ID

32312

Description

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

Keywords

Versions (3)
  1. 10/26/18 10/26/18 -
  2. 10/26/18 10/26/18 -
  3. 1/14/19 1/14/19 -
Copyright Holder

GSK group of companies

Uploaded on

October 26, 2018

DOI

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License

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

English

Part 2: Treatment Period - Day 15 - 12-lead ECG Form

1 forms  
Administrative data
Description

Administrative data

Subject Identifier
Description

Subject Identifier

Data type

integer

Visit Date
Description

Visit Date

Data type

date

12-lead ECG
Description

12-lead ECG

Start Date of ECG
Description

Start Date of ECG

Data type

date

Start Time of ECG
Description

Start Time of ECG

Data type

time

Ventricular Rate
Description

Ventricular Rate

Data type

integer

Measurement units
  • bpm
bpm
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • msec
msec
QRS Interval
Description

QRS Interval

Data type

integer

Measurement units
  • msec
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • msec
msec
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • msec
msec
Result of the ECG
Description

Mark one

Data type

integer

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Similar models

Part 2: Treatment Period - Day 15 - 12-lead ECG Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Item Group
12-lead ECG
Start Date of ECG
Item
Start Date of ECG
date
Start Time of ECG
Item
Start Time of ECG
time
Ventricular Rate
Item
Ventricular Rate
integer
PR Interval
Item
PR Interval
integer
QRS Interval
Item
QRS Interval
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 (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.) (3)
CL Item
No result (not available) (4)
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