0 Ratings
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

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    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    Study End Date; Patient withdrawn from trial, Date in time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    Was the subject withdrawn from the study?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    Patient withdrawn from trial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    Patient withdrawn from trial, Indication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
    Back to the top of the page

    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)
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial