ID
17785
Description
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK. This ODM contains the Running Logs.
Keywords
Versions (2)
- 10/3/16 10/3/16 -
- 12/9/16 12/9/16 -
Uploaded on
October 3, 2016
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Running Logs
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Running Logs
- StudyEvent: ODM
Description
Concomitant Medications
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Total Daily Dose
Data type
integer
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Route
Data type
text
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Start Date
Data type
date
Description
Stop Date
Data type
date
Description
Ongoing Medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Non-Serious Adverse Events (AE)
Description
Event
Data type
text
Description
Start Date
Data type
date
Description
Outcome
Data type
text
Description
End Date
Data type
date
Description
Maximum Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Description
Actions Taken with Investigational Product(s) as a Result of the Non-Serious AE
Data type
text
Description
Withdrawal
Data type
boolean
Description
Relationship to Investigational Product(s)
Data type
boolean
Description
Serious Adverse Event (SAE) - General Information
Description
Protocol Identifier
Data type
boolean
Description
Subject Identifier
Data type
integer
Description
Centre/Investigation Number
Data type
integer
Description
Randomization Number
Data type
integer
Description
SAE
Data type
boolean
Description
Serious Adverse Event (SAE) - Section I
Description
Event
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Start Date
Data type
date
Description
Outcome
Data type
integer
Description
If fatal, record date of death.
Data type
date
Description
Maximum Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Description
Action Taken with Investigational Product as a Result of the SAE
Data type
integer
Description
Withdrawal
Data type
boolean
Description
Relationship to Investigational Product
Data type
boolean
Description
Autopsy
Data type
boolean
Alias
- UMLS CUI [1]
- C0004398
Description
Serious Adverse Event (SAE) - Section II
Description
Serious Adverse Event (SAE) - Section III Demography Data
Description
Serious Adverse Event (SAE) - Section IV
Description
Serious Adverse Event (SAE) - Section V
Description
Possible Causes of SAE Other Than Investigational Product(s)
Data type
text
Description
Specification of Other
Data type
text
Description
Serious Adverse Event (SAE) - Section VI
Description
Medical Condition
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Description
Date of onset
Data type
date
Alias
- UMLS CUI [1]
- C0574845
Description
Current Condition while SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Description
If No, Date of Last Occurrence
Data type
date
Description
Serious Adverse Event (SAE) - Section VII
Description
Serious Adverse Event (SAE) - Section VIII - Relevant Concomitant Medications
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Dose (e.g 150)
Data type
integer
Description
Unit (e.g ml)
Data type
text
Description
Frequency (e.g BID)
Data type
text
Description
Route (e.g PO)
Data type
text
Description
Taken Prior to Study?
Data type
boolean
Description
Start Date
Data type
date
Description
Stop Date
Data type
date
Description
Ongoing Medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Serious Adverse Event (SAE) - Section IX
Description
Serious Adverse Event (SAE) - Section X
Description
Serious Adverse Event (SAE) - Section XI
Description
Narrative Remarks
Data type
text
Description
Investigator´s signature
Data type
text
Description
Investigator´s name (print)
Data type
text
Description
Date
Data type
date
Similar models
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Running Logs
- StudyEvent: ODM
C0013227 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])