ID

32321

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

  1. 10/26/18 10/26/18 -
  2. 2/4/19 2/4/19 -
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

Treatment Period 2: Day 1 - 12-lead ECG

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

ECG Number
Description

ECG Number

Data type

integer

Start Date of ECG
Description

Start Date of ECG

Data type

date

Planned Relative Time
Description

Planned Relative Time

Data type

integer

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 Duration
Description

QRS Duration

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

enter code for result from the following list

Data type

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.
Description

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.

Data type

text

Similar models

Treatment Period 2: Day 1 - 12-lead ECG

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
Item
ECG Number
integer
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
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
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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