ID

25991

Beskrivning

PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Nyckelord

Versioner (1)
  1. 2017-10-03 2017-10-03 -
Rättsinnehavare

glaxoSmithKline

Uppladdad den

3 oktober 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Engelsk

PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulär  
Orthostatic blood pressure / Pulse - Predose
Beskrivning

Orthostatic blood pressure / Pulse - Predose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1095971
UMLS CUI-3
C0232117
UMLS CUI-4
C3812758
Date of visit
Beskrivning

For the pre-dose measurements in Part A, Day 1 of Periods 1 and 2, and Part B, Day 1 of Periods 1 and 2, 3 sets of semi-supine and erect blood pressure and pulse measurements will be taken, commencing approximately 40 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi- supine position. Three stable measurements should be recorded In this instance stable is defined as the three semi-supine diastolic measurements being within 15 mmHg of the lowest measurement. This rule also applies for the semi-supine systolic and erect systolic and diastolic measurements. A maximum of six attempts can be made to obtain measurements pre-dose. If three consecutive stable measurements of blood pressure cannot be obtained then the Investigator should contact the Medical Monitor to discuss whether the patient can be included/continue in the study.

Datatyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C3812758
Heart Rate semi-supine
Beskrivning

Heart rate Semi-Supine

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
bpm
Heart Rate standing
Beskrivning

Heart Rate standing

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C3812758
bpm
Systolic blood pressure semi-supine
Beskrivning

Systolic blood pressure semi-supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure semi-supine
Beskrivning

Diastolic blood pressure semi-supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Systolic blood pressure standing
Beskrivning

Systolic blood pressure standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure standing
Beskrivning

Diastolic blood pressure standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C1303019
UMLS CUI [1,2]
C3812758
mmHg
Pregnancy test
Beskrivning

Pregnancy test

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Beskrivning

pregnancy test

Datatyp

integer

Alias
UMLS CUI [1]
C0032976
If yes, what type of pregnancy test was performed?
Beskrivning

pregnancy test

Datatyp

integer

Alias
UMLS CUI [1]
C0032976
Date of pregnancy test
Beskrivning

Date of pregnancy test

Datatyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Result
Beskrivning

Result of pregnancy test

Datatyp

integer

Alias
UMLS CUI [1]
C0427777
Patient diary
Beskrivning

Patient diary

Alias
UMLS CUI-1
C3890583
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.
Beskrivning

Patient diary

Datatyp

text

Alias
UMLS CUI [1]
C3890583
Alcohol breath/ blood test
Beskrivning

Alcohol breath/ blood test

Alias
UMLS CUI-1
C0202304
Time
Beskrivning

Perform Alcohol Breath/Blood Test and attach printout

Datatyp

time

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0040223
Result
Beskrivning

Result of alcohol test

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C1274040
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?
Beskrivning

alcohol consumption

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0443288
Drug screening (urine)
Beskrivning

Drug screening (urine)

Alias
UMLS CUI-1
C0202274
Time
Beskrivning

Time of drug screening

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0202274
Cannabinoids
Beskrivning

Cannabinoids urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0006864
Morphine and morphine derivates
Beskrivning

Morphine and morphine derivates urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0279996
Amphetamine
Beskrivning

Amphetamine urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0002667
Barbiturates
Beskrivning

Barbiturates urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Benzodiazepines
Beskrivning

Benzodiazepines urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0005064
Cocaine
Beskrivning

Cocaine urine

Datatyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0009170
Tricyclic antidepressants
Beskrivning

Tricyclic antidepressants urine

Datatyp

integer

Alias
UMLS CUI [1]
C0003290
If positive, give further details.
Beskrivning

Urine drug screening positive specify

Datatyp

text

Alias
UMLS CUI [1,1]
C2711519
UMLS CUI [1,2]
C1521902
Concomitant medication
Beskrivning

Concomitant medication

Alias
UMLS CUI-1
C2347852
Has the subject had any changes in medication since the last study visit?
Beskrivning

If 'Yes', please document on the Concomitant Medication Report Forms.

Datatyp

integer

Alias
UMLS CUI [1]
C0580105
Have the subject's smoking habits remained unchanged?
Beskrivning

tobacco use unchanged

Datatyp

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0442739
Has the subject complied with suggested dietary restrictions?
Beskrivning

dietary restrictions

Datatyp

integer

Alias
UMLS CUI [1,1]
C0425422
UMLS CUI [1,2]
C1321605
Adverse event
Beskrivning

Adverse event

Alias
UMLS CUI-1
C0877248
Has the subject experienced any Adverse Events since the last study contact?
Beskrivning

If 'Yes', please document on the Adverse Event Report Forms.

Datatyp

integer

Alias
UMLS CUI [1]
C0877248
Standard Breakfast
Beskrivning

Standard Breakfast

Alias
UMLS CUI-1
C2698559
Breakfast started
Beskrivning

Breakfast started

Datatyp

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439659
Breakfast ended
Beskrivning

Breakfast ended

Datatyp

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0444930
Did the subject complete the breakfast?
Beskrivning

Breakfast completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0814440
UMLS CUI [1,2]
C0205197
If no, please comment:
Beskrivning

Breakfast not completed comment

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0814440
UMLS CUI [1,3]
C0205197
Study Drug Dosing
Beskrivning

Study Drug Dosing

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
Dosage given
Beskrivning

The subject will not be allowed to lie down or sleep for 4 hours after the morning dose.

Datatyp

float

Måttenheter
  • mg/day
Alias
UMLS CUI [1]
C0678766
mg/day
Dosage
Beskrivning

Dosage

Datatyp

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C3854006
Time of dosing
Beskrivning

Time of Dosing

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
24hr:min
Witness 1
Beskrivning

Witness 1

Datatyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness 2
Beskrivning

Witness 2

Datatyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date
Beskrivning

Witness date

Datatyp

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Orthostatic blood pressure / pulse measurement - post dose
Beskrivning

Orthostatic blood pressure / pulse measurement - post dose

Alias
UMLS CUI-1
C1095971
UMLS CUI-2
C0232117
UMLS CUI-3
C0439568
Time point
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Post dose
Beskrivning

Post dose

Datatyp

integer

Alias
UMLS CUI [1]
C0439568
Post dose
Beskrivning

Post dose

Datatyp

integer

Alias
UMLS CUI [1]
C0439568
Time of post dose
Beskrivning

Time post dose

Datatyp

time

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0040223
Heart Rate semi-supine
Beskrivning

Heart rate Semi-Supine

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
bpm
Heart Rate standing
Beskrivning

Heart Rate standing

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C0439568
bpm
Systolic blood pressure semi-supine
Beskrivning

Systolic blood pressure semi-supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
mmHg
Diastolic blood pressure semi-supine
Beskrivning

Diastolic blood pressure semi-supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
mmHg
Systolic blood pressure standing
Beskrivning

Systolic blood pressure standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C0439568
mmHg
Diastolic blood pressure standing
Beskrivning

Diastolic blood pressure standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C0439568
mmHg
Adverse Event - 4 hours post dosing
Beskrivning

Adverse Event - 4 hours post dosing

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439574
Has the subject experienced any Adverse Events since the time of dosing?
Beskrivning

If Yes , please document on the Adverse Event Report Forms

Datatyp

integer

Alias
UMLS CUI [1]
C0877248
Discharge
Beskrivning

Discharge

Alias
UMLS CUI-1
C0030685
Was study medication dispensed to the subject?
Beskrivning

For subjects randomized to IR formulation, please ensure sufficient medication has been dispensed and that the subject is instructed re: self administration

Datatyp

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0947323
Time of discharge from study site
Beskrivning

Discharge Time

Datatyp

time

Alias
UMLS CUI [1]
C3864299
Date of next study visit
Beskrivning

Date of next study visit

Datatyp

date

Alias
UMLS CUI [1]
C1545257
Tillbaka till toppen

Similar models

PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Orthostatic blood pressure / Pulse - Predose
C0518766 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
C3812758 (UMLS CUI-4)
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 Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test performed?
integer
C0032976 (UMLS CUI [1])
pregnancy test
Code List
Was a pregnancy test performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Item
If yes, what type of pregnancy test was performed?
integer
C0032976 (UMLS CUI [1])
pregnancy test
Code List
If yes, what type of pregnancy test was performed?
CL Item
Serum (1)
CL Item
Urine (2)
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])
Result of pregnancy test
Code List
Result
CL Item
positive (1)
CL Item
negative (2)
Item Group
Patient diary
C3890583 (UMLS CUI-1)
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])
Item Group
Alcohol breath/ blood test
C0202304 (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])
Result of alcohol test
Code List
Result
CL Item
negative (1)
CL Item
positive (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])
Item Group
Drug screening (urine)
C0202274 (UMLS CUI-1)
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])
Cannabinoids urine
Code List
Cannabinoids
CL Item
negative (1)
CL Item
positive (2)
Item
Morphine and morphine derivates
integer
C0202274 (UMLS CUI [1,1])
C0279996 (UMLS CUI [1,2])
Morphine and morphine derivates urine
Code List
Morphine and morphine derivates
CL Item
negative (1)
CL Item
positive (2)
Item
Amphetamine
integer
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Amphetamine urine
Code List
Amphetamine
CL Item
negative (1)
CL Item
positive (2)
Item
Barbiturates
integer
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Barbiturates urine
Code List
Barbiturates
CL Item
negative (1)
CL Item
positive (2)
Item
Benzodiazepines
integer
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Benzodiazepines urine
Code List
Benzodiazepines
CL Item
negative (1)
CL Item
positive (2)
Item
Cocaine
integer
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Cocaine urine
Code List
Cocaine
CL Item
negative (1)
CL Item
positive (2)
Item
Tricyclic antidepressants
integer
C0003290 (UMLS CUI [1])
Tricyclic antidepressants urine
Code List
Tricyclic antidepressants
CL Item
negative (1)
CL Item
positive (2)
Urine drug screening positive specify
Item
If positive, give further details.
text
C2711519 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Has the subject had any changes in medication since the last study visit?
integer
C0580105 (UMLS CUI [1])
changes in medication
Code List
Has the subject had any changes in medication since the last study visit?
CL Item
Yes (1)
CL Item
No (2)
Item
Have the subject's smoking habits remained unchanged?
integer
C0543414 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
tobacco use unchanged
Code List
Have the subject's smoking habits remained unchanged?
CL Item
Yes (1)
CL Item
No (2)
Item
Has the subject complied with suggested dietary restrictions?
integer
C0425422 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
dietary restrictions
Code List
Has the subject complied with suggested dietary restrictions?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any Adverse Events since the last study contact?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the last study contact?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Standard Breakfast
C2698559 (UMLS CUI-1)
Breakfast started
Item
Breakfast started
time
C2698559 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Breakfast ended
Item
Breakfast ended
time
C2698559 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
Breakfast completed
Item
Did the subject complete the breakfast?
boolean
C0814440 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
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])
Item Group
Study Drug Dosing
C0013175 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
Dosage given
Item
Dosage given
float
C0678766 (UMLS CUI [1])
Item
Dosage
integer
C0178602 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Dosage
Code List
Dosage
CL Item
CR (1)
CL Item
IR (2)
Time of Dosing
Item
Time of dosing
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 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date
Item
Witness date
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Orthostatic blood pressure / pulse measurement - post dose
C1095971 (UMLS CUI-1)
C0232117 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date of visit
Item
Time point
date
C1320303 (UMLS CUI [1])
Item
Post dose
integer
C0439568 (UMLS CUI [1])
Post dose
Code List
Post dose
CL Item
1h post dose (1)
CL Item
2h post dose (2)
CL Item
3h post dose (3)
CL Item
4h post dose (4)
Item
Post dose
integer
C0439568 (UMLS CUI [1])
Post dose
Code List
Post dose
CL Item
1h post dose (1)
CL Item
2h post dose (2)
CL Item
3h post dose (3)
CL Item
4h post dose (4)
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 Group
Adverse Event - 4 hours post dosing
C0877248 (UMLS CUI-1)
C0439574 (UMLS CUI-2)
Item
Has the subject experienced any Adverse Events since the time of dosing?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the time of dosing?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Discharge
C0030685 (UMLS CUI-1)
Item
Was study medication dispensed to the subject?
integer
C3854006 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Study medication dispensed
Code List
Was study medication dispensed to the subject?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
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])
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