Informações:
Falhas:
ID
24367
Descrição
Study part: Non-Serious Adverse Events.Study part: .An Open-Label Extension phase 3 Study with REQUIP (ropinirole) CR for Subjects from Studies 101468/165, 101468/168 and 101468/169 Patient Level Data. Study ID:101468/248, Clinical Study ID: 101468/248.
Palavras-chave
Versões (1)
- 30/07/2017 30/07/2017 -
Titular dos direitos
GlaxoSmithKline
Transferido a
30 de julho de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Non-Serious Adverse Events Ropinirole NCT00632736
Non-Serious Adverse Events
- StudyEvent: ODM
Similar models
Non-Serious Adverse Events
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-Serious Adverse Events
Item
Event
text
C1518404 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C2826626 (UMLS CUI [1])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
subject withdraw from study as a result of AE
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Causations Adverse event
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])
C0877248 (UMLS CUI [1,2])