ID

25749

Descrição

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the NSAE form.

Palavras-chave

Versões (1)
  1. 17/09/2017 17/09/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

17 de setembro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Parkinsons Disease NSAE 101468/169 NCT00381472

Inglês

GSK Ropinirole in Patients Suffering from Parkinsons Disease NSAE 101468/169 NCT00381472

1 Formulários  
NON-SERIOUS ADVERSE EVENTS
Descrição

NON-SERIOUS ADVERSE EVENTS

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

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1518404
Event
Descrição

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de dados

text

Alias
UMLS CUI [1]
C1518404
Start Date
Descrição

Start date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Outcome
Descrição

Outcome

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
End Date
Descrição

End Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Intensity
Descrição

Maximum Intensity

Tipo de dados

integer

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

Action Taken with Investigational Product(s) as a Result of the Non-Serious AE

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Descrição

Withdrawal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrição

Relationship to Investigational Product(s)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
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Similar models

GSK Ropinirole in Patients Suffering from Parkinsons Disease NSAE 101468/169 NCT00381472

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
NON-SERIOUS ADVERSE EVENTS
C1518404 (UMLS CUI-1)
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study? If Yes, record details below.
boolean
C1518404 (UMLS CUI [1])
Event
Item
Event
text
C1518404 (UMLS CUI [1])
Start date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
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 [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1518404 (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 Non-Serious AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Code List
Action Taken with Investigational Product(s) as a Result of the Non-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
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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