ID

22173

Descrição

This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease. GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1

Palavras-chave

  1. 09/05/2017 09/05/2017 -
  2. 22/05/2017 22/05/2017 -
Transferido a

22 de maio de 2017

DOI

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Licença

Creative Commons BY-NC 3.0

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Non-Serious Adverse Events (AE) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238

Non-Serious Adverse Events (AE) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238

Non-Serious Adverse Event
Descrição

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study? If YES, record details below.
Descrição

Non serious adverse event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Events (AE)
Descrição

Non-Serious Adverse Events (AE)

Alias
UMLS CUI-1
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Headache
Descrição

Non-Serious Adverse Event

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
Start Date (Day Month Year) (e.g. 25 JAN 03)
Descrição

Start Date

Tipo de dados

date

Unidades de medida
  • dd/MMM/yy
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
dd/MMM/yy
Start time (e.g. 13:25)
Descrição

Start time

Tipo de dados

time

Unidades de medida
  • hr:min
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
hr:min
Outcome
Descrição

Outcome

Tipo de dados

integer

Alias
UMLS CUI [1]
C1705586
End Date e.g. 27 Jan 03
Descrição

End Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
End Time e.g. 10:20
Descrição

End Time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Frequency
Descrição

Frequency

Tipo de dados

integer

Alias
UMLS CUI [1]
C3476109
Maximum Intensity
Descrição

Maximum Intensity

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Descrição

Action Taken with Investigational Product

Tipo de dados

integer

Alias
UMLS CUI [1]
C1704758
Withdrawal
Descrição

Withdrawal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1518404
Relationship to Investigational Product(s) Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrição

Relationship to Investigational Product

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0085978

Similar models

Non-Serious Adverse Events (AE) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Non serious adverse event
Item
Did the subject experience any non-serious adverse events during the study? If YES, record details below.
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events (AE)
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Headache
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Start Date
Item
Start Date (Day Month Year) (e.g. 25 JAN 03)
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time
Item
Start time (e.g. 13:25)
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Code List
Outcome
CL Item
Single episode (1)
CL Item
Intermittent (2)
End Date
Item
End Date e.g. 27 Jan 03
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time
Item
End Time e.g. 10:20
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C1704758 (UMLS CUI [1])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Single episode (1)
CL Item
Intermittent (2)
Withdrawal
Item
Withdrawal
boolean
C2349954 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])

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