ID

26153

Beskrivning

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 Titration Week 5

Nyckelord

Versioner (1)
  1. 2017-10-10 2017-10-10 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 oktober 2017

DOI

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Licens

Creative Commons BY-NC-ND 3.0
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Titration Week 5 Ropinirole in Parkinson's Disease GSK 101468/196

Engelsk

Titration Week 5 Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulär  
Patient Information
Beskrivning

Patient Information

Alias
UMLS CUI-1
C1955348
Patient No.
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C1830427
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Måttenheter
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Clinical Global Impression
Beskrivning

Clinical Global Impression

Alias
UMLS CUI-1
C3639708
Enter the results from the CGI Worksheet. 1. Severity of illness (0 - 7)
Beskrivning

Severity of Illness

Datatyp

integer

Alias
UMLS CUI [1]
C0521117
Enter the results for each category from the CGI Worksheet. 2. Global improvement (0-7)
Beskrivning

Global Improvement

Datatyp

integer

Alias
UMLS CUI [1]
C3639888
Study Drug Compliance
Beskrivning

Study Drug Compliance

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

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

Datatyp

text

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

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

Datatyp

text

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

Compliance

Datatyp

text

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

Missed Dose: Date

Datatyp

date

Måttenheter
  • 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)
Beskrivning

Missed Dose: Tablet

Datatyp

text

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

Missed Dose: Dosage

Datatyp

float

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

Missed Dose: Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0566251
Study Drug Dosing
Beskrivning

Study Drug Dosing

Alias
UMLS CUI-1
C0178602
Enter the dose of study drug prescribed at this visit.
Beskrivning

Dosage of Ropinirole

Datatyp

float

Måttenheter
  • mg/d
Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0178602
mg/d
Time of first dose (24 hour clock)
Beskrivning

Time of first dose

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0040223
24hr:min
Orthostatic Blood Pressure/ Pulse
Beskrivning

Orthostatic Blood Pressure/ Pulse

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

Repeat on Week 5, Day 1 - A1 Predose Week 5, Day 1 - A2 Predose Week 5, Day 1, 1h Post-Dose Week 5, Day 1, 2h Post-Dose

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0430022
24hr:min
If Orthostatic Blood Pressure/Pulse is unscheduled, specify Time Point (24-hour clock)
Beskrivning

Unscheduled Time of Examination

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C3854240
24hr:min
If Orthostatic Blood Pressure/Pulse is unscheduled, specify Date
Beskrivning

Unscheduled Date of Examination

Datatyp

date

Måttenheter
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826643
UMLS CUI [1,2]
C3854240
dd-mmm-yyyy
Semi-Supine Heart Rate
Beskrivning

Semi-Supine Heart Rate

Datatyp

float

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
bpm
Standing Heart Rate
Beskrivning

Erect Heart Rate

Datatyp

float

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

Semi-Supine Systolic Blood Pressure

Datatyp

float

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-Supine Diastolic Blood Pressure
Beskrivning

Semi-Supine Diastolic Blood Pressure

Datatyp

float

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

Erect Systolic Blood Pressure

Datatyp

float

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

Erect Diastolic Blood Pressure

Datatyp

float

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mmHg
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Similar models

Titration Week 5 Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Clinical Global Impression
C3639708 (UMLS CUI-1)
Severity of Illness
Item
Enter the results from the CGI Worksheet. 1. Severity of illness (0 - 7)
integer
C0521117 (UMLS CUI [1])
Global Improvement
Item
Enter the results for each category from the CGI Worksheet. 2. Global improvement (0-7)
integer
C3639888 (UMLS CUI [1])
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
Study Drug Dosing
C0178602 (UMLS CUI-1)
Dosage of Ropinirole
Item
Enter the dose of study drug prescribed at this visit.
float
C0244821 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Time of first dose
Item
Time of first dose (24 hour clock)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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])
Unscheduled Time of Examination
Item
If Orthostatic Blood Pressure/Pulse is unscheduled, specify Time Point (24-hour clock)
time
C0040223 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
Unscheduled Date of Examination
Item
If Orthostatic Blood Pressure/Pulse is unscheduled, specify Date
date
C2826643 (UMLS CUI [1,1])
C3854240 (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])
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