ID

24745

Beschreibung

Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Parkinson Disease Documentation part: Treatment Period 1, Day 1/1-2

Stichworte

Versionen (1)
  1. 16.08.17 16.08.17 -
Hochgeladen am

16. August 2017

DOI

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Dose strength equivalence of ropinirole CR in healthy adults Treatment Period 1 101468/219

Englisch

Treatment Period 1 Dose strength equivalence of ropinirole CR in healthy adults 101468/219

1 Formulare  
Predose Checklist
Beschreibung

Predose Checklist

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C1707357
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?
Beschreibung

prescribed medications

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3166216
UMLS CUI [1,2]
C0443288
Has the patient refrained from consuming alcohol for 48 hours before day 1?
Beschreibung

alcohol consumption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0443288
Has the subject refrained from consuming xanthine-containing beverages and foods and quinine-containing products for 48 hours before day -1?
Beschreibung

xanthine-containing beverages and foods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043314
UMLS CUI [1,2]
C0016452
UMLS CUI [1,3]
C0443288
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.)
Beschreibung

daily alcohol consumption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0443288
Has the subject refrained from consuming poppy seed-containing food during the 3 days prior to their visit?
Beschreibung

poppy seed-containing food

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0453264
UMLS CUI [1,2]
C0016452
UMLS CUI [1,3]
C0443288
Has the patient refrained from strenuous exercise from 48 hours prior to their visit?
Beschreibung

strenuous exercise

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514989
UMLS CUI [1,2]
C0443288
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)
Beschreibung

concomitant medications

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3850050
UMLS CUI [1,3]
C0443288
UMLS CUI [2]
C3850068
Pregnancy Test
Beschreibung

Pregnancy Test

Alias
UMLS CUI-1
C0032976
UMLS CUI-2
C0032961
Was a pregnancy test carried out?
Beschreibung

pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1]
C0032976
Was a pregnancy test carried out? If No, please specify reason
Beschreibung

reason pregnancy test not done

Datentyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0392360
Date of pregnancy test
Beschreibung

Was a pregnancy test carried out? If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test result
Beschreibung

Was a pregnancy test carried out? If Yes, please specify If ’Positive’, withdraw the subject from the study.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Drug Screening
Beschreibung

Drug Screening

Alias
UMLS CUI-1
C0202274
Date of sampling
Beschreibung

Drug Screening (Urine)

Datentyp

date

Alias
UMLS CUI [1,1]
C0870078
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0202274
Time of sampling
Beschreibung

Time of sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0870078
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0202274
Were there any contra-indicated drugs detected?
Beschreibung

contra-indicated drugs detected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C4036061
Type of drug
Beschreibung

Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.

Datentyp

text

Alias
UMLS CUI [1,1]
C4036061
UMLS CUI [1,2]
C0457591
Comment
Beschreibung

Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.

Datentyp

text

Alias
UMLS CUI [1,1]
C4036061
UMLS CUI [1,2]
C0947611
Alcohol Breath Test
Beschreibung

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Was an alcohol breath test carried out?
Beschreibung

Alcohol Breath Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0202306
Was an alcohol breath test carried out? If "NO", please specify reason
Beschreibung

reason alcohol breath test not done

Datentyp

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0392360
Date of alcohol breath test
Beschreibung

Was an alcohol breath test carried out? If "YES", please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
Result alcohol breath test
Beschreibung

Was an alcohol breath test carried out? If "YES", please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
Baseline Signs Ans Symptoms
Beschreibung

Baseline Signs Ans Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Center Number
Beschreibung

Center Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Baseline Sign/Symptom
Beschreibung

Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to subject: “How do you feel?” Provide the diagnosis, NOT symptoms where possible. (One baseline event per column) If no baseline events experienced, please mark box NO and sign form below

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
Baseline Sign/Symptom
Beschreibung

diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C1442488
Onset Date
Beschreibung

Onset Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0808070
Onset Time
Beschreibung

Onset Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0449244
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0806020
End Time
Beschreibung

End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1522314
Outcome (If subject dies, please inform GSK within 24 hours and complete form D)
Beschreibung

outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0011900
Event Course
Beschreibung

event course

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C0011900
Event Course, if intermittent, Number of episodes
Beschreibung

Number of episodes

Datentyp

integer

Alias
UMLS CUI [1,1]
C4086638
UMLS CUI [1,2]
C0011900
Intensity
Beschreibung

intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0011900
Relationship to study procedures performed prior to randomisation
Beschreibung

relationship to study procedures

Datentyp

integer

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C0011900
Corrective Therapy
Beschreibung

If Yes, please record on Prior Medication form.

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0011900
Was subject withdrawn due to this event?
Beschreibung

subject withdrawn due to event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0877248
Vitals Signs, Pre-Dose
Beschreibung

Vitals Signs, Pre-Dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Date of vital sign measurement
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Time of vital sign measurement
Beschreibung

Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure - supine, systolic
Beschreibung

systolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood pressure - supine, diastolic
Beschreibung

diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate - supine
Beschreibung

Heart rate supine

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
Blood pressure - erect, systolic
Beschreibung

systolic Blood pressure erect

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Blood pressure - erect, diastolic
Beschreibung

diastolic Blood pressure erect

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Heart rate - erect
Beschreibung

Heart rate erect

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
beats/min
Dosing Details
Beschreibung

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Was morning meal/snack eaten before dosing?
Beschreibung

morning meal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439565
Meal finish date
Beschreibung

Was morning meal/snack eaten before dosing?

Datentyp

date

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0011008
Meal finish time
Beschreibung

Was morning meal/snack eaten before dosing?

Datentyp

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0040223
Date of study medication dosing
Beschreibung

Date of study medication dosing

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of study medication dosing
Beschreibung

Time of study medication dosing

Datentyp

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Container Number
Beschreibung

Container Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0180098
UMLS CUI [1,2]
C0013227
Regimen
Beschreibung

Regimen

Datentyp

text

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0013227
Dose checked and administered by
Beschreibung

Dose checked and administered by

Datentyp

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1621583
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C1283174
Dose checked and witnessed by
Beschreibung

Dose checked and witnessed by

Datentyp

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1283174
Dose checked and administered, date
Beschreibung

Dose checked and administered, date

Datentyp

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1621583
UMLS CUI [1,3]
C0011008
Vital Signs - Post-Dose
Beschreibung

Vital Signs - Post-Dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
Time Point of measurement
Beschreibung

Time Point of measurement

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C2348792
Date of vital sign measurement
Beschreibung

Please measure again according to Study time: +1hr, +4hr, +6hrs, +12hrs, +24hrs, +36hrs

Datentyp

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Time of vital sign measurement
Beschreibung

Please measure again according to Study time: +1hr, +4hr, +6hrs, +12hrs, +24hrs, +36hrs

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure - supine, systolic
Beschreibung

systolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood pressure - supine, diastolic
Beschreibung

diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate - supine
Beschreibung

Heart rate supine

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
Blood pressure - erect, systolic
Beschreibung

systolic Blood pressure erect

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Blood pressure - erect, diastolic
Beschreibung

diastolic Blood pressure erect

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Heart rate - erect
Beschreibung

Heart rate erect

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
beats/min
Domperidone Dosing Details
Beschreibung

Domperidone Dosing Details

Alias
UMLS CUI-1
C0013015
UMLS CUI-2
C0178602
Time Point administered
Beschreibung

Time Point administered

Datentyp

integer

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C2348792
Date domperidone administered
Beschreibung

2 X 10 mg tablets of domperidone are to be administered at the following timepoints. Time Point: Pre-dose - 1 hr, +7 hrs, +15 hrs Please record details below:

Datentyp

date

Alias
UMLS CUI [1,1]
C0013015
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0011008
Time domperidone administered
Beschreibung

2 X 10 mg tablets of domperidone are to be administered at the following timepoints. Time Point: Pre-dose - 1 hr, +7 hrs, +15 hrs Please record details below:

Datentyp

time

Alias
UMLS CUI [1,1]
C0013015
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0040223
Comment domperidone administered
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0013015
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0947611
PK Blood Sampling
Beschreibung

PK Blood Sampling

Alias
UMLS CUI-1
C0005834
Time relative to start of dose
Beschreibung

Time relative to start of dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2348792
Date blood sample taken
Beschreibung

Date blood sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Time blood sample taken
Beschreibung

Time blood sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
Sample taken
Beschreibung

Sample taken

Datentyp

boolean

Alias
UMLS CUI [1]
C1277698
UMLS CUI [2]
C0005834
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0947611
Adverse Event
Beschreibung

Adverse Event

Alias
UMLS CUI-1
C0877248
Time Point
Beschreibung

Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis not symptoms where possible.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348792
Any Adverse Event?
Beschreibung

*If "Yes" record all details on an Adverse Event page at back of CRF.

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
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Ähnliche Modelle

Treatment Period 1 Dose strength equivalence of ropinirole CR in healthy adults 101468/219

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Predose Checklist
C0439565 (UMLS CUI-1)
C1707357 (UMLS CUI-2)
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])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
C0032961 (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])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Drug Screening
C0202274 (UMLS CUI-1)
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])
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
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])
Item Group
Baseline Signs Ans Symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Baseline Sign/Symptom
Item
Baseline Sign/Symptom
boolean
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
diagnosis
Item
Baseline Sign/Symptom
text
C0011900 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C1442488 (UMLS CUI [2,2])
Onset Date
Item
Onset Date
date
C0011900 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Onset Time
Item
Onset Time
time
C0011900 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0011900 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time
Item
End Time
time
C0011900 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Outcome (If subject dies, please inform GSK within 24 hours and complete form D)
text
C1547647 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
outcome
Code List
Outcome (If subject dies, please inform GSK within 24 hours and complete form D)
CL Item
Resolved (R)
CL Item
Ongoing (O)
CL Item
Died (D)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
event course
Code List
Event Course
CL Item
Intermittent (I)
CL Item
Constant (C)
Number of episodes
Item
Event Course, if intermittent, Number of episodes
integer
C4086638 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Intensity
integer
C0518690 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to study procedures performed prior to randomisation
integer
C1510821 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
relationship to study procedures
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (3)
CL Item
Probable (4)
corrective therapy
Item
Corrective Therapy
boolean
C0087111 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
subject withdrawn due to event
Item
Was subject withdrawn due to this event?
boolean
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Vitals Signs, Pre-Dose
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-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])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-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])
Regimen
Code List
Regimen
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 Group
Vital Signs - Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Time Point of measurement
integer
C0518766 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
Time Point of measurement
Code List
Time Point of measurement
CL Item
Study time +1hr (1)
CL Item
+4hr (2)
CL Item
+6hrs (3)
CL Item
+12hrs (4)
CL Item
+24hrs (5)
CL Item
+36hrs (6)
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 Group
Domperidone Dosing Details
C0013015 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Item
Time Point administered
integer
C3469597 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Time Point administered
Code List
Time Point administered
CL Item
Pre-dose - 1 hr (1)
CL Item
+7 hrs (2)
CL Item
+15 hrs (3)
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 Group
PK Blood Sampling
C0005834 (UMLS CUI-1)
Item
Time relative to start of dose
integer
C0005834 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Time relative to start of dose
Code List
Time relative to start of dose
CL Item
Pre-dose (1)
CL Item
+1 hr (2)
CL Item
+2 hrs (3)
CL Item
+3 hrs (4)
CL Item
+4 hrs (5)
CL Item
+6 hrs (6)
CL Item
+8 hrs (7)
CL Item
+10 hrs (8)
CL Item
+12 hrs (9)
CL Item
+14 hrs (10)
CL Item
+16 hrs (11)
CL Item
+18 hrs (12)
CL Item
+20 hrs (13)
CL Item
+22 hrs (14)
CL Item
+24 hrs (15)
CL Item
+26 hrs (16)
CL Item
+28 hrs (17)
CL Item
+32 hrs (18)
CL Item
+36 hrs (19)
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 Group
Adverse Event
C0877248 (UMLS CUI-1)
Item
Time Point
integer
C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Time Point
Code List
Time Point
CL Item
Pre-dose (1)
CL Item
+1 hrs (2)
CL Item
+4 hrs (3)
CL Item
+6 hrs (4)
CL Item
+12 hrs (5)
CL Item
+24 hrs (6)
CL Item
+36 hrs (7)
Adverse Event
Item
Any Adverse Event?
boolean
C0877248 (UMLS CUI [1])
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