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