ID
19172
Beschrijving
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.
Trefwoorden
Versies (2)
- 03-10-16 03-10-16 -
- 09-12-16 09-12-16 -
Geüploaded op
9 december 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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M.Alzheimer GSK - Running LogsNCT00334568/ GSK-AVA100193
M.Alzheimer GSK - Running LogsNCT00334568/ GSK-AVA100193
- StudyEvent: ODM
Beschrijving
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Drug Name
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Total Daily Dose
Datatype
integer
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Ongoing Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Non-Serious Adverse Events (AE)
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-Serious Adverse Events
Datatype
text
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Outcome
Datatype
text
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Maximum Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beschrijving
Actions Taken due to Non-Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1822352
- UMLS CUI [1,2]
- C1518404
Beschrijving
Withdrawal
Datatype
boolean
Alias
- UMLS CUI [1]
- C2349954
Beschrijving
Relationship
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015608
Beschrijving
Serious Adverse Event (SAE) - General Information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1508263
Beschrijving
Protocol Identifier
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826693
Beschrijving
Subject Identifier
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Centre Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C0019994
Beschrijving
Randomization Number
Datatype
integer
Alias
- UMLS CUI [1]
- C2986235
Beschrijving
SAE
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious Adverse Event (SAE) - Section I
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Event
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
If fatal, record date of death.
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Maximum Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beschrijving
Action Taken with Investigational Product as a Result of the SAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1822352
- UMLS CUI [1,2]
- C1519255
Beschrijving
Withdrawal
Datatype
boolean
Alias
- UMLS CUI [1]
- C2349954
Beschrijving
Relationship to Investigational Product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
Beschrijving
Autopsy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschrijving
Serious Adverse Event (SAE) - Section II
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2348235
Beschrijving
Serious Adverse Event (SAE) - Section III Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1704791
Beschrijving
Serious Adverse Event (SAE) - Section IV
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event (SAE) - Section V
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Causes of SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1519255
Beschrijving
Specification of Other
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Beschrijving
Serious Adverse Event (SAE) - Section VI
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Medical Condition
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Beschrijving
Date of onset
Datatype
date
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Current Condition while SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Beschrijving
Date of Last Occurrence
Datatype
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Beschrijving
Serious Adverse Event (SAE) - Section VII
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event (SAE) - Section VIII - Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1519255
Beschrijving
Drug Name
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Dose
Datatype
integer
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Taken Prior to Study
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Ongoing Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
Serious Adverse Event (SAE) - Section IX
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event (SAE) - Section X
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event (SAE) - Section XI
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Narrative Remarks
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Investigator´s signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator´s name
Datatype
text
Alias
- UMLS CUI [1]
- C2361125
Beschrijving
Date of Report
Datatype
date
Alias
- UMLS CUI [1]
- C1302584
Similar models
M.Alzheimer GSK - Running LogsNCT00334568/ GSK-AVA100193
- StudyEvent: ODM
C0013227 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1508263 (UMLS CUI-2)
C0019994 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1704791 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])