ID

32853

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. 10/19/18 10/19/18 -
  2. 11/16/18 11/16/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 16, 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

Study Conclusion Form

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion Form
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C1707478
Date of subject completion or withdrawal
Description

Study End Date; Patient withdrawn from trial, Date in time

Data type

date

Alias
UMLS CUI [1]
C2983670
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C0011008
Was the subject withdrawn from the study?
Description

Patient withdrawn from trial

Data type

boolean

Alias
UMLS CUI [1]
C0422727
If YES, mark the primary reason for withdrawal:
Description

Patient withdrawn from trial, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
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Similar models

Study Conclusion Form

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Study Conclusion
C0008972 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Study End Date; Patient withdrawn from trial, Date in time
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If YES, mark the primary reason for withdrawal:
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
If YES, mark the primary reason for withdrawal:
Code List
If YES, mark the primary reason for withdrawal:
CL Item
[1] Adverse event -> Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (1)
CL Item
[2] Lost to follow-up (2)
CL Item
[3] Protocol violation (3)
CL Item
[4] Subject decided to withdraw from the study (4)
CL Item
[6] Sponsor terminated study (5)
CL Item
[Z] Other, specify______________________________ (6)
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