ID

26226

Beschreibung

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

Stichworte

Versionen (1)
  1. 12.10.17 12.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. Oktober 2017

DOI

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Lizenz

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

Englisch

Follow-Up Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulare  
Patient Information
Beschreibung

Patient Information

Alias
UMLS CUI-1
C1955348
Patient No.
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Orthostatic Blood Pressure/ Pulse
Beschreibung

Orthostatic Blood Pressure/ Pulse

Alias
UMLS CUI-1
C1095971
Time Point (Time [24-hour clock])
Beschreibung

Time of Examination

Datentyp

time

Maßeinheiten
  • 24hr:min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0430022
24hr:min
Semi-Supine Heart Rate
Beschreibung

Semi-Supine Heart Rate

Datentyp

float

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
bpm
Standing Heart Rate
Beschreibung

Erect Heart Rate

Datentyp

float

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
bpm
Semi-Supine Systolic Blood Pressure
Beschreibung

Semi-Supine Systolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-Supine Diastolic Blood Pressure
Beschreibung

Semi-Supine Diastolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
mmHg
Standing Systolic Blood Pressure
Beschreibung

Erect Systolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mmHg
Standing Diastolic Blood Pressure
Beschreibung

Erect Diastolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mmHg
Study Drug Compliance
Beschreibung

Study Drug Compliance

Alias
UMLS CUI-1
C1321605
Total number of tablets dispensed at last visit.
Beschreibung

Split up in groups of 2, 3, 4 or 8 mg.

Datentyp

text

Alias
UMLS CUI [1]
C0805077
Total Number of tablets returned at visit.
Beschreibung

Split up in groups of 2, 3, 4 or 8mg.

Datentyp

text

Alias
UMLS CUI [1]
C2699071
Number of tablets patient should have taken (assuming 100% compliance).
Beschreibung

Compliance

Datentyp

text

Alias
UMLS CUI [1]
C1321605
If there were missed doses, please record. Date
Beschreibung

Missed Dose: Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
If there were missed doses, please record. Tablet(s)
Beschreibung

Missed Dose: Tablet

Datentyp

text

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0039225
If there were missed doses, please record. Dose in mg
Beschreibung

Missed Dose: Dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0178602
mg
If there were missed doses, please record. Reason
Beschreibung

Missed Dose: Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0566251
Pregnancy Test (betaHCG)
Beschreibung

Pregnancy Test (betaHCG)

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Beschreibung

Pregnancy Test

Datentyp

integer

Alias
UMLS CUI [1]
C0032976
If YES, what type of pregnancy was performed?
Beschreibung

Type of Pregnancy Test

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0332307
If YES, Date of Test:
Beschreibung

Date of Pregnancy Test

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
If YES, Result:
Beschreibung

Pregnancy Test Finding

Datentyp

integer

Alias
UMLS CUI [1]
C0427777
Completion of Dosing Period
Beschreibung

Completion of Dosing Period

Alias
UMLS CUI-1
C0805732
UMLS CUI-2
C0178602
Did the patient complete the maintenance period?
Beschreibung

Competion of maintenance period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C0677908
If the answer to the question is NO, check the one most significant reason below. Adverse Event
Beschreibung

Adverse Event

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
If the answer to the question is NO, check the one most significant reason below. Adverse event, specify:
Beschreibung

Adverse Event: Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
If the answer to the question is NO, check the one most significant reason below. Patient Request.
Beschreibung

Patient Request

Datentyp

integer

Alias
UMLS CUI [1]
C0332153
If the answer to the question is NO, check the one most significant reason below. Patient request (unrelated to an AE), specify:
Beschreibung

Patient Request: Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0332153
UMLS CUI [1,2]
C2348235
If the answer to the question is NO, check the one most significant reason below. Non-compliance.
Beschreibung

Compliance

Datentyp

integer

Alias
UMLS CUI [1]
C1321605
If the answer to the question is NO, check the one most significant reason below. Non-compliance (unrelated to an AE), specify:
Beschreibung

Compliance: Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348235
If the answer to the question is NO, check the one most significant reason below. Investigator judgement.
Beschreibung

Judgement

Datentyp

integer

Alias
UMLS CUI [1]
C0022423
If the answer to the question is NO, check the one most significant reason below. Investigator judgement, specify:
Beschreibung

Judgement: Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0022423
UMLS CUI [1,2]
C2348235
If the answer to the question is NO, check the one most significant reason below. Termination of patient dosing by sponsor.
Beschreibung

Termination

Datentyp

integer

Alias
UMLS CUI [1]
C0871548
If the answer to the question is NO, check the one most significant reason below. Protocol Violation.
Beschreibung

Protocol Violation

Datentyp

integer

Alias
UMLS CUI [1]
C1709750
If the answer to the question is NO, check the one most significant reason below. Protocol violation, specify:
Beschreibung

Protocol Violation: Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
If the answer to the question is NO, check the one most significant reason below. Death; complete the Patient Death CRF.
Beschreibung

Death

Datentyp

integer

Alias
UMLS CUI [1]
C0011065
If the answer to the question is NO, check the one most significant reason below. Other.
Beschreibung

Other Reason

Datentyp

integer

Alias
UMLS CUI [1]
C3840932
If the answer to the question is NO, check the one most significant reason below. Other, specify:
Beschreibung

Other Reason: Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
Date of study termination (last protocol assessment):
Beschreibung

End Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
Last dose in maintenance period:
Beschreibung

Last Dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1517741
mg
Date of last dose in maintenance period:
Beschreibung

Date of Last Dose

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1762893
dd-mmm-yyyy
Was the patient down-titrated for 1 week?
Beschreibung

Down Titration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2983683
UMLS CUI [1,2]
C0205216
Was the patient down-titrated for 1 week? If NO, please specify reason:
Beschreibung

Down Titration: Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2983683
UMLS CUI [1,2]
C0205216
UMLS CUI [1,3]
C0566251
Was the patient down-titrated for 1 week? If NO, specify duration of Down Titrationn:
Beschreibung

Down Titration: Duration

Datentyp

text

Alias
UMLS CUI [1,1]
C2983683
UMLS CUI [1,2]
C0205216
UMLS CUI [1,3]
C0449238
Last dose in Down-Titration:
Beschreibung

Down Titration: Last Dosage

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C2983683
UMLS CUI [1,2]
C0205216
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1517741
mg
Date of last Down-Titration Dose:
Beschreibung

Down Titration: Date of Last Dose

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2983683
UMLS CUI [1,2]
C0205216
UMLS CUI [1,3]
C1762893
dd-mmm-yyyy
Investigator Signature
Beschreibung

Investigator Signature

Alias
UMLS CUI-1
C2346576
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
Beschreibung

Investigator's Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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:
Beschreibung

Investigator's Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Date of Report

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1302584
dd-mmm-yyyy
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Ähnliche Modelle

Follow-Up Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Number
Item
Patient No.
text
C1830427 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Orthostatic Blood Pressure/ Pulse
C1095971 (UMLS CUI-1)
Time of Examination
Item
Time Point (Time [24-hour clock])
time
C0040223 (UMLS CUI [1,1])
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])
Erect Heart Rate
Item
Standing Heart Rate
float
C0522014 (UMLS CUI [1,1])
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])
Erect Systolic Blood Pressure
Item
Standing Systolic Blood Pressure
float
C0522014 (UMLS CUI [1,1])
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])
Item Group
Study Drug Compliance
C1321605 (UMLS CUI-1)
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])
Missed Dose: Tablet
Item
If there were missed doses, please record. Tablet(s)
text
C1709043 (UMLS CUI [1,1])
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])
Missed Dose: Reason
Item
If there were missed doses, please record. Reason
text
C1709043 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item Group
Pregnancy Test (betaHCG)
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test performed?
integer
C0032976 (UMLS CUI [1])
Pregnancy Test
Code List
Was a pregnancy test performed?
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])
Type of Pregnancy Test
Code List
If YES, what type of pregnancy was performed?
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])
Item
If YES, Result:
integer
C0427777 (UMLS CUI [1])
Pregnancy Test Finding
Code List
If YES, Result:
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Completion of Dosing Period
C0805732 (UMLS CUI-1)
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])
Item
If the answer to the question is NO, check the one most significant reason below. Adverse Event
integer
C0877248 (UMLS CUI [1])
Adverse Event
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])
Item
If the answer to the question is NO, check the one most significant reason below. Patient Request.
integer
C0332153 (UMLS CUI [1])
Patient Request
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])
Item
If the answer to the question is NO, check the one most significant reason below. Non-compliance.
integer
C1321605 (UMLS CUI [1])
Compliance
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])
Item
If the answer to the question is NO, check the one most significant reason below. Investigator judgement.
integer
C0022423 (UMLS CUI [1])
Judgement
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])
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])
Termination
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])
Protocol Violation
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])
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])
Death
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])
Other Reason
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])
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])
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])
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])
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])
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])
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])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
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])
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