ID

26169

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 xx Months After Initial Titration

Trefwoorden

10-10-17 10-10-17 -

Houder van rechten

GlaxoSmithKline

Geüploaded op

10 oktober 2017

DOI

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Licentie

Creative Commons BY-NC-ND 3.0

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After Initial Titration Ropinirole in Parkinson's Disease GSK 101468/196

model
Details

After Initial Titration Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulieren

StudyEvent: ODM
1. After Initial Titration Ropinirole in Parkinson's Disease GSK 101468/196

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Patient Information

Item Group

Patient Information

C1955348 (UMLS CUI-1)

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])

Patient Number

Item

Patient No.

text

C1830427 (UMLS CUI [1])

Date of Visit

Item

Date of Visit

date

C1320303 (UMLS CUI [1])

Clinical Global Impression

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])

Compliance

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])

Dosage

Item Group

Study Drug Dosing

C0178602 (UMLS CUI-1)

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])

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])

Orthostatic Blood Pressure

Item Group

Orthostatic Blood Pressure/ Pulse

C1095971 (UMLS CUI-1)

Up Titration

Item

is the patient being up titrated at this visit?

boolean

C0205217 (UMLS CUI [1,1])
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])

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])

Unified Parkinson's Disease Rating Scale (UPDRS)

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])

Hematology

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])

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])

Hemoglobin: Clinically Significant

Item

Hemoglobin: Clin Sig

boolean

C0518015 (UMLS CUI [1,1])
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])

Hematocrit: Clinically Significant

Item

Hematocrit: Clin Sig

boolean

C0518014 (UMLS CUI [1,1])
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])

Red Blood Count: Clinically Significant

Item

RBC: Clin Sig

boolean

C1287262 (UMLS CUI [1,1])
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])

White Blood Count: Clinically Significant

Item

WBC: Clin Sig

boolean

C0023508 (UMLS CUI [1,1])
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])

Platelets: Clinically Significant

Item

Platelets: Clin Sig

boolean

C0005821 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])

Serum Chemistry

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])

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])

Sodium: Clinically Significant

Item

Sodium: Clin Sig

boolean

C0337443 (UMLS CUI [1,1])
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])

Potassium: Clinically Significant

Item

Potassium: Clin Sig

boolean

C0202194 (UMLS CUI [1,1])
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])

Urea: Clinically Significant

Item

Urea: Clin Sig

boolean

C0523961 (UMLS CUI [1,1])
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])

Creatinine: Clinically Significant

Item

Creatinine: Clin Sig

boolean

C0201976 (UMLS CUI [1,1])
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])

Total Protein: Clinically Significant

Item

Protein, total: Clin Sig

boolean

C0555903 (UMLS CUI [1,1])
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])

Albumin: Clinically Significant

Item

Albumin: Clin Sig

boolean

C0201838 (UMLS CUI [1,1])
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])

Globulin: Clinically Significant

Item

Globulin: Clin Sig

boolean

C0877347 (UMLS CUI [1,1])
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])

Total Bilirubin: Clinically Significant

Item

Bilirubin, total: Clin Sig

boolean

C0201913 (UMLS CUI [1,1])
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])

AST: Clinically Significant

Item

AST (SGOT): Clin Sig

boolean

C0201899 (UMLS CUI [1,1])
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])

ALT: Clinically Significant

Item

ALT (SGPT): Clin Sig

boolean

C0201836 (UMLS CUI [1,1])
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])

Alkaline Phosphatase: Clinically Significant

Item

Alkaline Phosphatase: Clin Sig

boolean

C0201850 (UMLS CUI [1,1])
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])

Calcium: Clinically Significant

Item

Calcium: Clin Sig

boolean

C0201925 (UMLS CUI [1,1])
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])

Phosphate: Clinically Significant

Item

Phosphate: Clin Sig

boolean

C0523826 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])

Non-Fasting Glucose

Item

Glucose (non-fasting): Results

float

C2347359 (UMLS CUI [1,1])
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])

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])

Pregnancy Test

Item Group

Pregnancy Test (betaHCG)

C0032976 (UMLS CUI-1)

Pregnancy Test

Item

Was a pregnancy test performed?

integer

C0032976 (UMLS CUI [1])

Pregnancy Test

Code List

Was a pregnancy test performed?

CL Item

Yes (1)

CL Item

No (2)

CL Item

NA (male or female not of childbearing potential) (3)

Type of Pregnancy Test

Item

If YES, what type of pregnancy was performed?

integer

C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])

Type of Pregnancy Test

Code List

If YES, what type of pregnancy was performed?

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])

Pregnancy Test Finding

Item

If YES, Result:

integer

C0427777 (UMLS CUI [1])

Pregnancy Test Finding

Code List

If YES, Result:

CL Item

Negative (1)

CL Item

Positive (2)

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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

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