ID

19962

Descrição

An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: AVA100468, Sponsor: GSK

Palavras-chave

Versões (2)
  1. 01/02/2017 01/02/2017 -
  2. 06/02/2017 06/02/2017 -
Transferido a

1 de fevereiro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Running Logs Non-Serious Adverse Events GSK-AVA100468 NCT00381238

Inglês

Running Logs Non-Serious Adverse Events GSK-AVA100468 NCT00381238

1 Formulários  
Non-Serious Adverse Event
Descrição

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Event (diagnosis only, otherwise sign/symptom)
Descrição

Event

Tipo de dados

text

Alias
UMLS CUI [1]
C0877248
Start Date
Descrição

Start Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0877248
Outcome
Descrição

Outcome

Tipo de dados

integer

Alias
UMLS CUI [1]
C1705586
End Date
Descrição

End Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0877248
Maximum Intensity
Descrição

Maximum Intensity

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action Taken with Investigational Product(s) as a Result of the Serious AE
Descrição

Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occured. Dose interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or post-dosing).

Tipo de dados

integer

Alias
UMLS CUI [1]
C1704758
Did the subject withdraw from study as a result of this AE?
Descrição

Withdrawal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrição

Relationship to investigational products

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
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Similar models

Running Logs Non-Serious Adverse Events GSK-AVA100468 NCT00381238

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Event
Item
Event (diagnosis only, otherwise sign/symptom)
text
C0877248 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Serious AE
integer
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the Serious AE
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
C2349954 (UMLS CUI [1])
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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