ID

34086

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. 23-10-18 23-10-18 -
  2. 14-01-19 14-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

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

1 Formulieren  
12-Lead ECG
Beschrijving

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Beschrijving

12 lead ECG, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
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
Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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