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26226
Beschrijving
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 Follow-Up
Trefwoorden
Versies (1)
- 12-10-17 12-10-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
12 oktober 2017
DOI
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Licentie
Creative Commons BY-NC-ND 3.0
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Follow-Up Ropinirole in Parkinson's Disease GSK 101468/196
Follow-Up Ropinirole in Parkinson's Disease GSK 101468/196
- StudyEvent: ODM
Similar models
Follow-Up Ropinirole in Parkinson's Disease GSK 101468/196
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient Number
Item
Patient No.
text
C1830427 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Time of Examination
Item
Time Point (Time [24-hour clock])
time
C0040223 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
Semi-Supine Heart Rate
Item
Semi-Supine Heart Rate
float
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Erect Heart Rate
Item
Standing Heart Rate
float
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Semi-Supine Systolic Blood Pressure
Item
Semi-Supine Systolic Blood Pressure
float
C0871470 (UMLS CUI [1])
Semi-Supine Diastolic Blood Pressure
Item
Semi-Supine Diastolic Blood Pressure
float
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
Erect Systolic Blood Pressure
Item
Standing Systolic Blood Pressure
float
C0522014 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
Erect Diastolic Blood Pressure
Item
Standing Diastolic Blood Pressure
float
C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
Dispensed Amount
Item
Total number of tablets dispensed at last visit.
text
C0805077 (UMLS CUI [1])
Returned Amount
Item
Total Number of tablets returned at visit.
text
C2699071 (UMLS CUI [1])
Compliance
Item
Number of tablets patient should have taken (assuming 100% compliance).
text
C1321605 (UMLS CUI [1])
Missed Dose: Date
Item
If there were missed doses, please record. Date
date
C1709043 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Missed Dose: Tablet
Item
If there were missed doses, please record. Tablet(s)
text
C1709043 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Missed Dose: Dosage
Item
If there were missed doses, please record. Dose in mg
float
C1709043 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Missed Dose: Reason
Item
If there were missed doses, please record. Reason
text
C1709043 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (male or female not of childbearing potential) (3)
Item
If YES, what type of pregnancy was performed?
integer
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Serum (1)
CL Item
Urine (2)
Date of Pregnancy Test
Item
If YES, Date of Test:
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Completion of Dosing Period
C0805732 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0178602 (UMLS CUI-2)
Competion of maintenance period
Item
Did the patient complete the maintenance period?
boolean
C0805732 (UMLS CUI [1,1])
C0677908 (UMLS CUI [1,2])
C0677908 (UMLS CUI [1,2])
Item
If the answer to the question is NO, check the one most significant reason below. Adverse Event
integer
C0877248 (UMLS CUI [1])
Code List
If the answer to the question is NO, check the one most significant reason below. Adverse Event
CL Item
Adverse Event (1)
Adverse Event: Specification
Item
If the answer to the question is NO, check the one most significant reason below. Adverse event, specify:
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
If the answer to the question is NO, check the one most significant reason below. Patient Request.
integer
C0332153 (UMLS CUI [1])
Code List
If the answer to the question is NO, check the one most significant reason below. Patient Request.
CL Item
Patient request (unrelated to AE) (2)
Patient Request: Specification
Item
If the answer to the question is NO, check the one most significant reason below. Patient request (unrelated to an AE), specify:
text
C0332153 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
If the answer to the question is NO, check the one most significant reason below. Non-compliance.
integer
C1321605 (UMLS CUI [1])
Code List
If the answer to the question is NO, check the one most significant reason below. Non-compliance.
CL Item
Non-compliance (unrelated to an AE) (3)
Compliance: Specification
Item
If the answer to the question is NO, check the one most significant reason below. Non-compliance (unrelated to an AE), specify:
text
C1321605 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
If the answer to the question is NO, check the one most significant reason below. Investigator judgement.
integer
C0022423 (UMLS CUI [1])
Code List
If the answer to the question is NO, check the one most significant reason below. Investigator judgement.
CL Item
Investigator judgement (4)
Judgement: Specification
Item
If the answer to the question is NO, check the one most significant reason below. Investigator judgement, specify:
text
C0022423 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
If the answer to the question is NO, check the one most significant reason below. Termination of patient dosing by sponsor.
integer
C0871548 (UMLS CUI [1])
Code List
If the answer to the question is NO, check the one most significant reason below. Termination of patient dosing by sponsor.
CL Item
Termination of patient dosing by sponsor (5)
Item
If the answer to the question is NO, check the one most significant reason below. Protocol Violation.
integer
C1709750 (UMLS CUI [1])
Code List
If the answer to the question is NO, check the one most significant reason below. Protocol Violation.
CL Item
Protocol violation (6)
Protocol Violation: Specification
Item
If the answer to the question is NO, check the one most significant reason below. Protocol violation, specify:
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
If the answer to the question is NO, check the one most significant reason below. Death; complete the Patient Death CRF.
integer
C0011065 (UMLS CUI [1])
Code List
If the answer to the question is NO, check the one most significant reason below. Death; complete the Patient Death CRF.
CL Item
Death; complete the Patient Death CRF (7)
Item
If the answer to the question is NO, check the one most significant reason below. Other.
integer
C3840932 (UMLS CUI [1])
Code List
If the answer to the question is NO, check the one most significant reason below. Other.
CL Item
Other (8)
Other Reason: Specification
Item
If the answer to the question is NO, check the one most significant reason below. Other, specify:
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
End Date
Item
Date of study termination (last protocol assessment):
date
C0806020 (UMLS CUI [1])
Last Dosage
Item
Last dose in maintenance period:
float
C0178602 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
Date of Last Dose
Item
Date of last dose in maintenance period:
date
C1762893 (UMLS CUI [1])
Down Titration
Item
Was the patient down-titrated for 1 week?
boolean
C2983683 (UMLS CUI [1,1])
C0205216 (UMLS CUI [1,2])
C0205216 (UMLS CUI [1,2])
Down Titration: Reason
Item
Was the patient down-titrated for 1 week? If NO, please specify reason:
text
C2983683 (UMLS CUI [1,1])
C0205216 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205216 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Down Titration: Duration
Item
Was the patient down-titrated for 1 week? If NO, specify duration of Down Titrationn:
text
C2983683 (UMLS CUI [1,1])
C0205216 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0205216 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Down Titration: Last Dosage
Item
Last dose in Down-Titration:
float
C2983683 (UMLS CUI [1,1])
C0205216 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0205216 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Down Titration: Date of Last Dose
Item
Date of last Down-Titration Dose:
date
C2983683 (UMLS CUI [1,1])
C0205216 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
C0205216 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
Investigator's Signature
Item
To be completed by the Principal Investigator: I have assumed responsibility for completeness and accuracy of all data recorded on these Maintenance and Follow-Up Period Case Report Forms. Signature
text
C2346576 (UMLS CUI [1])
Investigator's Name
Item
To be completed by the Principal Investigator: I have assumed responsibility for completeness and accuracy of all data recorded on these Maintenance and Follow-Up Period Case Report Forms. Print Name:
text
C2826892 (UMLS CUI [1])
Date of Report
Item
Date
date
C1302584 (UMLS CUI [1])