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ID

32853

Beschreibung

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

Stichworte

Versionen (2)
  1. 19/10/2018 19/10/2018 -
  2. 16/11/2018 16/11/2018 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16 de novembro de 2018

DOI

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

    Englisch

    Study Conclusion Form

    1 Formulare  
    1. StudyEvent: ODM
      1. Study Conclusion Form
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Beschreibung

    Clinical Trial Subject Unique Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Conclusion
    Beschreibung

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008972 (Clinical Research)
    UMLS CUI-2
    C1707478 (Conclusion)
    Date of subject completion or withdrawal
    Beschreibung

    Study End Date; Patient withdrawn from trial, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    UMLS CUI [2,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [2,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Was the subject withdrawn from the study?
    Beschreibung

    Patient withdrawn from trial

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    If YES, mark the primary reason for withdrawal:
    Beschreibung

    Patient withdrawn from trial, Indication

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C3146298 (Indication)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Study Conclusion Form

    1 Formulare
    1. StudyEvent: ODM
      1. Study Conclusion Form
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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