ID

26501

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 Serious Adverse Event (SAE)

Palavras-chave

Versões (1)
  1. 18/10/2017 18/10/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

18 de outubro de 2017

DOI

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Licença

Creative Commons BY-NC-ND 3.0
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Serious Adverse Event (SAE) Ropinirole in Parkinson's Disease GSK 101468/196

Inglês

Serious Adverse Event (SAE) Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulários  
Patient Information
Descrição

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Number
Descrição

Patient Number

Tipo de dados

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Descrição

Centre Number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
PAREXEL Receipt Date
Descrição

Receipt Date

Tipo de dados

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Serious Adverse Event - Complete the SAE Pages. Please complete these pages fully and accurately as possible in order to minimise the time you spend dealing with data queries. If the SAE is still ongoing at the time of reporting, please leave 'Event Course' blank and update it later. Sign and date the SAE page. Please ensure that all of the information on the following CRF pages is complete (Demography, significant Medical/Surgical History and Physiology Examination, Study Medication Record, Concomitant Medication, Form D (if applicable). Photocophy the SAE pages and the CRF pages specified above (Do not separate the NCR pages). Fax a copy of the SAE pages and all of the CRF pages specified above to: Your local GSK CRA/Medical Monitor (see Investigator Site File for appropriate fax number). If no photocopier OR fax is available please telephone your local GSK CRA/Medical monitor within 24 hours.
Descrição

Serious Adverse Event - Complete the SAE Pages. Please complete these pages fully and accurately as possible in order to minimise the time you spend dealing with data queries. If the SAE is still ongoing at the time of reporting, please leave 'Event Course' blank and update it later. Sign and date the SAE page. Please ensure that all of the information on the following CRF pages is complete (Demography, significant Medical/Surgical History and Physiology Examination, Study Medication Record, Concomitant Medication, Form D (if applicable). Photocophy the SAE pages and the CRF pages specified above (Do not separate the NCR pages). Fax a copy of the SAE pages and all of the CRF pages specified above to: Your local GSK CRA/Medical Monitor (see Investigator Site File for appropriate fax number). If no photocopier OR fax is available please telephone your local GSK CRA/Medical monitor within 24 hours.

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Descrição

Investigator's Name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
AEGIS Number
Descrição

Number

Tipo de dados

text

Alias
UMLS CUI [1]
C0237753
Serious Adverse Event
Descrição

Serious Adverse Event

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
Specify reason(s) for considering this a serious AE. Mark all that apply.
Descrição

Reason

Tipo de dados

integer

Alias
UMLS CUI [1]
C0566251
Onset Date
Descrição

Onset Date

Tipo de dados

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0574845
dd-mmm-yyyy
Onset Time
Descrição

Onset Time

Tipo de dados

time

Unidades de medida
  • 24hr:min
Alias
UMLS CUI [1]
C0449244
24hr:min
End Date (If ongoing please leave blank)
Descrição

End Date

Tipo de dados

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
End Time (If ongoing please leave blank)
Descrição

End Time

Tipo de dados

time

Unidades de medida
  • 24hr:min
24hr:min
Outcome
Descrição

If patient died, please complete Patient Death form)

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Event Course
Descrição

Event Course

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Event Course If Intermittent, specify No. of episodes
Descrição

Number of Episodes

Tipo de dados

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Descrição

Intensity

Tipo de dados

text

Alias
UMLS CUI [1]
C1710066
Action Taken with Respect to Investigational Drug
Descrição

Action taken

Tipo de dados

text

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Descrição

Relationship

Tipo de dados

text

Alias
UMLS CUI [1]
C0439849
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with:
Descrição

Assessment

Tipo de dados

text

Alias
UMLS CUI [1]
C0220825
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with: Please specify
Descrição

Assessment Specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C2348235
Corrective Therapy
Descrição

If 'YES', record details in the Concomitant Medication Section

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this AE?
Descrição

Withdrawal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Did the SAE ablate?
Descrição

Ablation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0547070
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
Descrição

Retreatment with study medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0376495
UMLS CUI [1,2]
C0304229
If 'YES', did SAE recur?
Descrição

Recurrence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0034897
Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)
Descrição

Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0587081
Test
Descrição

Laboratory Test

Tipo de dados

text

Alias
UMLS CUI [1]
C0022885
Date
Descrição

Laboratory Test Date

Tipo de dados

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2826641
dd-mmm-yyyy
Value
Descrição

Laboratory Value

Tipo de dados

text

Alias
UMLS CUI [1]
C0587081
Units
Descrição

Measurement Unit

Tipo de dados

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Descrição

Normal Range

Tipo de dados

text

Alias
UMLS CUI [1]
C0086715
Remarks (Please provide a brief narrative description of the SAE, attaching extra eg. hospital discharge summary if necessary)
Descrição

Remarks

Tipo de dados

text

If applicable, was randomisation code broken at investigational site?
Descrição

Randomization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0034656
Randomisation/Study Medication Number:
Descrição

Randomization Number

Tipo de dados

float

Alias
UMLS CUI [1]
C2986235
Investigator's Signature (confirming that the above data are accurate and complete)
Descrição

Investigator's Name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Date
Descrição

Date of Report

Tipo de dados

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1302584
dd-mmm-yyyy
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Similar models

Serious Adverse Event (SAE) 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 Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Receipt Date
Item
PAREXEL Receipt Date
date
C1320303 (UMLS CUI [1])
Item Group
Serious Adverse Event - Complete the SAE Pages. Please complete these pages fully and accurately as possible in order to minimise the time you spend dealing with data queries. If the SAE is still ongoing at the time of reporting, please leave 'Event Course' blank and update it later. Sign and date the SAE page. Please ensure that all of the information on the following CRF pages is complete (Demography, significant Medical/Surgical History and Physiology Examination, Study Medication Record, Concomitant Medication, Form D (if applicable). Photocophy the SAE pages and the CRF pages specified above (Do not separate the NCR pages). Fax a copy of the SAE pages and all of the CRF pages specified above to: Your local GSK CRA/Medical Monitor (see Investigator Site File for appropriate fax number). If no photocopier OR fax is available please telephone your local GSK CRA/Medical monitor within 24 hours.
C1519255 (UMLS CUI-1)
Investigator's Name
Item
Person Reporting SAE
text
C2826892 (UMLS CUI [1])
Number
Item
AEGIS Number
text
C0237753 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
integer
C0566251 (UMLS CUI [1])
Reason
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
fatal (1)
CL Item
life threatening (2)
CL Item
disabling/incapacitating (3)
CL Item
requires hospitalization (excluding elective surgery or routine clinical procedures) (4)
CL Item
hospitalization prolonged (5)
CL Item
congenital anomaly (6)
CL Item
cancer (7)
CL Item
overdose (8)
CL Item
Investigator considers serious or a significant hazard, contraindication, side effect or precaution (9)
CL Item
pregnancy (10)
Onset Date
Item
Onset Date
date
C0574845 (UMLS CUI [1])
Onset Time
Item
Onset Time
time
C0449244 (UMLS CUI [1])
End Date
Item
End Date (If ongoing please leave blank)
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time (If ongoing please leave blank)
time
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died (Died)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
Number of Episodes
Item
Event Course If Intermittent, specify No. of episodes
float
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Action Taken with Respect to Investigational Drug
text
C2826626 (UMLS CUI [1])
action taken
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (Dose increased)
CL Item
Dose reduced (Dose reduced)
CL Item
Drug interrupted/restarted (Drug interrupted/restarted)
CL Item
Drug stopped (Drug stopped)
CL Item
None (None)
Item
Relationship to Investigational Drug
text
C0439849 (UMLS CUI [1])
Relationship
Code List
Relationship to Investigational Drug
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (reasonable possibility) (Suspected (reasonable possibility))
CL Item
Probable (Probable)
Item
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with:
text
C0220825 (UMLS CUI [1])
Assessment
Code List
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with:
CL Item
Protocol design or procedures (Protocol design or procedures)
CL Item
Another condition (e.g., condition under study, intercurrent illness) (Another condition (e.g., condition under study, intercurrent illness))
CL Item
Another drug (Another drug)
Assessment Specification
Item
Relationship to Investigational Drug: If 'Not related', 'Unlikely', The SAE is probably associated with: Please specify
text
C0220825 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal
Item
Was subject withdrawn due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Ablation
Item
Did the SAE ablate?
boolean
C0547070 (UMLS CUI [1])
Retreatment with study medication
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0376495 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Recurrence
Item
If 'YES', did SAE recur?
boolean
C0034897 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)
C1519255 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
Laboratory Test
Item
Test
text
C0022885 (UMLS CUI [1])
Laboratory Test Date
Item
Date
date
C2826641 (UMLS CUI [1])
Laboratory Value
Item
Value
text
C0587081 (UMLS CUI [1])
Measurement Unit
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
Remarks
Item
Remarks (Please provide a brief narrative description of the SAE, attaching extra eg. hospital discharge summary if necessary)
text
Randomization
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1])
Randomization Number
Item
Randomisation/Study Medication Number:
float
C2986235 (UMLS CUI [1])
Investigator's Name
Item
Investigator's Signature (confirming that the above data are accurate and complete)
text
C2826892 (UMLS CUI [1])
Date of Report
Item
Date
date
C1302584 (UMLS CUI [1])
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