ID

26069

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 Screening

Keywords

Versions (1)
  1. 10/5/17 10/5/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 5, 2017

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License

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

English

Screening 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 Workshteet. 1. Severity of illness (0-7)
Description

Severity of Illness

Data type

integer

Alias
UMLS CUI [1]
C0521117
Screening 12-Lead Electrocardiogram Report (Originial ECGs must be kept in the patient medical charts.)
Description

Screening 12-Lead Electrocardiogram Report (Originial ECGs must be kept in the patient medical charts.)

Alias
UMLS CUI-1
C0430456
If the patient is re-enrolling into the Study extension within 4 weeks of completing Study 196, and these assessments were obtained at the end of three years of participation in Study 196, they need not be repeated. ECG performed?
Description

ECG

Data type

boolean

Alias
UMLS CUI [1]
C1623258
Actual Time of ECG Reading
Description

After 5 minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II, III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart raete (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arryhtmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
24hr:min
Heart Rate
Description

After 5 minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II, III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart raete (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arryhtmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Data type

float

Measurement units
  • bpm
bpm
P-R Interval
Description

After 5 minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II, III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart raete (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arryhtmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS Interval
Description

After 5 minutes in the semi-supine position, a 12-lead ECG (using an ECG machine of adequate standard) will be performed. Six limb leads, as specified in Einthoven (I, II, III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart raete (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arryhtmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0520880
sec
QTc Interval
Description

QTc Interval

Data type

float

Measurement units
  • sec
sec
Overall ECG Results:
Description

ECG Finding

Data type

integer

Alias
UMLS CUI [1]
C0438154
If abnormal - clinically significant, describe:
Description

ECG Abnormal

Data type

text

Alias
UMLS CUI [1]
C0522055
Unified Parkinson's Disease Rating Scale (UPDRS)
Description

Unified Parkinson's Disease Rating Scale (UPDRS)

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0681889
Unified Parkinson's Disease Rating Scale (UPDRS)
Description

Unified Parkinson's Disease Rating Scale (UPDRS)

Data type

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0681889
Epworth Sleep Scale (ESS)
Description

Epworth Sleep Scale (ESS)

Alias
UMLS CUI-1
C3541276
Epworth Sleep Scale (ESS)
Description

Epworth Sleep Scale

Data type

text

Alias
UMLS CUI [1]
C3541276
Orthostatic Blood Pressure/ Pulse
Description

Orthostatic Blood Pressure/ Pulse

Alias
UMLS CUI-1
C1095971
Time Point: Date
Description

Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0011008
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 [1,1]
C0522019
UMLS CUI [1,2]
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
Medication taken after Study 196 Completion Visit (Record all medications taken by the patient after the Study 196 Completion Visit/Follow-up, including those taken for Parkinson's Disease. Please enter only medications taken between Study Completion/Follow-up and the Re-Enrollment Screening Visit as well as any doses of Ropinirole IR taken during this period. Only applies to subjects who have re-enrolled in the study after completion at 36 months.
Description

Medication taken after Study 196 Completion Visit (Record all medications taken by the patient after the Study 196 Completion Visit/Follow-up, including those taken for Parkinson's Disease. Please enter only medications taken between Study Completion/Follow-up and the Re-Enrollment Screening Visit as well as any doses of Ropinirole IR taken during this period. Only applies to subjects who have re-enrolled in the study after completion at 36 months.

Alias
UMLS CUI-1
C0013227
Medication - None?
Description

Medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Use Generic Name
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Date Started
Description

Start Date

Data type

date

Measurement units
  • dd-mmm-yyyy
dd-mmm-yyyy
Date Stopped
Description

End Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
Dose (e.g. 10 mg)
Description

Dose

Data type

text

Alias
UMLS CUI [1]
C3174092
Frequency (e.g. tid)
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Route If Other, Specify:
Description

Administration Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2348235
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Similar models

Screening 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 Workshteet. 1. Severity of illness (0-7)
integer
C0521117 (UMLS CUI [1])
Item Group
Screening 12-Lead Electrocardiogram Report (Originial ECGs must be kept in the patient medical charts.)
C0430456 (UMLS CUI-1)
ECG
Item
If the patient is re-enrolling into the Study extension within 4 weeks of completing Study 196, and these assessments were obtained at the end of three years of participation in Study 196, they need not be repeated. ECG performed?
boolean
C1623258 (UMLS CUI [1])
Time of ECG
Item
Actual Time of ECG Reading
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
float
PR Interval
Item
P-R Interval
float
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
float
C0520880 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
float
Item
Overall ECG Results:
integer
C0438154 (UMLS CUI [1])
ECG Finding
Code List
Overall ECG Results:
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
ECG Abnormal
Item
If abnormal - clinically significant, describe:
text
C0522055 (UMLS CUI [1])
Item Group
Unified Parkinson's Disease Rating Scale (UPDRS)
C0030567 (UMLS CUI-1)
C0681889 (UMLS CUI-2)
Unified Parkinson's Disease Rating Scale (UPDRS)
Item
Unified Parkinson's Disease Rating Scale (UPDRS)
text
C0030567 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
Item Group
Epworth Sleep Scale (ESS)
C3541276 (UMLS CUI-1)
Epworth Sleep Scale
Item
Epworth Sleep Scale (ESS)
text
C3541276 (UMLS CUI [1])
Item Group
Orthostatic Blood Pressure/ Pulse
C1095971 (UMLS CUI-1)
Date
Item
Time Point: Date
date
C0011008 (UMLS CUI [1])
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
C0522019 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
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
Medication taken after Study 196 Completion Visit (Record all medications taken by the patient after the Study 196 Completion Visit/Follow-up, including those taken for Parkinson's Disease. Please enter only medications taken between Study Completion/Follow-up and the Re-Enrollment Screening Visit as well as any doses of Ropinirole IR taken during this period. Only applies to subjects who have re-enrolled in the study after completion at 36 months.
C0013227 (UMLS CUI-1)
Medication
Item
Medication - None?
boolean
C0013227 (UMLS CUI [1])
Drug Name
Item
Use Generic Name
text
C2360065 (UMLS CUI [1])
Start Date
Item
Date Started
date
End Date
Item
Date Stopped
date
C0806020 (UMLS CUI [1])
Dose
Item
Dose (e.g. 10 mg)
text
C3174092 (UMLS CUI [1])
Frequency
Item
Frequency (e.g. tid)
text
C3476109 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
Administration Route
Code List
Route
CL Item
IV (IV)
CL Item
IM (IM)
CL Item
PO (PO)
CL Item
SC (SC)
CL Item
PR (PR)
CL Item
Sublingual (Sublingual)
CL Item
Inhaled (Inhaled)
CL Item
Topical (Topical)
CL Item
Other (Other)
Administration Route
Item
Route If Other, Specify:
text
C0013153 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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