ID

26144

Description

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 1

Keywords

Versions (1)
  1. 10/9/17 10/9/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY-NC-ND 3.0
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Titration Week 1 Ropinirole in Parkinson's Disease GSK 101468/196

English

Titration Week 1 Ropinirole in Parkinson's Disease GSK 101468/196

1 forms  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient No.
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Date of Visit
Description

Date of Visit

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Clinical Global Impression
Description

Clinical Global Impression

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

Severity of Illness

Data type

integer

Alias
UMLS CUI [1]
C0521117
Study Drug Dosing
Description

Study Drug Dosing

Alias
UMLS CUI-1
C0178602
Did subject take Ropinirole IR after Study completion visit?
Description

Ropinirole

Data type

boolean

Alias
UMLS CUI [1]
C0244821
If YES, enter the dose of Ropinirole CR that the subject is being switchend to (per protocol dosing guidelines) and recrod the Ropinirole IR medication taken on the CRF Medications Taken After Study 196 Completion Visit CRF Page.
Description

Dosage of Ropinirole

Data type

float

Measurement units
  • mg/d
Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0178602
mg/d
If NO (patient is not on Ropinirole IR), patient must begin up-titration, please enter the dose of study drug prescribed at this and record PD medications taken on the CRF MEdications Taken After Study 196 Completion Visit CRF Page.
Description

Restart of Ropinirole

Data type

float

Measurement units
  • mg/d
Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0580673
mg/d
Time of first dose (24 hour clock)
Description

Time of first dose

Data type

time

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

Orthostatic Blood Pressure/ Pulse

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

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

Data type

time

Measurement units
  • 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)
Description

Unscheduled Time of Examination

Data type

time

Measurement units
  • 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
Description

Unscheduled Date of Examination

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826643
UMLS CUI [1,2]
C3854240
dd-mmm-yyyy
Semi-Supine Heart Rate
Description

Semi-Supine Heart Rate

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
bpm
Standing Heart Rate
Description

Erect Heart Rate

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
bpm
Semi-Supine Systolic Blood Pressure
Description

Semi-Supine Systolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-Supine Diastolic Blood Pressure
Description

Semi-Supine Diastolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
mmHg
Standing Systolic Blood Pressure
Description

Erect Systolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mmHg
Standing Diastolic Blood Pressure
Description

Erect Diastolic Blood Pressure

Data type

float

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

Titration Week 1 Ropinirole in Parkinson's Disease GSK 101468/196

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Item Group
Study Drug Dosing
C0178602 (UMLS CUI-1)
Ropinirole
Item
Did subject take Ropinirole IR after Study completion visit?
boolean
C0244821 (UMLS CUI [1])
Dosage of Ropinirole
Item
If YES, enter the dose of Ropinirole CR that the subject is being switchend to (per protocol dosing guidelines) and recrod the Ropinirole IR medication taken on the CRF Medications Taken After Study 196 Completion Visit CRF Page.
float
C0244821 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Restart of Ropinirole
Item
If NO (patient is not on Ropinirole IR), patient must begin up-titration, please enter the dose of study drug prescribed at this and record PD medications taken on the CRF MEdications Taken After Study 196 Completion Visit CRF Page.
float
C0244821 (UMLS CUI [1,1])
C0580673 (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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