Clinical Global Impression
Severity of Illness
integer
Global Improvement
integer
Study Drug Compliance
Split up in groups of 2, 3, 4 or 8 mg.
text
Split up in groups of 2, 3, 4 or 8mg.
text
Compliance
text
Missed Dose: Date
date
Missed Dose: Tablet
text
Missed Dose: Dosage
float
Missed Dose: Reason
text
Study Drug Dosing
Orthostatic Blood Pressure/ Pulse
Time of Examination
time
Semi-Supine Heart Rate
float
Erect Heart Rate
float
Semi-Supine Systolic Blood Pressure
float
Semi-Supine Diastolic Blood Pressure
float
Erect Systolic Blood Pressure
float
Erect Diastolic Blood Pressure
float
Unified Parkinson's Disease Rating Scale (UPDRS)
Physical Examination
General Appearance and Skin
integer
General Appearance and Skin: Abnormality
text
ENT Examination
integer
ENT Examination: Abnormality
text
Cardiovascular Examination
integer
Cardiovascular Examination: Abnormality
text
Respiratory Examination
integer
Respiratory Examination: Abnormality
text
Abdominal Examination
integer
Abdominal Examination: Abnormality
text
Musculoskeletal Examination
integer
Musculoskeletal Examination: Abnormality
text
Neurological Examination
integer
Neurological Examination: Abnormality
text
Genitourinary Examination
integer
Genitourinary Examination: Abnormality
text
Other Examination
integer
Other Examination: Abnormality
text
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.
Hematology
boolean
Hematology: Collection Date
date
Hemoglobin
float
Hemoglobin: Unit
text
Hemoglobin: Clinically Significant
boolean
Hematocrit
float
Hematocrit: Unit
text
Hematocrit: Clinically Significant
boolean
Red Blood Count
float
Red Blood Count: Unit
text
Red Blood Count: Clinically Significant
boolean
White Blood Count
float
White Blood Count: Unit
text
White Blood Count: Clinically Significant
boolean
Platelets
float
Platelets: Unit
text
Platelets: Clinically Significant
boolean
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.
Serum Chemistry
boolean
Serum Chemistry: Collection Date
date
Sodium
float
Sodium: Unit
text
Sodium: Clinically Significant
boolean
Potassium
float
Potassium: Unit
text
Potassium: Clinically Significant
boolean
Urea
float
Urea: Unit
text
Urea: Clinically Significant
boolean
Creatinine
float
Creatinine: Unit
text
Creatinine: Clinically Significant
boolean
Total Protein
float
Total Protein: Unit
text
Total Protein: Clinically Significant
boolean
Albumin
float
Albumin: Unit
text
Albumin: Clinically Significant
boolean
Globulin
float
Globulin: Unit
text
Globulin: Clinically Significant
boolean
Total Bilirubin
float
Total Bilirubin: Unit
text
Total Bilirubin: Clinically Significant
boolean
AST
float
AST: Unit
text
AST: Clinically Significant
boolean
ALT
float
ALT: Unit
text
ALT: Clinically Significant
boolean
Alkaline Phosphatase
float
Alkaline Phosphatase: Unit
text
Alkaline Phosphatase: Clinically Significant
boolean
Calcium
float
Calcium: Unit
text
Calcium: Clinically Significant
boolean
Phosphate
float
Phosphate: Unit
text
Phosphate: Clinically Significant
boolean
Non-Fasting Glucose
float
Non-Fasting Glucose: Unit
text
Non-Fasting Glucose: Clinically Significant
boolean
Pregnancy Test (betaHCG)
Pregnancy Test
integer
Type of Pregnancy Test
integer
Date of Pregnancy Test
date
Pregnancy Test Finding
integer
Screening 12-Lead Electrocardiogram Report (Originial ECGs must be kept in the patient medical charts.)
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.
text
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.
time
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.
float
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.
float
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.
float
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.
float
ECG Finding
text
ECG Finding: Clinically Significant
text