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ID

33053

Description

This form contains a form to document the study conclusion and pregnancy information. To be assessed at the follow-up visit. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Link

https://clinicaltrials.gov/ct2/show/NCT00875784

Keywords

Versions (2)
  1. 11/25/18 11/25/18 -
  2. 11/25/18 11/25/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 25, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784

    English

    Study Conclusion and Pregnancy Information

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    Date of subject completion or withdrawal
    Description

    Date of subject completion or withdrawal

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670
    Was the subject withdrawn from the study?
    Description

    If yes, complete primary reason for witltdrawal

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727
    If the subject was withdrawn from the study, complete the primary reason:
    Description

    In case you tick Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. In case you tick Investigator discretion, specify in the next item. Select this reason if none of the other primary reasons are appropriate.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    If you ticked 'Investigator discretion' as primary reason for withdrawal, specify
    Description

    Withdrawal from the study at the investigator's discretion, specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C1710220
    UMLS CUI [1,3]
    C0679006
    UMLS CUI [1,4]
    C2348235
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did a female partner of the male subject become pregnant during the study?
    Description

    if Yes, complete the paper Pregnancy Notification form Check Not Applicable iffemale partner not of childbearing potential or no female partner

    Data type

    text

    Alias
    UMLS CUI [1]
    C0919624
    Did the subject become pregnant during the study?
    Description

    If Yes, complete the paper Pregnancy Notification form

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032961
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    Similar models

    Study Conclusion and Pregnancy Information

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    Item
    Was the subject withdrawn from the study?
    text
    C0422727 (UMLS CUI [1])
    Subject withdrawn from the study
    Code List
    Was the subject withdrawn from the study?
    CL Item
    No (No)
    CL Item
    Yes (Yes)
    Item
    If the subject was withdrawn from the study, complete the primary reason:
    text
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary reason for withdrawal
    Code List
    If the subject was withdrawn from the study, complete the primary reason:
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Protocol deviation (Protocol deviation)
    CL Item
    Subject reached protocol defined stopping criteria (Subject reached protocol defined stopping criteria)
    CL Item
    Study closed/terminated (Study closed/terminated)
    CL Item
    Lost to Follow-up (Lost to Follow-up)
    CL Item
    Investigator discretion, specify (Investigator discretion, specify)
    CL Item
    Withdrew consent (Withdrew consent)
    Withdrawal from the study at the investigator's discretion, specification
    Item
    If you ticked 'Investigator discretion' as primary reason for withdrawal, specify
    text
    C2349954 (UMLS CUI [1,1])
    C1710220 (UMLS CUI [1,2])
    C0679006 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did a female partner of the male subject become pregnant during the study?
    text
    C0919624 (UMLS CUI [1])
    Pregnancy of a female partner of the male subject
    Code List
    Did a female partner of the male subject become pregnant during the study?
    CL Item
    No (No)
    CL Item
    Yes (Yes)
    CL Item
    Not applicable (Not applicable)
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    Pregnancy of the subject
    Code List
    Did the subject become pregnant during the study?
    CL Item
    No (No)
    CL Item
    Yes (Yes)
    Back to the top of the page 

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