Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

ID

22330

Descrição

A Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) on Cerebral Glucose Utilization and Cognition in Subjects With Mild to Moderate Alzheimer's Disease (AD) Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: 49653/461, This form is to be performed in Treatment Phase. Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1

Palavras-chave

G30.9

Adverse event

30/05/2017 30/05/2017 -

Transferido a

30 de maio de 2017

DOI

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Licença

Creative Commons BY-NC 3.0

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1 Formulários

StudyEvent: ODM
1. Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Adverse Event

Item Group

Adverse Event

C0877248 (UMLS CUI-1)

Diagnosis

Item

Adverse Event GSK Use

text

C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])

Onset Date/Time

Item

Onset Date/Time

datetime

C2985916 (UMLS CUI [1])

End Date/Time

Item

End Date/Time (if ongoing, please leave blank)

datetime

C3899266 (UMLS CUI [1])

Outcome

Item

Outcome

integer

C1705586 (UMLS CUI [1])

Outcome

Code List

Outcome

CL Item

Resolved (1)

CL Item

Ongoing (2)

Course

Item

Event Course

integer

C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])

Course

Code List

Event Course

CL Item

Intermittent (1)

CL Item

Constant (2)

Intensity

Item

Intensity (maximum)

integer

C0522510 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])

Intensity

Code List

Intensity (maximum)

CL Item

Mild (1)

CL Item

Moderate (3)

CL Item

Severe (3)

Action taken

Item

Action taken with Respect to Investigational Drug

integer

C0441472 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])

Action taken

Code List

Action taken with Respect to Investigational Drug

CL Item

None (1)

CL Item

Dose reduced (2)

CL Item

Dose increased (3)

CL Item

Drug interrupted/restarted (4)

CL Item

Drug stopped (5)

Relationship to Investigational Drug

Item

Relationship to Investigational Drug

integer

C0013230 (UMLS CUI [1])

trial procedures

Code List

Relationship to Investigational Drug

CL Item

Not related (1)

CL Item

Unlikely (2)

CL Item

Suspected (reasonable possibility) (3)

CL Item

Probable (4)

Corrective Therapy

Item

Corrective Therapy If ´Yes`, Please record on Concomitant Medication form.

boolean

C0087111 (UMLS CUI [1])

Withdrawal

Item

Was subject withdrawn due to this AE?

boolean

C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])

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Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148