prescribed medications
Item
Has the subject refrained from taking any prescribed medications for at least 14 days and OTC medication for at least 7 days prior to the clinic visit?
boolean
C3166216 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
alcohol consumption
Item
Has the patient refrained from consuming alcohol for 48 hours before day 1?
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
xanthine-containing beverages and foods
Item
Has the subject refrained from consuming xanthine-containing beverages and foods and quinine-containing products for 48 hours before day -1?
boolean
C0043314 (UMLS CUI [1,1])
C0016452 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
daily alcohol consumption
Item
Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
poppy seed-containing food
Item
Has the subject refrained from consuming poppy seed-containing food during the 3 days prior to their visit?
boolean
C0453264 (UMLS CUI [1,1])
C0016452 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
strenuous exercise
Item
Has the patient refrained from strenuous exercise from 48 hours prior to their visit?
boolean
C1514989 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
concomitant medications
Item
For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
boolean
C2347852 (UMLS CUI [1,1])
C3850050 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
C3850068 (UMLS CUI [2])
pregnancy test
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
reason pregnancy test not done
Item
Was a pregnancy test carried out? If No, please specify reason
text
C0032976 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Pregnancy test result
Date of sampling
Item
Date of sampling
date
C0870078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0202274 (UMLS CUI [2])
Time of sampling
Item
Time of sampling
time
C0870078 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0202274 (UMLS CUI [2])
contra-indicated drugs detected
Item
Were there any contra-indicated drugs detected?
boolean
C1511790 (UMLS CUI [1,1])
C4036061 (UMLS CUI [1,2])
Type of drug
Item
Type of drug
text
C4036061 (UMLS CUI [1,1])
C0457591 (UMLS CUI [1,2])
drug
Item
Comment
text
C4036061 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Alcohol Breath Test
Item
Was an alcohol breath test carried out?
boolean
C0202306 (UMLS CUI [1])
reason alcohol breath test not done
Item
Was an alcohol breath test carried out? If "NO", please specify reason
text
C0202306 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Date of alcohol breath test
Item
Date of alcohol breath test
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Result alcohol breath test
Item
Result alcohol breath test
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Date
Item
Date of vital sign measurement
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time
Item
Time of vital sign measurement
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
systolic Blood pressure
Item
Blood pressure - supine, systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
diastolic blood pressure
Item
Blood pressure - supine, diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate supine
Item
Heart rate - supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
systolic Blood pressure erect
Item
Blood pressure - erect, systolic
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
diastolic Blood pressure erect
Item
Blood pressure - erect, diastolic
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate erect
Item
Heart rate - erect
integer
C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
morning meal
Item
Was morning meal/snack eaten before dosing?
boolean
C2698559 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Meal finish date
Item
Meal finish date
date
C2698559 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Meal finish time
Item
Meal finish time
time
C2698559 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of study medication dosing
Item
Date of study medication dosing
date
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of study medication dosing
Item
Time of study medication dosing
time
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Container Number
Item
Container Number
text
C0180098 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Regimen
text
C1276413 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
CL Item
Ropinirole CR 1mg (1 tablet) (A)
CL Item
Ropinirole CR 1+1mg (2 tablets) (B)
CL Item
Ropinirole CR 2mg (1 tablet) (C)
CL Item
Ropinirole CR 1+1+1mg (3 tablets) (D)
CL Item
Ropinirole CR 3mg (1 tablet) (E)
Dose checked and administered by
Item
Dose checked and administered by
text
C0178602 (UMLS CUI [1,1])
C1621583 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C1283174 (UMLS CUI [2,2])
Dose checked and witnessed by
Item
Dose checked and witnessed by
text
C0178602 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Dose checked and administered, date
Item
Dose checked and administered, date
date
C0178602 (UMLS CUI [1,1])
C1621583 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Time Point of measurement
integer
C0518766 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
Code List
Time Point of measurement
CL Item
Study time +1hr (1)
Date
Item
Date of vital sign measurement
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time
Item
Time of vital sign measurement
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
systolic Blood pressure
Item
Blood pressure - supine, systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
diastolic blood pressure
Item
Blood pressure - supine, diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate supine
Item
Heart rate - supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
systolic Blood pressure erect
Item
Blood pressure - erect, systolic
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
diastolic Blood pressure erect
Item
Blood pressure - erect, diastolic
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate erect
Item
Heart rate - erect
integer
C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Item
Time Point administered
integer
C3469597 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Code List
Time Point administered
CL Item
Pre-dose - 1 hr (1)
Date domperidone administered
Item
Date domperidone administered
date
C0013015 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time domperidone administered
Item
Time domperidone administered
time
C0013015 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Comment
Item
Comment domperidone administered
text
C0013015 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Time relative to start of dose
integer
C0005834 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Code List
Time relative to start of dose
Date blood sample taken
Item
Date blood sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blood sample taken
Item
Time blood sample taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Sample taken
Item
Sample taken
boolean
C1277698 (UMLS CUI [1])
C0005834 (UMLS CUI [2])
Comments
Item
Comments
text
C0005834 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
Time Point
integer
C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Adverse Event
Item
Any Adverse Event?
boolean
C0877248 (UMLS CUI [1])