ID

43841

Descrição

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 Study Completion

Palavras-chave

D009462

End of Study

Klinische Studie [Dokumenttyp]

Parkinsons Disease

10/10/2017 10/10/2017 -
20/09/2021 20/09/2021 -

Titular dos direitos

GlaxoSmithKline

Transferido a

20 de setembro de 2021

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC-ND 3.0

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Study Completion Ropinirole in Parkinson's Disease GSK 101468/196

model
Detalhes

Study Completion Ropinirole in Parkinson's Disease GSK 101468/196

1 Formulários

StudyEvent: ODM
1. Study Completion Ropinirole in Parkinson's Disease GSK 101468/196

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Patient Information

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])

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)

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)

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])

Physical Examination

Item Group

Physical Examination

C0031809 (UMLS CUI-1)

General Appearance and Skin

Item

1. General Appearance & Skin:

integer

C1148438 (UMLS CUI [1])
C1123023 (UMLS CUI [2])

General Appearance

Code List

1. General Appearance & Skin:

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Not Done (3)

General Appearance and Skin: Abnormality

Item

1. General Appearance & Skin: If abnormal, describe abnormality.

text

C1148438 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1123023 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])

ENT Examination

Item

2. Head, Eyes, Ears, Nose & Throat:

integer

C0278350 (UMLS CUI [1])

ENT Examination

Code List

2. Head, Eyes, Ears, Nose & Throat:

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Not Done (3)

ENT Examination: Abnormality

Item

2. Head, Eyes, Ears, Nose & Throat: If abnormal, describe abnormality.

text

C0278350 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Cardiovascular Examination

Item

3. Cardiovascular:

integer

C3854344 (UMLS CUI [1])

Cardiovascular Examination

Code List

3. Cardiovascular:

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Not Done (3)

Cardiovascular Examination: Abnormality

Item

3. Cardiovascular: If abnormal, describe abnormality.

text

C3854344 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Respiratory Examination

Item

4. Respiratory:

integer

C0436121 (UMLS CUI [1])

Respiratory Examination

Code List

4. Respiratory:

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Not Done (3)

Respiratory Examination: Abnormality

Item

4. Respiratory: If abnormal, describe abnormality.

text

C0436121 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Abdominal Examination

Item

5. Abdominal & Gastrointestinal:

integer

C0438120 (UMLS CUI [1])

Abdominal Examination

Code List

5. Abdominal & Gastrointestinal:

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Not Done (3)

Abdominal Examination: Abnormality

Item

5. Abdominal & Gastrointestinal Examination: If abnormal, describe abnormality.

text

C0438120 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Musculoskeletal Examination

Item

6. Musculoskeletal:

integer

C0026860 (UMLS CUI [1])

Musculoskeletal Examination

Code List

6. Musculoskeletal:

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Not Done (3)

Musculoskeletal Examination: Abnormality

Item

6. Musculoskeletal: If abnormal, describe abnormality.

text

C0026860 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Neurological Examination

Item

7. Neurological:

integer

C0027853 (UMLS CUI [1])

Neurological Examination

Code List

7. Neurological:

CL Item

Abnormal (2)

Neurological Examination: Abnormality

Item

7. Neurological: If abnormal, describe abnormality.

text

C0027853 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Neurological Examination: Abnormality

Code List

7. Neurological: If abnormal, describe abnormality.

CL Item

Parkinson's Disease (Parkinson's Disease)

Genitourinary Examination

Item

8. Genitourinary:

integer

C0555350 (UMLS CUI [1])

Genitourinary Examination

Code List

8. Genitourinary:

CL Item

Normal (1)

CL Item

Abnormal (2)

CL Item

Not Done (3)

Genitourinary Examination: Abnormality

Item

8. Genitourinary: If abnormal, describe abnormality.

text

C0555350 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Other Examination

Item

9. Other

integer

C0260879 (UMLS CUI [1])

Other Examination

Code List

9. Other

CL Item

Abnormal (2)

CL Item

Not Applicable (3)

Other Examination: Abnormality

Item

9. Other: If abnormal, describe abnormality.

text

C0260879 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

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)

12-Lead ECG

Item Group

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

C0430456 (UMLS CUI-1)

ECG

Item

ECG performed?

text

ECG

Code List

ECG performed?

CL Item

Yes (Yes)

CL Item

Not Performed (Not Performed)

Time of ECG

Item

Actual Time of ECG reading (24-hour clock)

time

C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])

Heart Rate

Item

Heart Rate

float

C0018810 (UMLS CUI [1])

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

C0855331 (UMLS CUI [1])

ECG Finding

Item

Overall ECG Results

text

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 Finding: Clinically Significant

Item

Overall ECG Result: If abnormal - clinically significant, describe:

text

C0438154 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])

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Study Completion Ropinirole in Parkinson's Disease GSK 101468/196

Study Completion Ropinirole in Parkinson's Disease GSK 101468/196

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