UNIFIED PARKINSON’S DISEASE RATING SCALE
Item
UNIFIED PARKINSON’S DISEASE RATING SCALE
text
C0030567 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
text
C0262926 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
boolean
C0262926 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
text
C0262926 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
boolean
C0262926 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
text
C0262926 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
boolean
C0262926 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
text
C0262926 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
boolean
C0262926 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
text
C0262926 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
boolean
C0262926 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
text
C0262926 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
boolean
C0262926 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
text
C0262926 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
boolean
C0262926 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
text
C0262926 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
text
C0262926 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
boolean
C0262926 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
text
C0262926 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
boolean
C0262926 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
text
C0262926 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
boolean
C0262926 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
text
C0262926 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
boolean
C0262926 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
text
C0262926 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
boolean
C0262926 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
text
C0262926 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
text
C0262926 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
boolean
C0262926 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
text
C0262926 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
boolean
C0262926 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
text
C0262926 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
boolean
C0262926 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
text
C0262926 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
Blood and lymphatic system disorders
Item
Blood and lymphatic system disorders
text
C3899485 (UMLS CUI [1,1])
C0851353 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
boolean
C3899485 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Cardiac disorders
Item
Cardiac disorders
text
C3899485 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
boolean
C3899485 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
Ear and labyrinth disorder
Item
Ear and labyrinth disorder
text
C3899485 (UMLS CUI [1,1])
C0851354 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
boolean
C3899485 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
Endocrine disorders
Item
Endocrine disorders
text
C3899485 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
boolean
C3899485 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
Eye disorders
Item
Eye disorders
text
C3899485 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
boolean
C3899485 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
Gastrointestinal disorders
Item
Gastrointestinal disorders
text
C3899485 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
boolean
C3899485 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
Hepatobiliary disorders
Item
Hepatobiliary disorders
text
C3899485 (UMLS CUI [1,1])
C0267792 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
boolean
C3899485 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
Immune system disorders
Item
Immune system disorders
text
C3899485 (UMLS CUI [1,1])
C1334156 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
Metabolism and nutrition disorders
Item
Metabolism and nutrition disorders
text
C3899485 (UMLS CUI [1,1])
C0851358 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
boolean
C3899485 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
Musculoskeletal and connective tissue disorders
Item
Musculoskeletal and connective tissue disorders
text
C3899485 (UMLS CUI [1,1])
C0263660 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
boolean
C3899485 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Neoplasms benign, malignant and unspecified
Item
Neoplasms benign, malignant and unspecified (inc. cysts and polyps)
text
C3899485 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
boolean
C3899485 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
Nervous system disorders
Item
Nervous system disorders
text
C3899485 (UMLS CUI [1,1])
C0810273 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
boolean
C3899485 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Psychiatric disorders
Item
Psychiatric disorders
text
C3899485 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
boolean
C3899485 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
Renal and urinary disorders
Item
Renal and urinary disorders
text
C3899485 (UMLS CUI [1,1])
C0042075 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
Reproductive system and breast disorders
Item
Reproductive system and breast disorders
text
C3899485 (UMLS CUI [1,1])
C0851366 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
boolean
C3899485 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
Respiratory, thoracic and mediastinal disorders
Item
Respiratory, thoracic and mediastinal disorders
text
C3899485 (UMLS CUI [1,1])
C0851355 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
boolean
C3899485 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
Skin and subcutaneous tissue disorders
Item
Skin and subcutaneous tissue disorders
text
C3899485 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
boolean
C3899485 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
Vascular disorders
Item
Vascular disorders
text
C3899485 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
Parkinson’s medication
Item
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study (excluding L-Dopa)? If Yes, record each medication on a separate line using Trade Names where possible.
boolean
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Item
Units
text
C0030567 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Item
Route
text
C0030567 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
CL Item
Intramuscular (IM)
Reason for Medication
Item
Reason for Medication
text
C0030567 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Start Date
Item
Start Date
date
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Stop Date
Item
Stop Date
date
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C0030567 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
start taking L-Dopa
Item
When did the subject first start taking L-Dopa?
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
concomitant medications
Item
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
boolean
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,4])
Total Daily Dose
Item
Total Daily Dose
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,4])
Item
Units
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Item
Route
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
CL Item
Intramuscular (IM)
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Stop Date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2347852 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Date of onset of symptoms of parkinson’s disease
Item
Date of onset of symptoms of parkinson’s disease
date
C0030567 (UMLS CUI [1,1])
Item
Hoehn and Yahr stage
integer
C4274318 (UMLS CUI [1])
Code List
Hoehn and Yahr stage
CL Item
Stage 0 No signs of disease. (1)
CL Item
Stage I Unilateral disease. (2)
CL Item
Stage I.5 Unilateral plus axial involvement. (3)
CL Item
Stage 2 Bilateral disease, without impairment of balance. (4)
CL Item
Stage 2.5 Mild Bilateral disease, with recovery on pull test. (5)
CL Item
Stage 3 Mild to moderate bilateral disease, some postural instability; physically independent. (6)
CL Item
Stage 4 Severe disability; still able to walk or stand unassisted. (7)
CL Item
Stage 5 Wheelchair bound or bedridden unless aided. (8)
surgical procedures
Item
Has the subject had any surgical procedures related to Parkinson’s disease?
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Details
Item
Details
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Details
Item
Details
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Details
Item
Details
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
age, pregnancy
Item
Men or non-pregnant/non-breast-feeding women of at least 30 years of age at screening. Women of child-bearing potential must be practising a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplant], during the study and for at least one month prior to randomisation and one month following completion of the study.
boolean
C0001779 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0021359 (UMLS CUI [1,3])
Parkinsons Disease L-dopa
Item
Diagnosis of idiopathic Parkinson’s Disease (according to modified Hoehn & Yahr criteria Stages IIIV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple on/off fluctuations)
boolean
C0030567 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
L-Dopa
Item
Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
boolean
C0023570 (UMLS CUI [1])
informed consent
Item
Provide written informed consent for this study.
boolean
C0021430 (UMLS CUI [1])
compliance
Item
Be willing and able to comply with study procedures, including diary card completion and follow-up clinic visits.
boolean
C2348568 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Late stage advanced
Item
Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinsia on their stable dose of L-dopa.
boolean
C0023570 (UMLS CUI [1,1])
C0544467 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
concomitant disease
Item
Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson’s Disease), or cardiovascular disease or active malignancy (other than basal cell cancer).
boolean
C0243087 (UMLS CUI [1])
dizziness or fainting
Item
Recent history of severe dizziness or fainting due to postural hypotension on standing.
boolean
C0020651 (UMLS CUI [1,1])
C0012833 (UMLS CUI [1,2])
C0012833 (UMLS CUI [1,3])
dementia
Item
Clinical dementia that in the judgment of the investigator would preclude assessment of the subject.
boolean
C0497327 (UMLS CUI [1])
drug abuse alcoholism
Item
Recent history or current evidence of drug abuse or alcoholism.
boolean
C0001940 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
dopamine agonist
Item
Consumption of any dopamine agonist within four weeks of the start of the study.
boolean
C0178601 (UMLS CUI [1])
hypersensitivity to ropinirole
Item
Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude longterm dosing with ropinirole CR;
boolean
C0244821 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
concomitant therapy
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through the end of the Treatment Period.
boolean
C1707479 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
C3899737 (UMLS CUI [1,3])
investigational drug
Item
Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
boolean
C0013230 (UMLS CUI [1])