ID
19172
Beschreibung
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.
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Versionen (2)
- 03.10.16 03.10.16 -
- 09.12.16 09.12.16 -
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9. Dezember 2016
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M.Alzheimer GSK - Running LogsNCT00334568/ GSK-AVA100193
M.Alzheimer GSK - Running LogsNCT00334568/ GSK-AVA100193
- StudyEvent: ODM
Beschreibung
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Drug Name
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Total Daily Dose
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Ongoing Medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Non-Serious Adverse Events (AE)
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Non-Serious Adverse Events
Datentyp
text
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Outcome
Datentyp
text
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
End Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Maximum Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beschreibung
Actions Taken due to Non-Serious Adverse Event
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1822352
- UMLS CUI [1,2]
- C1518404
Beschreibung
Withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349954
Beschreibung
Relationship
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015608
Beschreibung
Serious Adverse Event (SAE) - General Information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1508263
Beschreibung
Protocol Identifier
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826693
Beschreibung
Subject Identifier
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Centre Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C0019994
Beschreibung
Randomization Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986235
Beschreibung
SAE
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Serious Adverse Event (SAE) - Section I
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Event
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Outcome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
If fatal, record date of death.
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Maximum Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beschreibung
Action Taken with Investigational Product as a Result of the SAE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1822352
- UMLS CUI [1,2]
- C1519255
Beschreibung
Withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349954
Beschreibung
Relationship to Investigational Product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
Beschreibung
Autopsy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschreibung
Serious Adverse Event (SAE) - Section II
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2348235
Beschreibung
Serious Adverse Event (SAE) - Section III Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1704791
Beschreibung
Serious Adverse Event (SAE) - Section IV
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event (SAE) - Section V
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Causes of SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1519255
Beschreibung
Specification of Other
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Beschreibung
Serious Adverse Event (SAE) - Section VI
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Medical Condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Beschreibung
Date of onset
Datentyp
date
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
Current Condition while SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Beschreibung
Date of Last Occurrence
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Beschreibung
Serious Adverse Event (SAE) - Section VII
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event (SAE) - Section VIII - Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1519255
Beschreibung
Drug Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
Dose
Datentyp
integer
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Taken Prior to Study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Ongoing Medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Serious Adverse Event (SAE) - Section IX
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event (SAE) - Section X
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event (SAE) - Section XI
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Narrative Remarks
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Investigator´s signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator´s name
Datentyp
text
Alias
- UMLS CUI [1]
- C2361125
Beschreibung
Date of Report
Datentyp
date
Alias
- UMLS CUI [1]
- C1302584
Ähnliche Modelle
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])