

Diastolic Blood Pressure, Standing position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Heart rate
Description

Heart rate, Standing position

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
bpm
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Similar models

Vital Signs

1 forms
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Timepoint 1 Supine
C0518766 (UMLS CUI-1)
C0038846 (UMLS CUI-2)
Vital Signs, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic pressure, Supine Position
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure, Supine position
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate, Supine position
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Item Group
Standing
C0518766 (UMLS CUI-1)
C0231472 (UMLS CUI-2)
Vital Signs, Date in time, Time
Item
Actual time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Systolic pressure, Standing position
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood Pressure, Standing position
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate, Standing position
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Item Group
Timepoint 2 Supine
C0518766 (UMLS CUI-1)
C0038846 (UMLS CUI-2)
Vital Signs, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Systolic pressure, Supine Position
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure, Supine position
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate, Supine position
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Item Group
Standing
C0518766 (UMLS CUI-1)
C0231472 (UMLS CUI-2)
Vital Signs, Date in time, Time
Item
Actual time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Systolic pressure, Standing position
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood Pressure, Standing position
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate, Standing position
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Item Group
Timepoint 3 Supine
C0518766 (UMLS CUI-1)
C0038846 (UMLS CUI-2)
Vital Signs, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Systolic pressure, Supine Position
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure, Supine position
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate, Supine position
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Item Group
Standing
C0518766 (UMLS CUI-1)
C0231472 (UMLS CUI-2)
Vital Signs, Date in time, Time
Item
Actual time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Systolic pressure, Standing position
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood Pressure, Standing position
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate, Standing position
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
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