Informazione:
Errore:
ID
26169
Descrizione
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 xx Months After Initial Titration
Keywords
versioni (1)
- 10/10/17 10/10/17 -
Titolare del copyright
GlaxoSmithKline
Caricato su
10 ottobre 2017
DOI
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Licenza
Creative Commons BY-NC-ND 3.0
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After Initial Titration Ropinirole in Parkinson's Disease GSK 101468/196
After Initial Titration Ropinirole in Parkinson's Disease GSK 101468/196
Similar models
After Initial Titration Ropinirole in Parkinson's Disease GSK 101468/196
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Months After Initial Titration
Item
__Months After Initial Titration (i.e. M36, M39, M42, etc.)
text
C2983683 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C0439231 (UMLS CUI [1,2])
Patient Number
Item
Patient No.
text
C1830427 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (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])
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])
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])
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])
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])
C0566251 (UMLS CUI [1,2])
Last Dosage of Ropinirole
Item
Last study drug dose:
float
C0244821 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Date of Last Dose
Item
Date of last study drug dose:
date
C1762893 (UMLS CUI [1])
Time of Last Dose
Item
Time of last study drug dose (24 hour clock):
time
C0946444 (UMLS CUI [1])
Prescribed Dose
Item
Enter the dose of study drug prescribed at this visit:
float
C0678766 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,2])
Up Titration
Item
is the patient being up titrated at this visit?
boolean
C0205217 (UMLS CUI [1,1])
C2983683 (UMLS CUI [1,2])
C2983683 (UMLS CUI [1,2])
Time of Examination
Item
Time Point (Time [24-hour clock])
time
C0040223 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
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])
C0018810 (UMLS CUI [1,2])
Erect Heart Rate
Item
Standing Heart Rate
float
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
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])
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])
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])
C0428883 (UMLS CUI [1,2])
Item Group
Unified Parkinson's Disease Rating Scale (UPDRS)
C3639721 (UMLS CUI-1)
Unified Parkinson's Disease Rating Scale
Item
Unified Parkinson's Disease Rating Scale (UPDRS)
text
C3639721 (UMLS CUI [1])
Item Group
Laboratory Evaluations: Hematology - Complete this page only if this is a 6-months visit. Obtain blood samples at the Month 36 visit or the Study Completion Visit and then every 6 months after that. Note: Please complete the clinically significant (Clin Sig) columni for values out of normal range.
C0474523 (UMLS CUI-1)
Hematology
Item
Hematology. Performed?
boolean
C0474523 (UMLS CUI [1])
Hematology: Collection Date
Item
Date of Sample:
date
C0474523 (UMLS CUI [1,1])
C1317250 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin: Result
float
C0019046 (UMLS CUI [1])
Hemoglobin: Unit
Item
Hemoglobin: Units
text
C0518015 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Hemoglobin: Clinically Significant
Item
Hemoglobin: Clin Sig
boolean
C0518015 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Hematocrit
Item
Hematocrit: Result
float
C0518014 (UMLS CUI [1])
Hematocrit: Unit
Item
Hematocrit: Units
text
C0518014 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Hematocrit: Clinically Significant
Item
Hematocrit: Clin Sig
boolean
C0518014 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Red Blood Count
Item
RBC: Result
float
C1287262 (UMLS CUI [1])
Red Blood Count: Unit
Item
RBC: Units
text
C1287262 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Red Blood Count: Clinically Significant
Item
RBC: Clin Sig
boolean
C1287262 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
White Blood Count
Item
WBC: Result
float
C0023508 (UMLS CUI [1])
White Blood Count: Unit
Item
WBC: Units
text
C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
White Blood Count: Clinically Significant
Item
WBC: Clin Sig
boolean
C0023508 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Platelets
Item
Platelets: Result
float
C0005821 (UMLS CUI [1])
Platelets: Unit
Item
Platelets: Units
text
C0005821 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Platelets: Clinically Significant
Item
Platelets: Clin Sig
boolean
C0005821 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Item Group
Laboratory Evaluations: Serum Chemistry - Complete this page only if this is a 6-months visit. Obtain blood samples at the Month 36 visit or the Study Completion Visit and then every 6 months after that. Note: Please complete the clinically significant (Clin Sig) columni for values out of normal range.
C1883010 (UMLS CUI-1)
Serum Chemistry
Item
Serum Chemistry: Performed?
boolean
C1883010 (UMLS CUI [1])
Serum Chemistry: Collection Date
Item
Date of Sample:
date
C1883010 (UMLS CUI [1,1])
C1317250 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,2])
Sodium
Item
Sodium: Result
float
C0337443 (UMLS CUI [1])
Sodium: Unit
Item
Sodium: Units
text
C0337443 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Sodium: Clinically Significant
Item
Sodium: Clin Sig
boolean
C0337443 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Potassium
Item
Potassium: Result
float
C0202194 (UMLS CUI [1])
Potassium: Unit
Item
Potassium: Units
text
C0202194 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Potassium: Clinically Significant
Item
Potassium: Clin Sig
boolean
C0202194 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Urea
Item
Urea: Results
float
C0523961 (UMLS CUI [1])
Urea: Unit
Item
Urea: Units
text
C0523961 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Urea: Clinically Significant
Item
Urea: Clin Sig
boolean
C0523961 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Creatinine
Item
Creatinine: Results
float
C0201976 (UMLS CUI [1])
Creatinine: Unit
Item
Creatinine: Units
text
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Creatinine: Clinically Significant
Item
Creatinine: Clin Sig
boolean
C0201976 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Total Protein
Item
Protein, total: Result
float
C0555903 (UMLS CUI [1])
Total Protein: Unit
Item
Protein, total: Units
text
C0555903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Total Protein: Clinically Significant
Item
Protein, total: Clin Sig
boolean
C0555903 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Albumin
Item
Albumin: Result
float
C0201838 (UMLS CUI [1])
Albumin: Unit
Item
Albumin: Units
text
C0201838 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Albumin: Clinically Significant
Item
Albumin: Clin Sig
boolean
C0201838 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Globulin
Item
Globulin: Results
float
C0877347 (UMLS CUI [1])
Globulin: Unit
Item
Globulin: Units
text
C0877347 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Globulin: Clinically Significant
Item
Globulin: Clin Sig
boolean
C0877347 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Total Bilirubin
Item
Bilirubin, total: Result
float
C0201913 (UMLS CUI [1])
Total Bilirubin: Unit
Item
Bilirubin, total: Units
text
C0201913 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Total Bilirubin: Clinically Significant
Item
Bilirubin, total: Clin Sig
boolean
C0201913 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
AST
Item
AST (SGOT): Result
float
C0201899 (UMLS CUI [1])
AST: Unit
Item
AST (SGOT): Units
text
C0201899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
AST: Clinically Significant
Item
AST (SGOT): Clin Sig
boolean
C0201899 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT): Result
float
C0201836 (UMLS CUI [1])
ALT: Unit
Item
ALT (SGPT): Units
text
C0201836 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
ALT: Clinically Significant
Item
ALT (SGPT): Clin Sig
boolean
C0201836 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase: Result
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase: Unit
Item
Alkaline Phosphatase: Units
text
C0201850 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Alkaline Phosphatase: Clinically Significant
Item
Alkaline Phosphatase: Clin Sig
boolean
C0201850 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Calcium
Item
Calcium: Result
float
C0201925 (UMLS CUI [1])
Calcium: Unit
Item
Calcium: Units
text
C0201925 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Calcium: Clinically Significant
Item
Calcium: Clin Sig
boolean
C0201925 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Phosphate
Item
Phosphate: Result
float
C0523826 (UMLS CUI [1])
Phosphate: Unit
Item
Phosphate: Units
text
C0523826 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Phosphate: Clinically Significant
Item
Phosphate: Clin Sig
boolean
C0523826 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,2])
Non-Fasting Glucose
Item
Glucose (non-fasting): Results
float
C2347359 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C0337438 (UMLS CUI [1,2])
Non-Fasting Glucose: Unit
Item
Glucose (non-fasting): Units
text
C2347359 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0337438 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Non-Fasting Glucose: Clinically Significant
Item
Glucose (non-fasting): Clin Sig
boolean
C2347359 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,3])
C0337438 (UMLS CUI [1,2])
C2826633 (UMLS CUI [1,3])
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])
C0332307 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)