ID

25749

Beschrijving

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.

Trefwoorden

Versies (1)
  1. 17-09-17 17-09-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 september 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

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

1 Formulieren  
NON-SERIOUS ADVERSE EVENTS
Beschrijving

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.
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

Alias
UMLS CUI [1]
C1518404
Start Date
Beschrijving

Start date

Datatype

date

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

Outcome

Datatype

integer

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

End Date

Datatype

date

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

Maximum Intensity

Datatype

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
Beschrijving

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

Datatype

integer

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

Withdrawal

Datatype

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?
Beschrijving

Relationship to Investigational Product(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial