ID

44181

Description

PART B - Period 1 - 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

Keywords

  1. 10/3/17 10/3/17 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 9/20/21 9/20/21 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0

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

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

Note
Description

Note

Alias
UMLS CUI-1
C1317574
Please note that the subject must have been receiving ropinirole 8 mg daily for a minimum of 3 days prior to continuing with Part B Treatment Period 1 of this study
Description

continuation status ropinirole

Data type

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0244821
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Men or women 30 to 85 years of age, inclusive, at screening. Women of child-bearing potential must be practising a clinically accepted method of contraception (such as oral contraception, surgical sterilisation, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on the male partner, or systemic contraception [i.e. Norplant System]), during the study and for at least one month prior to randomization and one month following completion of the study.
Description

age and child-bearing potential contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1960468
UMLS CUI [1,3]
C0700589
Diagnosis of idiopathic Parkinson's disease according to modified Hoehn & Yahr Stage I-III.
Description

idiopathic Parkinson's disease Hoehn&Yahr Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0865475
UMLS CUI [1,2]
C3639483
Currently participating in the open-label ropinirole CR Study 196 or a candidate for dopaminergic therapy.
Description

study subject participation status ropinirole or candidate for dopaminergic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0244821
UMLS CUI [2]
C3267134
Have a body mass index (BMI=weight kg/height m2) within the range 19 to 33 kg x m2.
Description

bmi

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Provide written informed consent prior to performing any screening assessments, including any washout of concomitant medications in preparation for this study.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Has been taking 8mg ropinirole CR daily for at least 3 days.
Description

drug dosing ropinirole

Data type

boolean

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0678766
If any question is answered NO, was exemption approved by Medical Monitor?
Description

exemption approved

Data type

boolean

Alias
UMLS CUI [1,1]
C0585836
UMLS CUI [1,2]
C1708968
Approved by
Description

Medical monitor name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Date
Description

Date of approval

Data type

date

Alias
UMLS CUI [1]
C2346844
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Patients who have an abnormality on physical examination. A patient with clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
Description

physical examination abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0035648
Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological (other than Parkinson s disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident [CVA]), or active malignancy (other than basal cell cancer).
Description

psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5,1]
C0014130
UMLS CUI [5,2]
C0027765
UMLS CUI [6]
C0007222
UMLS CUI [7]
C0006826
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at Screening.
Description

laboratory abnormality or ECG abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0522055
Positive results for serum Hepatitis B surface antigen, Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody.
Description

Hepatitis B surface antigen, Hepatitis C antibody and HIV antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0166049
UMLS CUI [2]
C0019683
Positive results for alcohol breath test or blood test and/or urine drugs of abuse test at screening.
Description

alcohol breath test or blood test and/or urine drugs of abuse test at screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1710477
UMLS CUI [1,3]
C1167994
UMLS CUI [1,4]
C1710477
UMLS CUI [2,1]
C0451130
UMLS CUI [2,2]
C1710477
Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the supine to erect posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure.
Description

syncope or orthostatic hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020651
UMLS CUI [2,1]
C0039070
UMLS CUI [2,2]
C0262926
Significant sleep disorder or screening Epworth Sleep Score >=9.
Description

sleep disorder or Epworth Sleep Score 39

Data type

boolean

Alias
UMLS CUI [1,1]
C0851578
UMLS CUI [1,2]
C2129304
Diastolic blood pressure >110 mmHg or <50 mmHg OR systolic blood pressure >180 mmHg or <90 mmHg at baseline.
Description

Abnormal diastolic arterial pressure or abnormal systolic arterial pressure

Data type

boolean

Alias
UMLS CUI [1]
C0277888
UMLS CUI [2]
C0277883
Currently receiving any L-dopa dose or preparation.
Description

L-dopa treatment must be discontinued for at least a 2-week wash-out period prior to dosing with study medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0023570
History of any dopaminergic treatments (excluding ropinirole CR) within 2 weeks prior to enrolment.
Description

Note: Patients on dopaminergic agonists other than ropinirole CR may be enrolled if the agent is stopped for a 2-week wash-out period prior to enrolment. Patients on selegiline, amantadine, or anticholinergics may be enrolled but must have been on a stable dose for at least one month prior to study enrolment and must remain on their current dose throughout the treatment phase of the study

Data type

boolean

Alias
UMLS CUI [1,1]
C0013036
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0262926
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.
Description

hormone replacement therapy or CYP1A2 inhibitors or inducers

Data type

boolean

Alias
UMLS CUI [1]
C3850050
UMLS CUI [2]
C3850068
UMLS CUI [3]
C0282402
Blood donation or significant blood loss less than 90 days before the present study.
Description

Blood donation or significant blood loss

Data type

boolean

Alias
UMLS CUI [1]
C0005795
UMLS CUI [2]
C3163616
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
Description

personal history, or family history, of adverse reactions or hypersensitivity to ropinirole

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0244821
UMLS CUI [1,3]
C0241889
UMLS CUI [1,4]
C0559546
UMLS CUI [1,5]
C0244821
UMLS CUI [1,6]
C0241889
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0244821
UMLS CUI [2,3]
C0332119
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0244821
UMLS CUI [3,3]
C0332119
Use of any investigational drug (with the exception of ropinirole CR) within the 30 days or 5 half-lives (whichever is longer) before the start of study medication dosing.
Description

Use of any investigational drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
Description

over-the-counter (OTC) medicine

Data type

boolean

Alias
UMLS CUI [1,1]
C2709201
UMLS CUI [1,2]
C0013227
Recent history, or suspicion, of drug dependence or abuse of alcohol.
Description

With alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women. One unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine.

Data type

boolean

Alias
UMLS CUI [1,1]
C1510472
UMLS CUI [1,2]
C0085762
Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
Description

drop out of the study prematurely or requirement of prohibited concomitant medication or non compliant behaviour

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1321605
Women who are pregnant or breast-feeding
Description

pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
If any question is answered NO, was exemption approved by Medical Monitor?
Description

exemption approved

Data type

boolean

Alias
UMLS CUI [1,1]
C0585836
UMLS CUI [1,2]
C1708968
Approved by
Description

Medical monitor name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Date
Description

Date of approval

Data type

date

Alias
UMLS CUI [1]
C2346844
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Body system
Description

Body system

Data type

integer

Alias
UMLS CUI [1,1]
C1268086
UMLS CUI [1,2]
C0449913
Body system abnormality
Description

Body system abnormality

Data type

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C1704258
Describe abnormality
Description

Describe abnormality body system

Data type

text

Alias
UMLS CUI [1,1]
C0459424
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0678257
Pregnancy test
Description

Pregnancy test

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

pregnancy test

Data type

integer

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

pregnancy test

Data type

integer

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

Date of pregnancy test

Data type

date

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

Result of pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0427777
Alcohol breath/ blood test
Description

Alcohol breath/ blood test

Alias
UMLS CUI-1
C0202304
Time
Description

Perform Alcohol Breath/Blood Test and attach printout

Data type

time

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

Result of alcohol test

Data type

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?
Description

alcohol consumption

Data type

boolean

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

Drug screening (urine)

Alias
UMLS CUI-1
C0202274
Time
Description

Time of drug screening

Data type

time

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

Cannabinoids urine

Data type

integer

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

Morphine and morphine derivates urine

Data type

integer

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

Amphetamine urine

Data type

integer

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

Barbiturates urine

Data type

integer

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

Benzodiazepines urine

Data type

integer

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

Cocaine urine

Data type

integer

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

Tricyclic antidepressants urine

Data type

integer

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

Urine drug screening positive specify

Data type

text

Alias
UMLS CUI [1,1]
C2711519
UMLS CUI [1,2]
C1521902
Orthostatic blood pressure / Pulse - Predose
Description

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
Description

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.

Data type

date

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

Heart rate Semi-Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
bpm
Heart Rate standing
Description

Heart Rate standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C3812758
bpm
Systolic blood pressure semi-supine
Description

Systolic blood pressure semi-supine

Data type

integer

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

Diastolic blood pressure semi-supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Systolic blood pressure standing
Description

Systolic blood pressure standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure standing
Description

Diastolic blood pressure standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C1303019
UMLS CUI [1,2]
C3812758
mmHg
Concomitant medication
Description

Concomitant medication

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

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

Data type

integer

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

tobacco use unchanged

Data type

integer

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

dietary restrictions

Data type

integer

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

Adverse event

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

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

Data type

integer

Alias
UMLS CUI [1]
C0877248
Patient diary
Description

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.
Description

Patient diary

Data type

text

Alias
UMLS CUI [1]
C3890583
Randomization
Description

Randomization

Alias
UMLS CUI-1
C0034656
Does the subject continue to meet criteria for enrollment in Part B?
Description

study subject participation status eligibility

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013893
Subject is randomized to:
Description

Randomization

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1522541
High fat breakfast
Description

High fat breakfast

Alias
UMLS CUI-1
C2698559
UMLS CUI-2
C0521974
High fat breakfast started
Description

High fat breakfast started

Data type

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0521974
UMLS CUI [1,3]
C0439659
High fat breakfast ended
Description

The suggested time for breakfast is 20 minutes

Data type

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0521974
UMLS CUI [1,3]
C0444930
Did the subject complete the breakfast?
Description

Breakfast completed

Data type

integer

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

Breakfast not completed comment

Data type

text

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

Study Drug Dosing

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
Ropinirole 8 mg administered at:
Description

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

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
24hr:min
Witness 1
Description

Witness 1

Data type

text

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

Witness date 1

Data type

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Witness 2
Description

Witness 2

Data type

text

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

Witness date 2

Data type

date

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

Orthostatic blood pressure / pulse measurement - post dose

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

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Post dose
Description

Post dose

Data type

integer

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

Time post dose

Data type

time

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

Heart rate Semi-Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
bpm
Heart Rate standing
Description

Heart Rate standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C0439568
bpm
Systolic blood pressure semi-supine
Description

Systolic blood pressure semi-supine

Data type

integer

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

Diastolic blood pressure semi-supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
mmHg
Systolic blood pressure standing
Description

Systolic blood pressure standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C0439568
mmHg
Diastolic blood pressure standing
Description

Diastolic blood pressure standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C0439568
mmHg
Adverse Event - post dosing
Description

Adverse Event - post dosing

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439568
Has the subject experienced any Adverse Events at 4 hours post dosing?
Description

If Yes , please document on the Adverse Event Report Forms

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439574
Has the subject experienced any Adverse Events at 12 hours post dosing?
Description

If Yes , please document on the Adverse Event Report Forms

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1439442
Has the subject experienced any Adverse Events at 24 hours post dosing?
Description

If Yes , please document on the Adverse Event Report Forms

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1439477
Pharmacokinetic sampling post dosing
Description

Pharmacokinetic sampling post dosing

Alias
UMLS CUI-1
C0031328
Sample ID and specified time
Description

Sample ID and specified time

Data type

integer

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C1444698
Actual time
Description

Actual time pharmacokinetics

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Date
Description

Date sample

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1302413
Discharge
Description

Discharge

Alias
UMLS CUI-1
C0030685
Time of discharge from study site
Description

Discharge Time

Data type

time

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

Advise the subject to refrain from consuming xanthine containing beverages and foods (Coffee, tea, cola beverages, cocoa chocolate), grapefruit containing products, quinine - containing products and food containing CYP1A2-inducing constituents (Brussel sprouts, broccoli, cabbage, etc ), from 24 h before the PK evaluation day, Periods 1 and 2 in Part B, until completion of assessments 24 h afterwards

Data type

date

Alias
UMLS CUI [1]
C1545257

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Note
C1317574 (UMLS CUI-1)
continuation status ropinirole
Item
Please note that the subject must have been receiving ropinirole 8 mg daily for a minimum of 3 days prior to continuing with Part B Treatment Period 1 of this study
text
C0805733 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age and child-bearing potential contraception
Item
Men or women 30 to 85 years of age, inclusive, at screening. Women of child-bearing potential must be practising a clinically accepted method of contraception (such as oral contraception, surgical sterilisation, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on the male partner, or systemic contraception [i.e. Norplant System]), during the study and for at least one month prior to randomization and one month following completion of the study.
boolean
C0001779 (UMLS CUI [1,1])
C1960468 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
idiopathic Parkinson's disease Hoehn&Yahr Stage
Item
Diagnosis of idiopathic Parkinson's disease according to modified Hoehn & Yahr Stage I-III.
boolean
C0865475 (UMLS CUI [1,1])
C3639483 (UMLS CUI [1,2])
study subject participation status ropinirole or candidate for dopaminergic therapy
Item
Currently participating in the open-label ropinirole CR Study 196 or a candidate for dopaminergic therapy.
boolean
C2348568 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C3267134 (UMLS CUI [2])
bmi
Item
Have a body mass index (BMI=weight kg/height m2) within the range 19 to 33 kg x m2.
boolean
C1305855 (UMLS CUI [1])
informed consent
Item
Provide written informed consent prior to performing any screening assessments, including any washout of concomitant medications in preparation for this study.
boolean
C0021430 (UMLS CUI [1])
drug dosing ropinirole
Item
Has been taking 8mg ropinirole CR daily for at least 3 days.
boolean
C0244821 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
exemption approved
Item
If any question is answered NO, was exemption approved by Medical Monitor?
boolean
C0585836 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Medical monitor name
Item
Approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of approval
Item
Date
date
C2346844 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
physical examination abnormality
Item
Patients who have an abnormality on physical examination. A patient with clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
boolean
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2])
psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy
Item
Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological (other than Parkinson s disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident [CVA]), or active malignancy (other than basal cell cancer).
boolean
C0004936 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0014130 (UMLS CUI [5,1])
C0027765 (UMLS CUI [5,2])
C0007222 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
laboratory abnormality or ECG abnormalities
Item
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at Screening.
boolean
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
Hepatitis B surface antigen, Hepatitis C antibody and HIV antibody
Item
Positive results for serum Hepatitis B surface antigen, Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody.
boolean
C0019168 (UMLS CUI [1,1])
C0166049 (UMLS CUI [1,2])
C0019683 (UMLS CUI [2])
alcohol breath test or blood test and/or urine drugs of abuse test at screening
Item
Positive results for alcohol breath test or blood test and/or urine drugs of abuse test at screening.
boolean
C0202306 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
C1167994 (UMLS CUI [1,3])
C1710477 (UMLS CUI [1,4])
C0451130 (UMLS CUI [2,1])
C1710477 (UMLS CUI [2,2])
syncope or orthostatic hypotension
Item
Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the supine to erect posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure.
boolean
C0020651 (UMLS CUI [1])
C0039070 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
sleep disorder or Epworth Sleep Score 39
Item
Significant sleep disorder or screening Epworth Sleep Score >=9.
boolean
C0851578 (UMLS CUI [1,1])
C2129304 (UMLS CUI [1,2])
Abnormal diastolic arterial pressure or abnormal systolic arterial pressure
Item
Diastolic blood pressure >110 mmHg or <50 mmHg OR systolic blood pressure >180 mmHg or <90 mmHg at baseline.
boolean
C0277888 (UMLS CUI [1])
C0277883 (UMLS CUI [2])
Treatment with L-Dopa
Item
Currently receiving any L-dopa dose or preparation.
boolean
C0013227 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
History of any dopaminergic treatments
Item
History of any dopaminergic treatments (excluding ropinirole CR) within 2 weeks prior to enrolment.
boolean
C0013036 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
hormone replacement therapy or CYP1A2 inhibitors or inducers
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.
boolean
C3850050 (UMLS CUI [1])
C3850068 (UMLS CUI [2])
C0282402 (UMLS CUI [3])
Blood donation or significant blood loss
Item
Blood donation or significant blood loss less than 90 days before the present study.
boolean
C0005795 (UMLS CUI [1])
C3163616 (UMLS CUI [2])
personal history, or family history, of adverse reactions or hypersensitivity to ropinirole
Item
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
boolean
C0020517 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0559546 (UMLS CUI [1,4])
C0244821 (UMLS CUI [1,5])
C0241889 (UMLS CUI [1,6])
C0020517 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
C0332119 (UMLS CUI [2,3])
C0559546 (UMLS CUI [3,1])
C0244821 (UMLS CUI [3,2])
C0332119 (UMLS CUI [3,3])
Use of any investigational drug
Item
Use of any investigational drug (with the exception of ropinirole CR) within the 30 days or 5 half-lives (whichever is longer) before the start of study medication dosing.
boolean
C0013230 (UMLS CUI [1])
over-the-counter (OTC) medicine
Item
Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
boolean
C2709201 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
drug dependence or abuse of alcohol
Item
Recent history, or suspicion, of drug dependence or abuse of alcohol.
boolean
C1510472 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
drop out of the study prematurely or requirement of prohibited concomitant medication or non compliant behaviour
Item
Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
boolean
C2347852 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
pregnant or breast-feeding
Item
Women who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
exemption approved
Item
If any question is answered NO, was exemption approved by Medical Monitor?
boolean
C0585836 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Medical monitor name
Item
Approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of approval
Item
Date
date
C2346844 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Body system
integer
C1268086 (UMLS CUI [1,1])
C0449913 (UMLS CUI [1,2])
Code List
Body system
CL Item
General appearance and skin (1)
CL Item
Head, eyes, ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Respiratory (4)
CL Item
Abdominal and gastrointestinal (5)
CL Item
Musculoskeletal (6)
CL Item
Neurological (7)
CL Item
Genitourinary (8)
CL Item
Other (9)
Item
Body system abnormality
integer
C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Body system abnormality
CL Item
normal (1)
CL Item
abnormal (2)
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 Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test performed?
integer
C0032976 (UMLS CUI [1])
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])
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])
CL Item
positive (1)
CL Item
negative (2)
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])
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])
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])
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])
Code List
Amphetamine
CL Item
negative (1)
CL Item
positive (2)
Item
Barbiturates
integer
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Code List
Barbiturates
CL Item
negative (1)
CL Item
positive (2)
Item
Benzodiazepines
integer
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Code List
Benzodiazepines
CL Item
negative (1)
CL Item
positive (2)
Item
Cocaine
integer
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Code List
Cocaine
CL Item
negative (1)
CL Item
positive (2)
Item
Tricyclic antidepressants
integer
C0003290 (UMLS CUI [1])
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
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
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])
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])
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])
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])
Code List
Has the subject experienced any Adverse Events since the last study contact?
CL Item
Yes (1)
CL Item
No (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
Randomization
C0034656 (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)
Item Group
High fat breakfast
C2698559 (UMLS CUI-1)
C0521974 (UMLS CUI-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?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
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)
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])
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])
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)
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 Group
Adverse Event - post dosing
C0877248 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
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?
CL Item
Yes (1)
CL Item
No (2)
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?
CL Item
Yes (1)
CL Item
no (2)
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?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Pharmacokinetic sampling post dosing
C0031328 (UMLS CUI-1)
Item
Sample ID and specified time
integer
C1299222 (UMLS CUI [1,1])
C1444698 (UMLS CUI [1,2])
Code List
Sample ID and specified time
CL Item
1h (1)
CL Item
2h (2)
CL Item
4h (3)
CL Item
6h (4)
CL Item
8h (5)
CL Item
10h (6)
CL Item
12h (7)
CL Item
14h (8)
CL Item
16h (9)
CL Item
20h (10)
CL Item
24h (11)
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])
Item Group
Discharge
C0030685 (UMLS CUI-1)
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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