continuation status ropinirole
Item
Has the subject been taking 8mg ropinirole CR daily for at least 3 days
boolean
C0678766 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
Item
Body system
integer
C1268086 (UMLS CUI [1,1])
C0449913 (UMLS CUI [1,2])
CL Item
General appearance and skin (1)
CL Item
Head, eyes, ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Abdominal and gastrointestinal (5)
CL Item
Musculoskeletal (6)
CL Item
Genitourinary (8)
Item
Body system abnormality
integer
C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Body system abnormality
CL Item
not done/ not applicable (3)
Describe abnormality body system
Item
Describe abnormality
text
C0459424 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Was a pregnancy test performed?
integer
C0032976 (UMLS CUI [1])
Code List
Was a pregnancy test performed?
Item
If yes, what type of pregnancy test was performed?
integer
C0032976 (UMLS CUI [1])
Code List
If yes, what type of pregnancy test was performed?
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C0427777 (UMLS CUI [1])
Time of alcohol test
Item
Time
time
C0202304 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Result
integer
C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
alcohol consumption
Item
Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B Has this subject consumed alcohol within the previous 24h?
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Time of drug screening
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
Item
Cannabinoids
integer
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Item
Morphine and morphine derivates
integer
C0202274 (UMLS CUI [1,1])
C0279996 (UMLS CUI [1,2])
Code List
Morphine and morphine derivates
Item
Amphetamine
integer
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Item
Barbiturates
integer
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Item
Benzodiazepines
integer
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Code List
Benzodiazepines
Item
Cocaine
integer
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Item
Tricyclic antidepressants
integer
C0003290 (UMLS CUI [1])
Code List
Tricyclic antidepressants
Urine drug screening positive specify
Item
If positive, give further details.
text
C2711519 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Item
Has the subject had any changes in medication since the last study visit?
integer
C0580105 (UMLS CUI [1])
Code List
Has the subject had any changes in medication since the last study visit?
Item
Have the subject's smoking habits remained unchanged?
integer
C0543414 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Code List
Have the subject's smoking habits remained unchanged?
Item
Has the subject complied with suggested dietary restrictions?
integer
C0425422 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Code List
Has the subject complied with suggested dietary restrictions?
Item
Has the subject experienced any Adverse Events since the last study contact?
integer
C0877248 (UMLS CUI [1])
Code List
Has the subject experienced any Adverse Events since the last study contact?
Patient diary
Item
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
text
C3890583 (UMLS CUI [1])
eligibility determination
Item
Confirm that Inclusion and Exclusion Criteria have been reviewed at this visit:
boolean
C0013893 (UMLS CUI [1])
study subject participation status eligibility
Item
Does the subject continue to meet criteria for enrollment in Part B?
boolean
C2348568 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Item
Subject is randomized to:
integer
C0034656 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
Code List
Subject is randomized to:
CL Item
Continued fast (until at least 4 hours post dosing) (1)
CL Item
High fat breakfast (2)
High fat breakfast started
Item
High fat breakfast started
time
C2698559 (UMLS CUI [1,1])
C0521974 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
High fat breakfast ended
Item
High fat breakfast ended
time
C2698559 (UMLS CUI [1,1])
C0521974 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
Item
Did the subject complete the breakfast?
integer
C0814440 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Code List
Did the subject complete the breakfast?
Breakfast not completed comment
Item
If no, please comment:
text
C0947611 (UMLS CUI [1,1])
C0814440 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Time of Dosing
Item
Ropinirole 8 mg administered at:
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Witness 1
Item
Witness 1
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date 1
Item
Witness date 1
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date 2
Item
Witness date 2
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of visit
Item
Time point
date
C1320303 (UMLS CUI [1])
Item
Post dose
integer
C0439568 (UMLS CUI [1])
CL Item
24h post dose (5)
Time post dose
Item
Time of post dose
time
C0439568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Item
Has the subject experienced any Adverse Events at 4 hours post dosing?
integer
C0877248 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
Code List
Has the subject experienced any Adverse Events at 4 hours post dosing?
Item
Has the subject experienced any Adverse Events at 12 hours post dosing?
integer
C0877248 (UMLS CUI [1,1])
C1439442 (UMLS CUI [1,2])
Code List
Has the subject experienced any Adverse Events at 12 hours post dosing?
Item
Has the subject experienced any Adverse Events at 24 hours post dosing?
integer
C0877248 (UMLS CUI [1,1])
C1439477 (UMLS CUI [1,2])
Code List
Has the subject experienced any Adverse Events at 24 hours post dosing?
Item
Sample ID and specified time
integer
C1299222 (UMLS CUI [1,1])
C1444698 (UMLS CUI [1,2])
Code List
Sample ID and specified time
Actual time pharmacokinetics
Item
Actual time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date sample
Item
Date
date
C0031328 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Discharge Time
Item
Time of discharge from study site
time
C3864299 (UMLS CUI [1])
Date of next study visit
Item
Date of next study visit
date
C1545257 (UMLS CUI [1])