ID

24745

Beschrijving

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

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  1. 16-08-17 16-08-17 -
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Dose strength equivalence of ropinirole CR in healthy adults Treatment Period 1 101468/219

Engels

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

1 Formulieren  
Predose Checklist
Beschrijving

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?
Beschrijving

prescribed medications

Datatype

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?
Beschrijving

alcohol consumption

Datatype

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?
Beschrijving

xanthine-containing beverages and foods

Datatype

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.)
Beschrijving

daily alcohol consumption

Datatype

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?
Beschrijving

poppy seed-containing food

Datatype

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?
Beschrijving

strenuous exercise

Datatype

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)
Beschrijving

concomitant medications

Datatype

boolean

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

Pregnancy Test

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

pregnancy test

Datatype

boolean

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

reason pregnancy test not done

Datatype

text

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

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

Datatype

date

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

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

Datatype

integer

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

Drug Screening

Alias
UMLS CUI-1
C0202274
Date of sampling
Beschrijving

Drug Screening (Urine)

Datatype

date

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

Time of sampling

Datatype

time

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

contra-indicated drugs detected

Datatype

boolean

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

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

Datatype

text

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

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

Datatype

text

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

Alcohol Breath Test

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

Alcohol Breath Test

Datatype

boolean

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

reason alcohol breath test not done

Datatype

text

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

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

Datatype

date

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

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

Datatype

text

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

Baseline Signs Ans Symptoms

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

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Center Number
Beschrijving

Center Number

Datatype

text

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

Date of Visit

Datatype

date

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

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

Datatype

boolean

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

diagnosis

Datatype

text

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

Onset Date

Datatype

date

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

Onset Time

Datatype

time

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

End Date

Datatype

date

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

End Time

Datatype

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)
Beschrijving

outcome

Datatype

text

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

event course

Datatype

text

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

Number of episodes

Datatype

integer

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

intensity

Datatype

integer

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

relationship to study procedures

Datatype

integer

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

If Yes, please record on Prior Medication form.

Datatype

boolean

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

subject withdrawn due to event

Datatype

boolean

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

Vitals Signs, Pre-Dose

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

Date

Datatype

date

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

Time

Datatype

time

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

systolic Blood pressure

Datatype

integer

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

diastolic blood pressure

Datatype

integer

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

Heart rate supine

Datatype

integer

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

systolic Blood pressure erect

Datatype

integer

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

diastolic Blood pressure erect

Datatype

integer

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

Heart rate erect

Datatype

integer

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

Dosing Details

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

morning meal

Datatype

boolean

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

Was morning meal/snack eaten before dosing?

Datatype

date

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

Was morning meal/snack eaten before dosing?

Datatype

time

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

Date of study medication dosing

Datatype

date

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

Time of study medication dosing

Datatype

time

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

Container Number

Datatype

text

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

Regimen

Datatype

text

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

Dose checked and administered by

Datatype

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
Beschrijving

Dose checked and witnessed by

Datatype

text

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

Dose checked and administered, date

Datatype

date

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

Vital Signs - Post-Dose

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

Time Point of measurement

Datatype

integer

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

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

Datatype

date

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

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

Datatype

time

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

systolic Blood pressure

Datatype

integer

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

diastolic blood pressure

Datatype

integer

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

Heart rate supine

Datatype

integer

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

systolic Blood pressure erect

Datatype

integer

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

diastolic Blood pressure erect

Datatype

integer

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

Heart rate erect

Datatype

integer

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

Domperidone Dosing Details

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

Time Point administered

Datatype

integer

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

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:

Datatype

date

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

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:

Datatype

time

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

Comment

Datatype

text

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

PK Blood Sampling

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

Time relative to start of dose

Datatype

integer

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

Date blood sample taken

Datatype

date

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

Time blood sample taken

Datatype

time

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

Sample taken

Datatype

boolean

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

Comments

Datatype

text

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

Adverse Event

Alias
UMLS CUI-1
C0877248
Time Point
Beschrijving

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.

Datatype

integer

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

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

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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