ID

26274

Descrição

Study ID: 101468/196 Clinical Study ID: 101468/196 Study Title: 101468/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00650104 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 DiseaseA Long-Term, Open-Label Continuation Study of Once Daily Adminstration of Ropinirole CR Tablets to Patients with Parkinson's Disease Who Completed the Previous Ropinirole CR Studies - 167 & 164 Ongoing Record: Adverse Events

Palavras-chave

Versões (1)
  1. 15/10/2017 15/10/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

15 de outubro de 2017

DOI

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Licença

Creative Commons BY-NC-ND 3.0
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Adverse Events Ropinirole in Parkinson's Disease GSK 101468/196

Inglês

Adverse Events Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulários  
Patient Information
Descrição

Patient Information

Alias
UMLS CUI-1
C1955348
Patient No.
Descrição

Patient Number

Tipo de dados

text

Alias
UMLS CUI [1]
C1830427
Adverse Events
Descrição

Adverse Events

Alias
UMLS CUI-1
C0877248
Has the patient experienced any new and/or worsening adverse events from the time of Study 196 Completion Visit through the end of the Treatment Period? This CRF will only be used by subjects who have re-enrolled in the study after completion at 36 months. Other subjects (who didn't have to re-enroll) can continus using original CRFs.
Descrição

If YES, indicate below.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0877248
Adverse Event:
Descrição

Adverse Event Diagnosis

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
Adverse Event: Serious?*
Descrição

* A Serious Adverse Event is any AE that is fatal, life-threatening , disabling/incapacitating, results in inpatient hospitalization or prolongation of existing hospitalization, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgement, they may jeopardise the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Cancer, overdose and pregnancy must also be reported on SAE form. Record any Serious Adverse Events on the Serious Adverse Event from and notify the PAREXEL Clinical Trial Safety Center within 24 hours of learning of its occurence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1710056
Start Date
Descrição

Start Date

Tipo de dados

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0808070
dd-mmm-yyyy
Start Time
Descrição

Start Time

Tipo de dados

time

Unidades de medida
  • 24hr:min
Alias
UMLS CUI [1]
C1301880
24hr:min
Stop Date
Descrição

If ongoing, please eave blank.

Tipo de dados

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
Stop Time
Descrição

End Time

Tipo de dados

time

Unidades de medida
  • 24hr:min
Alias
UMLS CUI [1]
C1522314
24hr:min
Intensity (tick only one)
Descrição

Adverse Event: Intensity

Tipo de dados

integer

Alias
UMLS CUI [1]
C1710066
Relationship to Drug (tick only one)
Descrição

Relationship to Drug

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Action Taken (tick only one)
Descrição

Action Taken

Tipo de dados

integer

Alias
UMLS CUI [1]
C2826626
Corrective Therapy
Descrição

If YES, record on Other (non-study) Medications Form.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Event Course (tick only one)
Descrição

Event Course

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Event Course: If INTERMITTENT; record number of episodes:
Descrição

Number of Adverse Events

Tipo de dados

float

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Outcome (tick only one)
Descrição

Adverse Event Outcome

Tipo de dados

integer

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Similar models

Adverse Events Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Number
Item
Patient No.
text
C1830427 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Adverse Event
Item
Has the patient experienced any new and/or worsening adverse events from the time of Study 196 Completion Visit through the end of the Treatment Period? This CRF will only be used by subjects who have re-enrolled in the study after completion at 36 months. Other subjects (who didn't have to re-enroll) can continus using original CRFs.
boolean
C0877248 (UMLS CUI [1])
Adverse Event Diagnosis
Item
Adverse Event:
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Seriousness of Adverse Event
Item
Adverse Event: Serious?*
boolean
C1710056 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
End Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
End Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Item
Intensity (tick only one)
integer
C1710066 (UMLS CUI [1])
Adverse Event: Intensity
Code List
Intensity (tick only one)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to Drug (tick only one)
integer
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Drug
Code List
Relationship to Drug (tick only one)
CL Item
Not Related (1)
CL Item
Unlikely (2)
CL Item
Suspected (reasonable possibility) (3)
CL Item
Probable (4)
Item
Action Taken (tick only one)
integer
C2826626 (UMLS CUI [1])
Action Taken
Code List
Action Taken (tick only one)
CL Item
None (1)
CL Item
Dose Reduced (2)
CL Item
Dose Increased (3)
CL Item
Drug Interruped/Restarted (4)
CL Item
Drug Stopped (5)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Event Course (tick only one)
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course (tick only one)
CL Item
Intermittent (1)
CL Item
Constant (2)
Number of Adverse Events
Item
Event Course: If INTERMITTENT; record number of episodes:
float
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item
Outcome (tick only one)
integer
Adverse Event Outcome
Code List
Outcome (tick only one)
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Resolved with Sequelae (3)
CL Item
Died (4)
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