ID

26502

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 Unscheduled Visit

Trefwoorden

Versies (1)
  1. 18-10-17 18-10-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

18 oktober 2017

DOI

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Licentie

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

Engels

Unscheduled Visit Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulieren  
Patient Information
Beschrijving

Patient Information

Alias
UMLS CUI-1
C1955348
Patient No.
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Date of Visit
Beschrijving

Date of Visit

Datatype

date

Maateenheden
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Unscheduled Visit
Beschrijving

Unscheduled Visit

Alias
UMLS CUI-1
C0545082
UMLS CUI-2
C3854240
Will the patient continue on study?
Beschrijving

If NO, please complete Study Completion CRFs.

Datatype

boolean

Alias
UMLS CUI [1]
C0805733
Has the patient experienced an Adverse Event?
Beschrijving

If YES, please record on Adverse Event CRFs.

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Will the patient continue on the dose of study medication prescribed at the last study visit?
Beschrijving

Study Drug Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
Will the patient continue on the dose of study medication prescribed at the last study visit? If NO, please indicate dose of study medication prescribed at this visit:
Beschrijving

Study Drug Dosage Specification

Datatype

float

Maateenheden
  • mg/d
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2348235
mg/d
Is the patient being up titrated at this visit?
Beschrijving

If YES, please document pre and post dose Blood Pressure/Pulse management.

Datatype

boolean

Alias
UMLS CUI [1]
C2983683
Orthostatic Blood Pressure/ Pulse
Beschrijving

Orthostatic Blood Pressure/ Pulse

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

Repeat on A1 Predose A2 Predose 1h Post-Dose 2h Post-Dose

Datatype

time

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

Semi-Supine Heart Rate

Datatype

float

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
bpm
Standing Heart Rate
Beschrijving

Erect Heart Rate

Datatype

float

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

Semi-Supine Systolic Blood Pressure

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-Supine Diastolic Blood Pressure
Beschrijving

Semi-Supine Diastolic Blood Pressure

Datatype

float

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

Erect Systolic Blood Pressure

Datatype

float

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

Erect Diastolic Blood Pressure

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mmHg
Study Drug Compliance
Beschrijving

Study Drug Compliance

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

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

Datatype

text

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

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

Datatype

text

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

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

Datatype

text

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

Missed Dose: Date

Datatype

date

Maateenheden
  • 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)
Beschrijving

Missed Dose: Tablet

Datatype

text

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

Missed Dose: Dosage

Datatype

float

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

Missed Dose: Reason

Datatype

text

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0566251
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Similar models

Unscheduled Visit Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Unscheduled Visit
C0545082 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Continuation Status
Item
Will the patient continue on study?
boolean
C0805733 (UMLS CUI [1])
Adverse Event
Item
Has the patient experienced an Adverse Event?
boolean
C0877248 (UMLS CUI [1])
Study Drug Dosage
Item
Will the patient continue on the dose of study medication prescribed at the last study visit?
boolean
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Study Drug Dosage Specification
Item
Will the patient continue on the dose of study medication prescribed at the last study visit? If NO, please indicate dose of study medication prescribed at this visit:
float
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Titration
Item
Is the patient being up titrated at this visit?
boolean
C2983683 (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])
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