ID

34086

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 (2)
  1. 10/23/18 10/23/18 -
  2. 1/14/19 1/14/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 14, 2019

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 -1 - 12-lead ECG (Semi-Supine)

1 forms  
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Description

12 lead ECG, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Description

12 lead ECG, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Description

Ventricular Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2189285
bpm
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Interval
Description

Mean QRS Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
Uncorrected QT Interval
Description

QT Interval - finding

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Result of the ECG
Description

12 lead ECG, Result

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
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Similar models

Part 2 - Treatment Period day -1 - 12-lead ECG (Semi-Supine)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
12 lead ECG, Start Time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
Mean QRS Duration
Item
QRS Interval
integer
C1880451 (UMLS CUI [1])
QT Interval - finding
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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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