ID

17584

Description

NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

Mots-clés

  1. 18/09/2016 18/09/2016 -
  2. 25/09/2016 25/09/2016 -
Téléchargé le

25 septembre 2016

DOI

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Licence

Creative Commons BY-NC-ND 3.0

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    REFLECT-1 Study Conclusion NCT00428090

    REFLECT-1 Study Conclusion NCT00428090

    Patient Information
    Description

    Patient Information

    Alias
    UMLS CUI-1
    C1955348
    Subject Identifier
    Description

    Patient Study ID

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    Did the subject become pregnant during the study? (Check that responses provided correspond with the sex of the subject) If "Yes", complete Pregnancy Notification
    Description

    Pregnancy Information

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0032961
    Study Conclusion - Investigator Instructions: Refer to protocol selection(s) (insert protocol section number(s)) to evaluate subject completion or withdrawal from the study.
    Description

    Study Conclusion - Investigator Instructions: Refer to protocol selection(s) (insert protocol section number(s)) to evaluate subject completion or withdrawal from the study.

    Alias
    UMLS CUI-1
    C1707478
    Date of subject completion or withdrawal: - If subject completed study: Date of subject completion or withdrawal must match the last scheduled study visit date. - If subject withdrew and a withdrawal visit was conducted: Date of subject completion or withdrawal must match the date of subject withdrawal. - If subject is lost to follow-up: Date of subject completion is or withdrawal must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. (Note: An "Actual contact" is defined as an interaction between the subject and the investigator or investigator's designee, where the investigator/designee has the opportunity to querry the subject about the subject's status. This would include clinic visits and telephone contacts, but nomally would not include mail correspondence or third party reports.)
    Description

    Study End Date

    Type de données

    date

    Unités de mesure
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1]
    C2983670
    dd/MMM/yyyy
    Was the subject withdrawn from the study?
    Description

    Study Withdrawal

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3640719
    Was the subject withdrawn from the study? If "Yes", tick the primary reason for withdrawal: (Note: - Adverse Event: includes adverse events, serious adverse events, death (see protocol section 10) - Protocol violation: includes use of prohibited/conditional medications (see protocol section 8.2) - Subject decided to withdraw from the study: includes caregiver decision to withdraw the subject) -Non-compliance: includes non-compliance with study medication (see protocol section 7.11), or with study visits/ procedures.)
    Description

    Study Withdrawal Specification

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C3640719
    UMLS CUI [1,2]
    C2348235
    Was the subject withdrawn from the study? If "Yes", tick the primary reason for withdrawal: If "Other", specify:
    Description

    Study Withdrawal Other Reason

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C3640719
    UMLS CUI [1,2]
    C3840932
    Identification and Signature (A medically qualified Sub-investigator may sign this page; however, the investigator remains accountable for CRF data.)
    Description

    Identification and Signature (A medically qualified Sub-investigator may sign this page; however, the investigator remains accountable for CRF data.)

    Alias
    UMLS CUI-1
    C0205396
    UMLS CUI-2
    C1519316
    Date of report
    Description

    Date of report

    Type de données

    date

    Unités de mesure
    • dd/MMM/yy
    Alias
    UMLS CUI [1]
    C1302584
    dd/MMM/yy
    Investigator's Name
    Description

    Investigator's Name

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0027365
    Investigator's signature ("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 the date below.")
    Description

    Investigator's signature

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2346576

    Similar models

    REFLECT-1 Study Conclusion NCT00428090

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Patient Information
    C1955348 (UMLS CUI-1)
    Patient Study ID
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    Item
    Did the subject become pregnant during the study? (Check that responses provided correspond with the sex of the subject) If "Yes", complete Pregnancy Notification
    text
    C0032961 (UMLS CUI [1])
    Code List
    Did the subject become pregnant during the study? (Check that responses provided correspond with the sex of the subject) If "Yes", complete Pregnancy Notification
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Not Applicable (not of childbearing potential or male) (Not Applicable (not of childbearing potential or male))
    Item Group
    Study Conclusion - Investigator Instructions: Refer to protocol selection(s) (insert protocol section number(s)) to evaluate subject completion or withdrawal from the study.
    C1707478 (UMLS CUI-1)
    Study End Date
    Item
    Date of subject completion or withdrawal: - If subject completed study: Date of subject completion or withdrawal must match the last scheduled study visit date. - If subject withdrew and a withdrawal visit was conducted: Date of subject completion or withdrawal must match the date of subject withdrawal. - If subject is lost to follow-up: Date of subject completion is or withdrawal must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. (Note: An "Actual contact" is defined as an interaction between the subject and the investigator or investigator's designee, where the investigator/designee has the opportunity to querry the subject about the subject's status. This would include clinic visits and telephone contacts, but nomally would not include mail correspondence or third party reports.)
    date
    C2983670 (UMLS CUI [1])
    Study Withdrawal
    Item
    Was the subject withdrawn from the study?
    boolean
    C3640719 (UMLS CUI [1])
    Item
    Was the subject withdrawn from the study? If "Yes", tick the primary reason for withdrawal: (Note: - Adverse Event: includes adverse events, serious adverse events, death (see protocol section 10) - Protocol violation: includes use of prohibited/conditional medications (see protocol section 8.2) - Subject decided to withdraw from the study: includes caregiver decision to withdraw the subject) -Non-compliance: includes non-compliance with study medication (see protocol section 7.11), or with study visits/ procedures.)
    text
    C3640719 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Code List
    Was the subject withdrawn from the study? If "Yes", tick the primary reason for withdrawal: (Note: - Adverse Event: includes adverse events, serious adverse events, death (see protocol section 10) - Protocol violation: includes use of prohibited/conditional medications (see protocol section 8.2) - Subject decided to withdraw from the study: includes caregiver decision to withdraw the subject) -Non-compliance: includes non-compliance with study medication (see protocol section 7.11), or with study visits/ procedures.)
    CL Item
    Adverse Event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropiate) (Adverse Event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropiate))
    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
    Non-compliance (Non-compliance)
    CL Item
    Other (Other)
    Item
    Was the subject withdrawn from the study? If "Yes", tick the primary reason for withdrawal: If "Other", specify:
    text
    C3640719 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Code List
    Was the subject withdrawn from the study? If "Yes", tick the primary reason for withdrawal: If "Other", specify:
    Item Group
    Identification and Signature (A medically qualified Sub-investigator may sign this page; however, the investigator remains accountable for CRF data.)
    C0205396 (UMLS CUI-1)
    C1519316 (UMLS CUI-2)
    Date of report
    Item
    Date of report
    date
    C1302584 (UMLS CUI [1])
    Investigator's Name
    Item
    Investigator's Name
    text
    C2346576 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])
    Investigator's signature
    Item
    Investigator's signature ("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 the date below.")
    text
    C2346576 (UMLS CUI [1])

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