ID

32554

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

12-Lead-ECG

1 forms  
  1. StudyEvent: ODM
    1. 12-Lead-ECG
12-Lead-ECG
Description

12-Lead-ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Description

12 lead ECG, date in time, time

Data type

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Heart rate
Description

12 lead ECG, Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Description

12 lead ECG, PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

12 lead ECG, QRS Complex Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

12 lead ECG, QT Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
Method of QTC Measurement
Description

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C2911685
Machine: QTcB
Description

12 lead ECG, Electrocardiogram QT corrected interval, QTcB Bazett's Correction Formula

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C1882512
msec
Machine: QTcF
Description

12 lead ECG, Electrocardiogram QT corrected interval, Fridiricia Formula

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C4037934
msec
Manual: RR interval
Description

12 lead ECG, Electrocardiogram QT corrected interval, RR interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C0489636
msec
Result of the ECG
Description

12 lead ECG, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C0489636
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Similar models

12-Lead-ECG

1 forms
  1. StudyEvent: ODM
    1. 12-Lead-ECG
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12-Lead-ECG
C0430456 (UMLS CUI-1)
12 lead ECG, date in time, time
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
12 lead ECG, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS Complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
Item
Method of QTC Measurement
text
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
12 lead ECG, Result
Code List
Method of QTC Measurement
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
12 lead ECG, Electrocardiogram QT corrected interval, QTcB Bazett's Correction Formula
Item
Machine: QTcB
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1882512 (UMLS CUI [1,3])
12 lead ECG, Electrocardiogram QT corrected interval, Fridiricia Formula
Item
Machine: QTcF
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C4037934 (UMLS CUI [1,3])
12 lead ECG, Electrocardiogram QT corrected interval, RR interval
Item
Manual: RR interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,3])
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,3])
12 lead ECG, Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
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