0 Ratings
ID

34864

Description

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders This form contains the conclusion of the study, it should be filled out at the final visit.

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Versions (2)
  1. 1/26/19 1/26/19 -
  2. 2/1/19 2/1/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 1, 2019

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License

Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

    English

    Study Conclusion

    1 forms  
    1. StudyEvent: ODM
      1. Study Conclusion
    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 subject completion or withdrawal
    Description

    Date of Completion or Withdrawal

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0422727
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Was the subject withdrawn from the study?
    Description

    If Yes, tick the primary reason for withdrawal

    Data type

    text

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

    Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. If subject did not meet treatment eligibility criteria, ensure ’Clinically significant screening lab values’ and/or ’Clinically significant screening ECG abnormalities’ are ticked.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008976
    Other, specify
    Description

    Other Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [2,1]
    C2349954
    UMLS CUI [2,2]
    C0392360
    UMLS CUI [2,3]
    C0008976
    Investigator Comment Log
    Description

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C0947611
    CRF Page Number if Applicable
    Description

    CRF Page Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C1516308
    Comment
    Description

    Only use this form to record explanatory information on anomalies such as missing data, sponsor waiver of inclusion/exclusion criteria, departures from planned investigational product administration or missed visits.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Signature
    Description

    Signature

    Alias
    UMLS CUI-1
    C1519316
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
    Description

    The Investigator is accountable for CRF data. However, the Principal Investigator may delegate CRF signature authority to a medically qualified Sub-investigator (as indicated on the Site Staff Signature Sheet).

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Investigator's Name (print)
    Description

    Investigator's Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    Study Conclusion

    1 forms
    1. StudyEvent: ODM
      1. Study Conclusion
    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 Completion or Withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C0422727 (UMLS CUI [2,2])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Item
    Was the subject withdrawn from the study?
    text
    C0422727 (UMLS CUI [1])
    Subject Withdrawal
    Code List
    Was the subject withdrawn from the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If Yes, tick the primary reason for withdrawal:
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Reason for Withdrawal
    Code List
    If Yes, tick the primary reason for withdrawal:
    CL Item
    Adverse event (Adverse event)
    CL Item
    Lost to follow-up (Lost to follow-up)
    CL Item
    Protocol violation (Protocol violation)
    CL Item
    Subject decided to withdraw from the study (Subject decided to withdraw from the study)
    CL Item
    Sponsor terminated study (Sponsor terminated study)
    CL Item
    Subject did not have opportunity to treat migraine (Subject did not have opportunity to treat migraine)
    CL Item
    Did not meet treatment eligibility criteria (Did not meet treatment eligibility criteria)
    CL Item
    Clinically significant screening lab values (Clinically significant screening lab values)
    CL Item
    Clinically significant screening ECG abnormalities (Clinically significant screening ECG abnormalities)
    CL Item
    Other (Other)
    Other Specification
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [2,1])
    C0392360 (UMLS CUI [2,2])
    C0008976 (UMLS CUI [2,3])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    CRF Page Number
    Item
    CRF Page Number if Applicable
    text
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Signature
    C1519316 (UMLS CUI-1)
    Investigator's Signature
    Item
    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
    text
    C2346576 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Investigator's Name
    Item
    Investigator's Name (print)
    text
    C2826892 (UMLS CUI [1])
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