Information:
Fel:
ID
17584
Beskrivning
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)
Nyckelord
Versioner (2)
- 2016-09-18 2016-09-18 -
- 2016-09-25 2016-09-25 -
Uppladdad den
25 september 2016
DOI
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Licens
Creative Commons BY-NC-ND 3.0
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REFLECT-1 Study Conclusion NCT00428090
REFLECT-1 Study Conclusion NCT00428090
- StudyEvent: ODM
Similar models
REFLECT-1 Study Conclusion NCT00428090
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Patient Study ID
Item
Subject Identifier
text
C2348585 (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])
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])
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)
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])
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])