ID

32321

Beskrivning

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Nyckelord

Versioner (2)
  1. 2018-10-26 2018-10-26 -
  2. 2019-02-04 2019-02-04 -
Rättsinnehavare

GSK group of companies

Uppladdad den

26 oktober 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride – 106218

Engelsk

Treatment Period 2: Day 1 - 12-lead ECG

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Visit Date
Beskrivning

Visit Date

Datatyp

date

12-lead ECG
Beskrivning

12-lead ECG

ECG Number
Beskrivning

ECG Number

Datatyp

integer

Start Date of ECG
Beskrivning

Start Date of ECG

Datatyp

date

Planned Relative Time
Beskrivning

Planned Relative Time

Datatyp

integer

Start Time of ECG
Beskrivning

Start Time of ECG

Datatyp

time

Ventricular Rate
Beskrivning

Ventricular Rate

Datatyp

integer

Måttenheter
  • bpm
bpm
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
msec
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • msec
msec
Result of the ECG
Beskrivning

enter code for result from the following list

Datatyp

integer

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
Beskrivning

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

Datatyp

text

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Similar models

Treatment Period 2: Day 1 - 12-lead ECG

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Item Group
12-lead ECG
Item
ECG Number
integer
Date
Code List
ECG Number
CL Item
ECG 1 (1)
CL Item
ECG 4 (2)
Start Date of ECG
Item
Start Date of ECG
date
Item
Planned Relative Time
integer
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (ECG 1) (1)
CL Item
24 hrs (ECG 4) (2)
Start Time of ECG
Item
Start Time of ECG
time
Ventricular Rate
Item
Ventricular Rate
integer
PR Interval
Item
PR Interval
integer
QRS Duration
Item
QRS Duration
integer
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
QTc Interval
Item
QTc Interval
integer
Item
Result of the ECG
integer
Result of the ECG
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)
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
Item
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
text
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