ID

34528

Beschrijving

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

Trefwoorden

Versies (2)
  1. 24-10-18 24-10-18 -
  2. 19-01-19 19-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

19 januari 2019

DOI

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Licentie

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

Engels

Part 2 - Repeat Dose Phase Day 26 - 12-lead ECG

1 Formulieren  
12-Lead ECG
Beschrijving

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beschrijving

12 lead ECG, Numbers

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beschrijving

12 lead ECG, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Beschrijving

12 lead ECG, Relative Time, Planned

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Start Time of ECG
Beschrijving

12 lead ECG, Start Time

Datatype

time

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

Ventricular Rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C2189285
bpm
PR Interval
Beschrijving

PR Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Interval
Beschrijving

Mean QRS Duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C1880451
msec
Uncorrected QT Interval
Beschrijving

QT Interval - finding

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc Interval
Beschrijving

QTc Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Result of the ECG
Beschrijving

12 lead ECG, Result

Datatype

integer

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

Part 2 - Repeat Dose Phase Day 26 - 12-lead ECG

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
text
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
12 lead ECG, Numbers
Code List
ECG Number
CL Item
ECG1 (ECG1)
CL Item
ECG2 (ECG2)
CL Item
ECG3 (ECG3)
CL Item
ECG (ECG)
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
12 lead ECG, Relative Time, Planned
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
Pre-dose (2)
CL Item
Pre-dose (3)
CL Item
24hrs  (4)
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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