Informações:
Falhas:
ID
19241
Descrição
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 Book 4/Visit 4.
Palavras-chave
Versões (3)
- 16/09/2016 16/09/2016 -
- 02/10/2016 02/10/2016 -
- 14/12/2016 14/12/2016 -
Transferido a
14 de dezembro de 2016
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
M.Alzheimer GSK - Book 4 NCT00334568/ GSK-AVA100193
M.Alzheimer GSK - Book 4NCT00334568/ GSK-AVA100193
- StudyEvent: ODM
Similar models
M.Alzheimer GSK - Book 4NCT00334568/ GSK-AVA100193
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Visit Description
Item
Visit Description: Visit 4
boolean
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Subject Continuation
Item
Subject Continuation (See Description)
boolean
C0805733 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood pressure: Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood pressure: Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Date samples taken
Item
Date samples taken
date
C1302413 (UMLS CUI [1])
Concomitant Medications
Item
Concomitant Medications
text
C2347852 (UMLS CUI [1])
Adverse Events
Item
Adverse Events
text
C0877248 (UMLS CUI [1])
Physical Examination
Item
Results from Physical Examination
text
C0031809 (UMLS CUI [1])
CL Item
< 1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
> 10 mm (5)
Code List
Indication which ankle was assessed at this visit
CL Item
Right ankle (1)
CL Item
Left ankle (2)
Item Group
Monitor Data Validation Checks
C1519941 (UMLS CUI-1)
C0030695 (UMLS CUI-2)
C0030695 (UMLS CUI-2)
Monitor Data Validation Checks
Item
Results from Monitor Data Validation Checks
text
C1519941 (UMLS CUI [1,1])
C0030695 (UMLS CUI [1,2])
C0030695 (UMLS CUI [1,2])
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
IP Container No.
Item
IP Container No.
integer
C0180098 (UMLS CUI [1])
Total Number of Tablets Dispensed
Item
Total Number of Tablets Dispensed
float
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Total Number of Tablets Returned
Item
Total Number of Tablets Returned
float
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
Next Visit Scheduled
Item
Next Visit Scheduled
boolean
C0515681 (UMLS CUI [1])