ID

43841

Beschreibung

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

Stichworte

Versionen (2)
  1. 10.10.17 10.10.17 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Patient Information
Beschreibung

Patient Information

Alias
UMLS CUI-1
C1955348
Patient No.
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Clinical Global Impression
Beschreibung

Clinical Global Impression

Alias
UMLS CUI-1
C3639708
Enter the results from the CGI Worksheet. 1. Severity of illness (0 - 7)
Beschreibung

Severity of Illness

Datentyp

integer

Alias
UMLS CUI [1]
C0521117
Enter the results for each category from the CGI Worksheet. 2. Global improvement (0-7)
Beschreibung

Global Improvement

Datentyp

integer

Alias
UMLS CUI [1]
C3639888
Study Drug Compliance
Beschreibung

Study Drug Compliance

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

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

Datentyp

text

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

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

Datentyp

text

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

Compliance

Datentyp

text

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

Missed Dose: Date

Datentyp

date

Maßeinheiten
  • 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)
Beschreibung

Missed Dose: Tablet

Datentyp

text

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

Missed Dose: Dosage

Datentyp

float

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

Missed Dose: Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0566251
Study Drug Dosing
Beschreibung

Study Drug Dosing

Alias
UMLS CUI-1
C0178602
Enter the dose of study drug prescribed at this visit:
Beschreibung

Prescribed Dose

Datentyp

float

Maßeinheiten
  • mg/d
Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0278329
mg/d
Orthostatic Blood Pressure/ Pulse
Beschreibung

Orthostatic Blood Pressure/ Pulse

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

Time of Examination

Datentyp

time

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

Semi-Supine Heart Rate

Datentyp

float

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
bpm
Standing Heart Rate
Beschreibung

Erect Heart Rate

Datentyp

float

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

Semi-Supine Systolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-Supine Diastolic Blood Pressure
Beschreibung

Semi-Supine Diastolic Blood Pressure

Datentyp

float

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

Erect Systolic Blood Pressure

Datentyp

float

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

Erect Diastolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mmHg
Unified Parkinson's Disease Rating Scale (UPDRS)
Beschreibung

Unified Parkinson's Disease Rating Scale (UPDRS)

Alias
UMLS CUI-1
C3639721
Unified Parkinson's Disease Rating Scale (UPDRS)
Beschreibung

Unified Parkinson's Disease Rating Scale

Datentyp

text

Alias
UMLS CUI [1]
C3639721
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
1. General Appearance & Skin:
Beschreibung

General Appearance and Skin

Datentyp

integer

Alias
UMLS CUI [1]
C1148438
UMLS CUI [2]
C1123023
1. General Appearance & Skin: If abnormal, describe abnormality.
Beschreibung

General Appearance and Skin: Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C1704258
2. Head, Eyes, Ears, Nose & Throat:
Beschreibung

ENT Examination

Datentyp

integer

Alias
UMLS CUI [1]
C0278350
2. Head, Eyes, Ears, Nose & Throat: If abnormal, describe abnormality.
Beschreibung

ENT Examination: Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0278350
UMLS CUI [1,2]
C1704258
3. Cardiovascular:
Beschreibung

Cardiovascular Examination

Datentyp

integer

Alias
UMLS CUI [1]
C3854344
3. Cardiovascular: If abnormal, describe abnormality.
Beschreibung

Cardiovascular Examination: Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C3854344
UMLS CUI [1,2]
C1704258
4. Respiratory:
Beschreibung

Respiratory Examination

Datentyp

integer

Alias
UMLS CUI [1]
C0436121
4. Respiratory: If abnormal, describe abnormality.
Beschreibung

Respiratory Examination: Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0436121
UMLS CUI [1,2]
C1704258
5. Abdominal & Gastrointestinal:
Beschreibung

Abdominal Examination

Datentyp

integer

Alias
UMLS CUI [1]
C0438120
5. Abdominal & Gastrointestinal Examination: If abnormal, describe abnormality.
Beschreibung

Abdominal Examination: Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0438120
UMLS CUI [1,2]
C1704258
6. Musculoskeletal:
Beschreibung

Musculoskeletal Examination

Datentyp

integer

Alias
UMLS CUI [1]
C0026860
6. Musculoskeletal: If abnormal, describe abnormality.
Beschreibung

Musculoskeletal Examination: Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0026860
UMLS CUI [1,2]
C1704258
7. Neurological:
Beschreibung

Neurological Examination

Datentyp

integer

Alias
UMLS CUI [1]
C0027853
7. Neurological: If abnormal, describe abnormality.
Beschreibung

Neurological Examination: Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C1704258
8. Genitourinary:
Beschreibung

Genitourinary Examination

Datentyp

integer

Alias
UMLS CUI [1]
C0555350
8. Genitourinary: If abnormal, describe abnormality.
Beschreibung

Genitourinary Examination: Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0555350
UMLS CUI [1,2]
C1704258
9. Other
Beschreibung

Other Examination

Datentyp

integer

Alias
UMLS CUI [1]
C0260879
9. Other: If abnormal, describe abnormality.
Beschreibung

Other Examination: Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0260879
UMLS CUI [1,2]
C1704258
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.
Beschreibung

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.

Alias
UMLS CUI-1
C0474523
Hematology. Performed?
Beschreibung

Hematology

Datentyp

boolean

Alias
UMLS CUI [1]
C0474523
Date of Sample:
Beschreibung

Hematology: Collection Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1317250
dd-mmm-yyyy
Hemoglobin: Result
Beschreibung

Hemoglobin

Datentyp

float

Alias
UMLS CUI [1]
C0019046
Hemoglobin: Units
Beschreibung

Hemoglobin: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C1519795
Hemoglobin: Clin Sig
Beschreibung

Hemoglobin: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C2826633
Hematocrit: Result
Beschreibung

Hematocrit

Datentyp

float

Alias
UMLS CUI [1]
C0518014
Hematocrit: Units
Beschreibung

Hematocrit: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C1519795
Hematocrit: Clin Sig
Beschreibung

Hematocrit: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C2826633
RBC: Result
Beschreibung

Red Blood Count

Datentyp

float

Alias
UMLS CUI [1]
C1287262
RBC: Units
Beschreibung

Red Blood Count: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C1287262
UMLS CUI [1,2]
C1519795
RBC: Clin Sig
Beschreibung

Red Blood Count: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1287262
UMLS CUI [1,2]
C2826633
WBC: Result
Beschreibung

White Blood Count

Datentyp

float

Alias
UMLS CUI [1]
C0023508
WBC: Units
Beschreibung

White Blood Count: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1519795
WBC: Clin Sig
Beschreibung

White Blood Count: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C2826633
Platelets: Result
Beschreibung

Platelets

Datentyp

float

Alias
UMLS CUI [1]
C0005821
Platelets: Units
Beschreibung

Platelets: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C1519795
Platelets: Clin Sig
Beschreibung

Platelets: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C2826633
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.
Beschreibung

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.

Alias
UMLS CUI-1
C1883010
Serum Chemistry: Performed?
Beschreibung

Serum Chemistry

Datentyp

boolean

Alias
UMLS CUI [1]
C1883010
Date of Sample:
Beschreibung

Serum Chemistry: Collection Date

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1883010
UMLS CUI [1,2]
C1317250
dd-mmm-yyyy
Sodium: Result
Beschreibung

Sodium

Datentyp

float

Alias
UMLS CUI [1]
C0337443
Sodium: Units
Beschreibung

Sodium: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C1519795
Sodium: Clin Sig
Beschreibung

Sodium: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C2826633
Potassium: Result
Beschreibung

Potassium

Datentyp

float

Alias
UMLS CUI [1]
C0202194
Potassium: Units
Beschreibung

Potassium: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C1519795
Potassium: Clin Sig
Beschreibung

Potassium: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C2826633
Urea: Results
Beschreibung

Urea

Datentyp

float

Alias
UMLS CUI [1]
C0523961
Urea: Units
Beschreibung

Urea: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0523961
UMLS CUI [1,2]
C1519795
Urea: Clin Sig
Beschreibung

Urea: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0523961
UMLS CUI [1,2]
C2826633
Creatinine: Results
Beschreibung

Creatinine

Datentyp

float

Alias
UMLS CUI [1]
C0201976
Creatinine: Units
Beschreibung

Creatinine: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519795
Creatinine: Clin Sig
Beschreibung

Creatinine: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C2826633
Protein, total: Result
Beschreibung

Total Protein

Datentyp

float

Alias
UMLS CUI [1]
C0555903
Protein, total: Units
Beschreibung

Total Protein: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C1519795
Protein, total: Clin Sig
Beschreibung

Total Protein: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C2826633
Albumin: Result
Beschreibung

Albumin

Datentyp

float

Alias
UMLS CUI [1]
C0201838
Albumin: Units
Beschreibung

Albumin: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C1519795
Albumin: Clin Sig
Beschreibung

Albumin: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C2826633
Globulin: Results
Beschreibung

Globulin

Datentyp

float

Alias
UMLS CUI [1]
C0877347
Globulin: Units
Beschreibung

Globulin: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0877347
UMLS CUI [1,2]
C1519795
Globulin: Clin Sig
Beschreibung

Globulin: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877347
UMLS CUI [1,2]
C2826633
Bilirubin, total: Result
Beschreibung

Total Bilirubin

Datentyp

float

Alias
UMLS CUI [1]
C0201913
Bilirubin, total: Units
Beschreibung

Total Bilirubin: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519795
Bilirubin, total: Clin Sig
Beschreibung

Total Bilirubin: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C2826633
AST (SGOT): Result
Beschreibung

AST

Datentyp

float

Alias
UMLS CUI [1]
C0201899
AST (SGOT): Units
Beschreibung

AST: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519795
AST (SGOT): Clin Sig
Beschreibung

AST: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C2826633
ALT (SGPT): Result
Beschreibung

ALT

Datentyp

float

Alias
UMLS CUI [1]
C0201836
ALT (SGPT): Units
Beschreibung

ALT: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519795
ALT (SGPT): Clin Sig
Beschreibung

ALT: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C2826633
Alkaline Phosphatase: Result
Beschreibung

Alkaline Phosphatase

Datentyp

float

Alias
UMLS CUI [1]
C0201850
Alkaline Phosphatase: Units
Beschreibung

Alkaline Phosphatase: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C1519795
Alkaline Phosphatase: Clin Sig
Beschreibung

Alkaline Phosphatase: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C2826633
Calcium: Result
Beschreibung

Calcium

Datentyp

float

Alias
UMLS CUI [1]
C0201925
Calcium: Units
Beschreibung

Calcium: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0201925
UMLS CUI [1,2]
C1519795
Calcium: Clin Sig
Beschreibung

Calcium: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201925
UMLS CUI [1,2]
C2826633
Phosphate: Result
Beschreibung

Phosphate

Datentyp

float

Alias
UMLS CUI [1]
C0523826
Phosphate: Units
Beschreibung

Phosphate: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0523826
UMLS CUI [1,2]
C1519795
Phosphate: Clin Sig
Beschreibung

Phosphate: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0523826
UMLS CUI [1,2]
C2826633
Glucose (non-fasting): Results
Beschreibung

Non-Fasting Glucose

Datentyp

float

Alias
UMLS CUI [1,1]
C2347359
UMLS CUI [1,2]
C0337438
Glucose (non-fasting): Units
Beschreibung

Non-Fasting Glucose: Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C2347359
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C1519795
Glucose (non-fasting): Clin Sig
Beschreibung

Non-Fasting Glucose: Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347359
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C2826633
Pregnancy Test (betaHCG)
Beschreibung

Pregnancy Test (betaHCG)

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Beschreibung

Pregnancy Test

Datentyp

integer

Alias
UMLS CUI [1]
C0032976
If YES, what type of pregnancy was performed?
Beschreibung

Type of Pregnancy Test

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0332307
If YES, Date of Test:
Beschreibung

Date of Pregnancy Test

Datentyp

date

Maßeinheiten
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
If YES, Result:
Beschreibung

Pregnancy Test Finding

Datentyp

integer

Alias
UMLS CUI [1]
C0427777
Screening 12-Lead Electrocardiogram Report (Originial ECGs must be kept in the patient medical charts.)
Beschreibung

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

Alias
UMLS CUI-1
C0430456
ECG performed?
Beschreibung

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 and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Datentyp

text

Actual Time of ECG reading (24-hour clock)
Beschreibung

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 and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Datentyp

time

Maßeinheiten
  • 24hr:min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
24hr:min
Heart Rate
Beschreibung

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 and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Datentyp

float

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R Interval
Beschreibung

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 and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS Interval
Beschreibung

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 and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C0520880
sec
QTc Interval
Beschreibung

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 and III) and Goldberger (aVR, aVL, aVF), and six precordial leads (V1-V6), according to Wilson will be used. Heart rate (HR) and P-R, QRS, and QTc intervals will be assessed. The occurence of de- or repolarization disorders, arrhythmic disorders, or other abnormalities will also be assessed as per exclusion criteria 1 and 2.

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C0855331
sec
Overall ECG Results
Beschreibung

ECG Finding

Datentyp

text

Alias
UMLS CUI [1]
C0438154
Overall ECG Result: If abnormal - clinically significant, describe:
Beschreibung

ECG Finding: Clinically Significant

Datentyp

text

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C2826633
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 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])
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])
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])
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
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
Physical Examination
C0031809 (UMLS CUI-1)
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])
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])
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])
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])
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])
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])
Item
7. Neurological:
integer
C0027853 (UMLS CUI [1])
Neurological Examination
Code List
7. Neurological:
CL Item
Abnormal (2)
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)
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])
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])
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])
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])
Item Group
Pregnancy Test (betaHCG)
C0032976 (UMLS CUI-1)
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)
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])
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)
Item Group
Screening 12-Lead Electrocardiogram Report (Originial ECGs must be kept in the patient medical charts.)
C0430456 (UMLS CUI-1)
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])
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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