ID

43841

Description

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

Keywords

Versions (2)
  1. 10/10/17 10/10/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

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

English

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

1 forms  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient No.
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Date of Visit
Description

Date of Visit

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Clinical Global Impression
Description

Clinical Global Impression

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

Severity of Illness

Data type

integer

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

Global Improvement

Data type

integer

Alias
UMLS CUI [1]
C3639888
Study Drug Compliance
Description

Study Drug Compliance

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

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

Data type

text

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

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

Data type

text

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

Compliance

Data type

text

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

Missed Dose: Date

Data type

date

Measurement units
  • 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)
Description

Missed Dose: Tablet

Data type

text

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

Missed Dose: Dosage

Data type

float

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

Missed Dose: Reason

Data type

text

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

Study Drug Dosing

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

Prescribed Dose

Data type

float

Measurement units
  • mg/d
Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0278329
mg/d
Orthostatic Blood Pressure/ Pulse
Description

Orthostatic Blood Pressure/ Pulse

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

Time of Examination

Data type

time

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

Semi-Supine Heart Rate

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
bpm
Standing Heart Rate
Description

Erect Heart Rate

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
bpm
Semi-Supine Systolic Blood Pressure
Description

Semi-Supine Systolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-Supine Diastolic Blood Pressure
Description

Semi-Supine Diastolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
mmHg
Standing Systolic Blood Pressure
Description

Erect Systolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mmHg
Standing Diastolic Blood Pressure
Description

Erect Diastolic Blood Pressure

Data type

float

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

Unified Parkinson's Disease Rating Scale (UPDRS)

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

Unified Parkinson's Disease Rating Scale

Data type

text

Alias
UMLS CUI [1]
C3639721
Physical Examination
Description

Physical Examination

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

General Appearance and Skin

Data type

integer

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

General Appearance and Skin: Abnormality

Data type

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:
Description

ENT Examination

Data type

integer

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

ENT Examination: Abnormality

Data type

text

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

Cardiovascular Examination

Data type

integer

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

Cardiovascular Examination: Abnormality

Data type

text

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

Respiratory Examination

Data type

integer

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

Respiratory Examination: Abnormality

Data type

text

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

Abdominal Examination

Data type

integer

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

Abdominal Examination: Abnormality

Data type

text

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

Musculoskeletal Examination

Data type

integer

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

Musculoskeletal Examination: Abnormality

Data type

text

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

Neurological Examination

Data type

integer

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

Neurological Examination: Abnormality

Data type

text

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

Genitourinary Examination

Data type

integer

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

Genitourinary Examination: Abnormality

Data type

text

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

Other Examination

Data type

integer

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

Other Examination: Abnormality

Data type

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.
Description

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?
Description

Hematology

Data type

boolean

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

Hematology: Collection Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1317250
dd-mmm-yyyy
Hemoglobin: Result
Description

Hemoglobin

Data type

float

Alias
UMLS CUI [1]
C0019046
Hemoglobin: Units
Description

Hemoglobin: Unit

Data type

text

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

Hemoglobin: Clinically Significant

Data type

boolean

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

Hematocrit

Data type

float

Alias
UMLS CUI [1]
C0518014
Hematocrit: Units
Description

Hematocrit: Unit

Data type

text

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

Hematocrit: Clinically Significant

Data type

boolean

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

Red Blood Count

Data type

float

Alias
UMLS CUI [1]
C1287262
RBC: Units
Description

Red Blood Count: Unit

Data type

text

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

Red Blood Count: Clinically Significant

Data type

boolean

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

White Blood Count

Data type

float

Alias
UMLS CUI [1]
C0023508
WBC: Units
Description

White Blood Count: Unit

Data type

text

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

White Blood Count: Clinically Significant

Data type

boolean

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

Platelets

Data type

float

Alias
UMLS CUI [1]
C0005821
Platelets: Units
Description

Platelets: Unit

Data type

text

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

Platelets: Clinically Significant

Data type

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.
Description

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?
Description

Serum Chemistry

Data type

boolean

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

Serum Chemistry: Collection Date

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C1883010
UMLS CUI [1,2]
C1317250
dd-mmm-yyyy
Sodium: Result
Description

Sodium

Data type

float

Alias
UMLS CUI [1]
C0337443
Sodium: Units
Description

Sodium: Unit

Data type

text

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

Sodium: Clinically Significant

Data type

boolean

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

Potassium

Data type

float

Alias
UMLS CUI [1]
C0202194
Potassium: Units
Description

Potassium: Unit

Data type

text

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

Potassium: Clinically Significant

Data type

boolean

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

Urea

Data type

float

Alias
UMLS CUI [1]
C0523961
Urea: Units
Description

Urea: Unit

Data type

text

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

Urea: Clinically Significant

Data type

boolean

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

Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976
Creatinine: Units
Description

Creatinine: Unit

Data type

text

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

Creatinine: Clinically Significant

Data type

boolean

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

Total Protein

Data type

float

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

Total Protein: Unit

Data type

text

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

Total Protein: Clinically Significant

Data type

boolean

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

Albumin

Data type

float

Alias
UMLS CUI [1]
C0201838
Albumin: Units
Description

Albumin: Unit

Data type

text

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

Albumin: Clinically Significant

Data type

boolean

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

Globulin

Data type

float

Alias
UMLS CUI [1]
C0877347
Globulin: Units
Description

Globulin: Unit

Data type

text

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

Globulin: Clinically Significant

Data type

boolean

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

Total Bilirubin

Data type

float

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

Total Bilirubin: Unit

Data type

text

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

Total Bilirubin: Clinically Significant

Data type

boolean

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

AST

Data type

float

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

AST: Unit

Data type

text

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

AST: Clinically Significant

Data type

boolean

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

ALT

Data type

float

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

ALT: Unit

Data type

text

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

ALT: Clinically Significant

Data type

boolean

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

Alkaline Phosphatase

Data type

float

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

Alkaline Phosphatase: Unit

Data type

text

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

Alkaline Phosphatase: Clinically Significant

Data type

boolean

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

Calcium

Data type

float

Alias
UMLS CUI [1]
C0201925
Calcium: Units
Description

Calcium: Unit

Data type

text

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

Calcium: Clinically Significant

Data type

boolean

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

Phosphate

Data type

float

Alias
UMLS CUI [1]
C0523826
Phosphate: Units
Description

Phosphate: Unit

Data type

text

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

Phosphate: Clinically Significant

Data type

boolean

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

Non-Fasting Glucose

Data type

float

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

Non-Fasting Glucose: Unit

Data type

text

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

Non-Fasting Glucose: Clinically Significant

Data type

boolean

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

Pregnancy Test (betaHCG)

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

Pregnancy Test

Data type

integer

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

Type of Pregnancy Test

Data type

integer

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

Date of Pregnancy Test

Data type

date

Measurement units
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
dd-mmm-yyyy
If YES, Result:
Description

Pregnancy Test Finding

Data type

integer

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

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

Alias
UMLS CUI-1
C0430456
ECG performed?
Description

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.

Data type

text

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

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.

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
24hr:min
Heart Rate
Description

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.

Data type

float

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R Interval
Description

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.

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS Interval
Description

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.

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0520880
sec
QTc Interval
Description

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.

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0855331
sec
Overall ECG Results
Description

ECG Finding

Data type

text

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

ECG Finding: Clinically Significant

Data type

text

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C2826633
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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