ID

37903

Beschreibung

Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Stichworte

Versionen (1)
  1. 29.08.19 29.08.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

29. August 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036

    Englisch

    Study Conclusion

    1 Formulare  
    1. StudyEvent: ODM
      1. Study Conclusion
    Study Conclusion
    Beschreibung

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C1707478
    Date/time of subject completion or withdrawal
    Beschreibung

    Clinical Trials, Conclusion, Date in time, Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C1707478
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Was the subject withdrawn from the study?
    Beschreibung

    Clinical Trials, Withdraw

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    If Yes, specify primary reason for withdrawal
    Beschreibung

    Clinical Trials, Withdraw, Reason and justification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    Specify
    Beschreibung

    Clinical Trials, Withdraw, Reason and justification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    Case book ready for signature
    Beschreibung

    Clinical Trials, Clinical Study Case, Signature

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C1706256
    UMLS CUI [1,3]
    C1519316
    Office Use 1
    Beschreibung

    Clinical Trials, Conclusion, Office

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C1707478
    UMLS CUI [1,3]
    C0442603
    Office Use 2
    Beschreibung

    Clinical Trials, Conclusion, Office

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C1707478
    UMLS CUI [1,3]
    C0442603
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    Ähnliche Modelle

    Study Conclusion

    1 Formulare
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Study Conclusion
    C0008976 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Clinical Trials, Conclusion, Date in time, Time
    Item
    Date/time of subject completion or withdrawal
    datetime
    C0008976 (UMLS CUI [1,1])
    C1707478 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Clinical Trials, Withdraw
    Item
    Was the subject withdrawn from the study?
    boolean
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Item
    If Yes, specify primary reason for withdrawal
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Clinical Trials, Withdraw, Reason and justification
    Code List
    If Yes, specify primary reason for withdrawal
    CL Item
    Adverse event (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from study (4)
    CL Item
    Sponsor terminated study (5)
    CL Item
    Other, specify (6)
    Clinical Trials, Withdraw, Reason and justification
    Item
    Specify
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Clinical Trials, Clinical Study Case, Signature
    Item
    Case book ready for signature
    boolean
    C0008976 (UMLS CUI [1,1])
    C1706256 (UMLS CUI [1,2])
    C1519316 (UMLS CUI [1,3])
    Clinical Trials, Conclusion, Office
    Item
    Office Use 1
    boolean
    C0008976 (UMLS CUI [1,1])
    C1707478 (UMLS CUI [1,2])
    C0442603 (UMLS CUI [1,3])
    Item
    Office Use 2
    text
    C0008976 (UMLS CUI [1,1])
    C1707478 (UMLS CUI [1,2])
    C0442603 (UMLS CUI [1,3])
    Clinical Trials, Conclusion, Office
    Code List
    Office Use 2
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
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