Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
age
Item
1. Is the subject aged 30 years or greater at screening visit?
boolean
C0001779 (UMLS CUI [1])
Item
2. If the subject is a female of childbearing potential, is the subject practising a clinically accepted method of contraception during the study and for at least one month prior to Day 1, and one month following completion of the study? Acceptable contraceptive methods include oral contraception, surgical sterilisation, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom in the male partner, or systemic contraception (e.g., Norplant System).
text
C0700589 (UMLS CUI [1])
Code List
2. If the subject is a female of childbearing potential, is the subject practising a clinically accepted method of contraception during the study and for at least one month prior to Day 1, and one month following completion of the study? Acceptable contraceptive methods include oral contraception, surgical sterilisation, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom in the male partner, or systemic contraception (e.g., Norplant System).
idiopathic Parkinson Disease
Item
3. Has the subject a diagnosis of idiopathic Parkinson’s Disease according to modified Hoehn & Yahr Stage I-III?
boolean
C0865475 (UMLS CUI [1])
informed consent; concomitant medication
Item
4. Has the subject provided written infomed consent prior to performing any Screening assessments, including any washout of concomitant medications in preparation for this study?
boolean
C0021430 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
comorbidity Mental disorders Hematological Disease
Item
1. Has the subject a presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neuological (other than Parkinson’s Disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident (CVA), or active malignancy (other than basal cell cancer)?
boolean
C0009488 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0018939 (UMLS CUI [1,3])
Laboratory test result abnormal aspartate aminotransferase serum creatinine
Item
2. Has the subject an aspartate aminotransferase (ALT), alanine aminotransferase (ALT), or serum creatinine >2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at screening?
boolean
C0438215 (UMLS CUI [1,1])
C0004002 (UMLS CUI [1,2])
C0201976 (UMLS CUI [1,3])
Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV Seropositivity
Item
3. Has the subject positive results for serum Hepatitis B surface antigen, Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody?
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
syncope; orthostatic hypotension; Blood pressure
Item
4. Has the subject a resent history (within the last 6 months) of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the semi-supine to standing posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure?
boolean
C0039070 (UMLS CUI [1])
C0020651 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
sleep disorder
Item
5. Has the subject a significant sleep disorder or screening Epworth Sleep Score ≥ 9?
boolean
C0851578 (UMLS CUI [1])
blood pressure
Item
6. Has the subject a diastolic blood pressure ≥110 mmHg or ≤50 mmHg OR systolic blood pressure ≥180 mmHg or ≤90 mmHg at pre-dose?
boolean
C0005823 (UMLS CUI [1])
L-dopa preparation
Item
7. Is the subject currently receiving any L-dopa preparation? (L-dopa treatment must be discontinued for at least a 2-week wash-out period prior to dosing with study medication)
boolean
C0023570 (UMLS CUI [1])
concomitant medication dopaminergic agonists
Item
8. Has the subject a history of any dopaminergic treatments within 2 weeks prior to dosing with study medication? (Note: Patients on dopaminergic agonists may be enrolled if the agent is stopped for a 2-week wash-out period prior to dosing with study medication. Patients on selegiline, amantadine,or anticholinergics may be erolled but must remain on their current dose during study participation).
boolean
C2347852 (UMLS CUI [1,1])
C0178601 (UMLS CUI [1,2])
Item
9. Has the subject a history of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT or fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 14 days prior to dosing with study medication? If yes, patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to dosing with study medication through the end of the down-titration portion of the Treatment Period. ( If this is applicable please tick N/A box and complete prior medication page)
text
C2347852 (UMLS CUI [1,1])
C0207509 (UMLS CUI [1,2])
Code List
9. Has the subject a history of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT or fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 14 days prior to dosing with study medication? If yes, patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to dosing with study medication through the end of the down-titration portion of the Treatment Period. ( If this is applicable please tick N/A box and complete prior medication page)
adverse event ropinirole
Item
10. Has the subject definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure?
boolean
C0877248 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
adverse event Dopaminergic Agents dyskinesias
Item
11. Has the subject had previous dose related AE’s to dopaminergic agents, or adverse events related to dyskinesias?
boolean
C0877248 (UMLS CUI [1,1])
C0013036 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
concomitant medication
Item
12. Has the subject had use of any investigational drug (with the exception of ropinirole CR) within the 30 days or 5 half-lives (whichever is longer) before the start of study medication dosing?
boolean
C2347852 (UMLS CUI [1])
blood donation; Hemorrhage
Item
13. Has the subject donated blood or had a significant blood loss less than 90 days prior to dosing with study medication?
boolean
C0005794 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
substance abuse disorders
Item
14. Has the subject a recent history (within the last 6 months), or suspicion, of drug dependence or abuse of alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women)? One unit is equivalent to half a pint of beer, one measure of spirts or one glass of wine
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status
Item
15. Is there significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures?
boolean
C2348568 (UMLS CUI [1])
pregnancy; lactating
Item
16. Is the subject a female who is pregnant or breast-feeding?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])