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25881

Beskrivning

Physical Examination, Laboratory, Parkinson's disease history - 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

Nyckelord

Versioner (2)
  1. 2017-09-24 2017-09-24 -
  2. 2017-09-24 2017-09-24 -
Rättsinnehavare

glaxoSmithKline

Uppladdad den

24 september 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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    Physical Examination, Laboratory, Parkinson's disease history - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    Engelsk

    Physical Examination, Laboratory, Parkinson's disease history - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

    1 Formulär  
    Physical examination
    Beskrivning

    Physical examination

    Alias
    UMLS CUI-1
    C0031809
    Height
    Beskrivning

    Height

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0005890
    Height Unit
    Beskrivning

    Height unit

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0005890
    UMLS CUI [1,2]
    C0439148
    Weight
    Beskrivning

    Weight

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0005910
    Weight Unit
    Beskrivning

    Weight Unit

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0005910
    UMLS CUI [1,2]
    C0439148
    Body Mass Index
    Beskrivning

    BMI

    Datatyp

    float

    Måttenheter
    • kg/m2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m2
    Physical examination
    Beskrivning

    Physical examination

    Alias
    UMLS CUI-1
    C0031809
    Body system
    Beskrivning

    Body system

    Datatyp

    integer

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

    Body system abnormality

    Datatyp

    integer

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

    Describe abnormality body system

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0459424
    UMLS CUI [1,2]
    C0031809
    UMLS CUI [1,3]
    C0678257
    Hematology Laboratory evaluation
    Beskrivning

    Hematology Laboratory evaluation

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0200627
    Serum Laboratory not done
    Beskrivning

    Serum Laboratory evaluation

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0229671
    Date of Sample
    Beskrivning

    Date of Sample

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Hematology Laboratory evaluation
    Beskrivning

    Hematology Laboratory evaluation

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0200627
    Analyte
    Beskrivning

    Analyte

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0443354
    Result
    Beskrivning

    laboratory Result

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0587081
    Unit
    Beskrivning

    Unit laboratory result

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519795
    Clinical significant
    Beskrivning

    Clinical significant result

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0750502
    Serum Laboratory evaluation
    Beskrivning

    Serum Laboratory evaluation

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0229671
    Serum Laboratory not done
    Beskrivning

    Serum Laboratory evaluation

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0229671
    Date of Sample
    Beskrivning

    Date of Sample

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Serum laboratory evaluation
    Beskrivning

    Serum laboratory evaluation

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0229671
    Analyte
    Beskrivning

    Analyte

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0443354
    Result
    Beskrivning

    laboratory Result

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0587081
    Unit
    Beskrivning

    Unit laboratory result

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519795
    Clinical significant
    Beskrivning

    Clinical significant result

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0750502
    Hepatitis screening
    Beskrivning

    Hepatitis screening

    Alias
    UMLS CUI-1
    C1445958
    Date of sample
    Beskrivning

    Date of sample

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0019158
    Hepatitis B surface antigen (HBsAG)
    Beskrivning

    Hepatitis B surface antigen

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0019168
    Hepatitis C antibody
    Beskrivning

    Hepatitis C antibody

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0201487
    HIV screening
    Beskrivning

    HIV screening

    Alias
    UMLS CUI-1
    C0459958
    Date of sample
    Beskrivning

    Date of sample

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0459958
    Result of Human Immunodefiency Virus Antibody (ELISA)
    Beskrivning

    Human Immunodefiency Virus Antibody

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1321876
    UMLS CUI [1,2]
    C0201388
    Urinalysis
    Beskrivning

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Date of examination
    Beskrivning

    Date of urinalysis

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0011008
    Time
    Beskrivning

    Time of urinalysis

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0040223
    Dip stick analysis
    Beskrivning

    Dip stick analysis

    Alias
    UMLS CUI-1
    C1160927
    pH value
    Beskrivning

    pH urine

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0042044
    Protein
    Beskrivning

    If positive for blood or protein, please perform microscopic analysis

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0430371
    Glucose
    Beskrivning

    Urine glucose

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0430376
    Bilirubin
    Beskrivning

    Urine bilirubin

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0430374
    Blood
    Beskrivning

    If positive for blood or protein, please perform microscopic analysis

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0430372
    microscopic analysis
    Beskrivning

    If positive for blood or protein, please perform microscopic analysis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0430397
    Microscopic analysis
    Beskrivning

    Microscopic analysis

    Alias
    UMLS CUI-1
    C0430397
    Erythrocytes
    Beskrivning

    erythrocytes urine

    Datatyp

    integer

    Måttenheter
    • cells per field
    Alias
    UMLS CUI [1]
    C2188659
    Leukocytes
    Beskrivning

    Leukocytes urine

    Datatyp

    integer

    Måttenheter
    • cells per field
    Alias
    UMLS CUI [1]
    C1254740
    Bacteria
    Beskrivning

    Bacteria urine

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1262012
    UMLS CUI [1,2]
    C0004618
    epithelia
    Beskrivning

    epithelia urine

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C3828199
    UMLS CUI [1,2]
    C1273342
    Salts
    Beskrivning

    salts urine

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0430397
    UMLS CUI [1,2]
    C0036140
    Cast
    Beskrivning

    Urine cast

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0430397
    UMLS CUI [1,2]
    C0151990
    Other
    Beskrivning

    Microscopic urinalysis other

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0430397
    UMLS CUI [1,2]
    C0205394
    Overall urinalysis assessment
    Beskrivning

    Overall urinalysis assessment

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C1274040
    Overall urinalysis assessment
    Beskrivning

    Overall urinalysis assessment

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C1274040
    If abnormal - clinically significant, describe
    Beskrivning

    Urinalysis abnormal specify

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0438142
    UMLS CUI [1,2]
    C1521902
    Alcohol breath/ blood test
    Beskrivning

    Alcohol breath/ blood test

    Alias
    UMLS CUI-1
    C0202304
    Date of examination
    Beskrivning

    Date of alcohol test

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0202304
    UMLS CUI [1,2]
    C0011008
    Time
    Beskrivning

    Time of alcohol test

    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
    Date of examination
    Beskrivning

    Date of drug screening

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C0011008
    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
    Smoking history
    Beskrivning

    Smoking history

    Alias
    UMLS CUI-1
    C1519384
    Smoker
    Beskrivning

    Smoker

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0543414
    Number of cigarettes per day.
    Beskrivning

    cigarettes per day

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3694146
    Number of cigars per day.
    Beskrivning

    cigars per day

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0678446
    UMLS CUI [1,2]
    C0439505
    Number of pipes per day.
    Beskrivning

    pipes per day

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0337665
    UMLS CUI [1,2]
    C0439505
    Epworth sleep scale (ESS)
    Beskrivning

    Epworth sleep scale (ESS)

    Alias
    UMLS CUI-1
    C3541276
    Epworth sleep scale (ESS)
    Beskrivning

    EPWORTH SLEEP SCALE (ESS) This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3541276
    Hoehn and Yahr stage
    Beskrivning

    Hoehn and Yahr stage

    Alias
    UMLS CUI-1
    C3639483
    Indicate the patient's baseline Hoehn & Yahr Stage by ticking the appropriate box below:
    Beskrivning

    Hoehn & Yahr Stage

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3639483
    Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to screening
    Beskrivning

    strenuous activity

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1514989
    Prior medications for treatment of Parkinson's disease
    Beskrivning

    Prior medications for treatment of Parkinson's disease

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-2
    C0030567
    Medication
    Beskrivning

    Use generic name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0592502
    Date started
    Beskrivning

    Medication date started

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Date stopped
    Beskrivning

    Medication date stopped

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Continuing
    Beskrivning

    Medication continuous

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Dose and frequency
    Beskrivning

    e.g. 10mg tid

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C3476109
    Route
    Beskrivning

    Route of drug administration

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0013153
    Please, specify other route.
    Beskrivning

    Specify other route

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0013153
    Tillbaka till toppen

    Similar models

    Physical Examination, Laboratory, Parkinson's disease history - 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
    Physical examination
    C0031809 (UMLS CUI-1)
    Height
    Item
    Height
    float
    C0005890 (UMLS CUI [1])
    Item
    Height Unit
    integer
    C0005890 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    Height unit
    Code List
    Height Unit
    CL Item
    in (1)
    CL Item
    cm (2)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item
    Weight Unit
    integer
    C0005910 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    Weight Unit
    Code List
    Weight Unit
    CL Item
    lb (1)
    CL Item
    kg (2)
    BMI
    Item
    Body Mass Index
    float
    C1305855 (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])
    Body system
    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
    Hematopoietic and lymphatic (9)
    CL Item
    Endocrine and metabolic (10)
    CL Item
    other (11)
    Item
    Body system abnormality
    integer
    C0460002 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Body system abnormality
    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
    Hematology Laboratory evaluation
    C0022885 (UMLS CUI-1)
    C0200627 (UMLS CUI-2)
    Serum Laboratory evaluation
    Item
    Serum Laboratory not done
    boolean
    C0022885 (UMLS CUI [1,1])
    C0229671 (UMLS CUI [1,2])
    Date of Sample
    Item
    Date of Sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Hematology Laboratory evaluation
    C0022885 (UMLS CUI-1)
    C0200627 (UMLS CUI-2)
    Item
    Analyte
    integer
    C0443354 (UMLS CUI [1])
    Analyte
    Code List
    Analyte
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Urea (3)
    CL Item
    Creatinine (4)
    CL Item
    Protein, total (5)
    CL Item
    Albumin (6)
    CL Item
    Globulin (7)
    CL Item
    Bilirubin, total (8)
    CL Item
    AST (SGOT) (9)
    CL Item
    ALT (SGPT) (10)
    CL Item
    Alkaline phosphatase (11)
    CL Item
    Calcium (12)
    CL Item
    Phosphate (13)
    CL Item
    Glucose (non-fasting) (14)
    CL Item
    GGT (15)
    CL Item
    Cholesterol (16)
    CL Item
    Triglycerides (17)
    CL Item
    Creatine phosphokinase (18)
    laboratory Result
    Item
    Result
    text
    C0587081 (UMLS CUI [1])
    Unit laboratory result
    Item
    Unit
    text
    C1519795 (UMLS CUI [1])
    Clinical significant result
    Item
    Clinical significant
    boolean
    C0456984 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Item Group
    Serum Laboratory evaluation
    C0022885 (UMLS CUI-1)
    C0229671 (UMLS CUI-2)
    Serum Laboratory evaluation
    Item
    Serum Laboratory not done
    boolean
    C0022885 (UMLS CUI [1,1])
    C0229671 (UMLS CUI [1,2])
    Date of Sample
    Item
    Date of Sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Serum laboratory evaluation
    C0022885 (UMLS CUI-1)
    C0229671 (UMLS CUI-2)
    Item
    Analyte
    integer
    C0443354 (UMLS CUI [1])
    Analyte
    Code List
    Analyte
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Urea (3)
    CL Item
    Creatinine (4)
    CL Item
    Protein, total (5)
    CL Item
    Albumin (6)
    CL Item
    Globulin (7)
    CL Item
    Bilirubin, total (8)
    CL Item
    AST (SGOT) (9)
    CL Item
    ALT (SGPT) (10)
    CL Item
    Alkaline phosphatase (11)
    CL Item
    Calcium (12)
    CL Item
    Phosphate (13)
    CL Item
    Glucose (non-fasting) (14)
    CL Item
    GGT (15)
    CL Item
    Cholesterol (16)
    CL Item
    Triglycerides (17)
    CL Item
    Creatine phosphokinase (18)
    laboratory Result
    Item
    Result
    text
    C0587081 (UMLS CUI [1])
    Unit laboratory result
    Item
    Unit
    text
    C1519795 (UMLS CUI [1])
    Clinical significant result
    Item
    Clinical significant
    boolean
    C0456984 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Item Group
    Hepatitis screening
    C1445958 (UMLS CUI-1)
    Date of sample
    Item
    Date of sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0019158 (UMLS CUI [1,3])
    Item
    Hepatitis B surface antigen (HBsAG)
    integer
    C0019168 (UMLS CUI [1])
    Hepatitis B surface antigen
    Code List
    Hepatitis B surface antigen (HBsAG)
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Hepatitis C antibody
    integer
    C0201487 (UMLS CUI [1])
    Hepatitis C antibody
    Code List
    Hepatitis C antibody
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    HIV screening
    C0459958 (UMLS CUI-1)
    Date of sample
    Item
    Date of sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0459958 (UMLS CUI [1,3])
    Item
    Result of Human Immunodefiency Virus Antibody (ELISA)
    integer
    C1321876 (UMLS CUI [1,1])
    C0201388 (UMLS CUI [1,2])
    Human Immunodefiency Virus Antibody
    Code List
    Result of Human Immunodefiency Virus Antibody (ELISA)
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Date of urinalysis
    Item
    Date of examination
    date
    C0042014 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of urinalysis
    Item
    Time
    time
    C0042014 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Dip stick analysis
    C1160927 (UMLS CUI-1)
    pH urine
    Item
    pH value
    float
    C0042044 (UMLS CUI [1])
    Item
    Protein
    text
    C0430371 (UMLS CUI [1])
    Urine Protein
    Code List
    Protein
    CL Item
    neg  (neg)
    CL Item
    pos (pos)
    Item
    Glucose
    text
    C0430376 (UMLS CUI [1])
    Urine glucose
    Code List
    Glucose
    CL Item
    neg (neg)
    CL Item
    pos (pos)
    Item
    Bilirubin
    text
    C0430374 (UMLS CUI [1])
    Urine bilirubin
    Code List
    Bilirubin
    CL Item
    neg (neg)
    CL Item
    pos (pos)
    Item
    Blood
    text
    C0430372 (UMLS CUI [1])
    Urine blood
    Code List
    Blood
    CL Item
    neg (neg)
    CL Item
    pos (pos)
    urine microscopic analysis
    Item
    microscopic analysis
    boolean
    C0430397 (UMLS CUI [1])
    Item Group
    Microscopic analysis
    C0430397 (UMLS CUI-1)
    Item
    Erythrocytes
    integer
    C2188659 (UMLS CUI [1])
    erythrocytes urine
    Code List
    Erythrocytes
    CL Item
    0 - 3 (1)
    CL Item
    4 - 6 (2)
    CL Item
    7-10 (3)
    CL Item
    11-20 (4)
    CL Item
    >20 (5)
    Item
    Leukocytes
    integer
    C1254740 (UMLS CUI [1])
    Leukocytes urine
    Code List
    Leukocytes
    CL Item
    0 - 3 (1)
    CL Item
    4 - 6 (2)
    CL Item
    7-10 (3)
    CL Item
    11-20 (4)
    CL Item
    >20 (5)
    Item
    Bacteria
    integer
    C1262012 (UMLS CUI [1,1])
    C0004618 (UMLS CUI [1,2])
    Bacteria urine
    Code List
    Bacteria
    CL Item
    none (1)
    CL Item
    few (2)
    CL Item
    moderate (3)
    CL Item
    abundant (4)
    Item
    epithelia
    integer
    C3828199 (UMLS CUI [1,1])
    C1273342 (UMLS CUI [1,2])
    epithelia urine
    Code List
    epithelia
    CL Item
    none (1)
    CL Item
    squamous (2)
    CL Item
    round (3)
    CL Item
    other (4)
    salts urine
    Item
    Salts
    text
    C0430397 (UMLS CUI [1,1])
    C0036140 (UMLS CUI [1,2])
    Urine cast
    Item
    Cast
    text
    C0430397 (UMLS CUI [1,1])
    C0151990 (UMLS CUI [1,2])
    Microscopic urinalysis other
    Item
    Other
    text
    C0430397 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Overall urinalysis assessment
    C0042014 (UMLS CUI-1)
    C1274040 (UMLS CUI-2)
    Item
    Overall urinalysis assessment
    integer
    C0042014 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Overall urinalysis assessment
    Code List
    Overall urinalysis assessment
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    Urinalysis abnormal specify
    Item
    If abnormal - clinically significant, describe
    text
    C0438142 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Item Group
    Alcohol breath/ blood test
    C0202304 (UMLS CUI-1)
    Date of alcohol test
    Item
    Date of examination
    date
    C0202304 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    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)
    Date of drug screening
    Item
    Date of examination
    date
    C0202274 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    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
    Smoking history
    C1519384 (UMLS CUI-1)
    Item
    Smoker
    text
    C0543414 (UMLS CUI [1])
    Smoker
    Code List
    Smoker
    CL Item
    yes (1)
    CL Item
    no (2)
    cigarettes per day
    Item
    Number of cigarettes per day.
    integer
    C3694146 (UMLS CUI [1])
    cigars per day
    Item
    Number of cigars per day.
    integer
    C0678446 (UMLS CUI [1,1])
    C0439505 (UMLS CUI [1,2])
    pipes per day
    Item
    Number of pipes per day.
    integer
    C0337665 (UMLS CUI [1,1])
    C0439505 (UMLS CUI [1,2])
    Item Group
    Epworth sleep scale (ESS)
    C3541276 (UMLS CUI-1)
    Epworth sleep scale (ESS)
    Item
    Epworth sleep scale (ESS)
    text
    C3541276 (UMLS CUI [1])
    Item Group
    Hoehn and Yahr stage
    C3639483 (UMLS CUI-1)
    Item
    Indicate the patient's baseline Hoehn & Yahr Stage by ticking the appropriate box below:
    text
    C3639483 (UMLS CUI [1])
    Hoehn & Yahr Stage
    Code List
    Indicate the patient's baseline Hoehn & Yahr Stage by ticking the appropriate box below:
    CL Item
    No signs of disease (Stage 0)
    CL Item
    Unilateral disease (Stage 1)
    CL Item
    Unilateral disease plus axial involvement (Stage 1.5)
    CL Item
    Mild bilateral disease, without impairment of balance (Stage 2)
    CL Item
    Mild bilateral disease, with recovery on pull test (Stage 2.5)
    CL Item
    Mild to moderate bilateral disease: some postural instability; physically independent (Stage 3)
    CL Item
    Severe disability: still able to walk or stand unassisted  (Stage 4)
    CL Item
    Wheelchair bound or bedridden unless aided (Stage 5)
    Item
    Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to screening
    integer
    C1514989 (UMLS CUI [1])
    strenuous activity
    Code List
    Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to screening
    CL Item
    yes (1)
    CL Item
    no (2)
    Item Group
    Prior medications for treatment of Parkinson's disease
    C2826257 (UMLS CUI-1)
    C0030567 (UMLS CUI-2)
    Generic name medication
    Item
    Medication
    text
    C0013227 (UMLS CUI [1,1])
    C0592502 (UMLS CUI [1,2])
    Medication date started
    Item
    Date started
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Medication date stopped
    Item
    Date stopped
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Medication continuous
    Item
    Continuing
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Dose and frequency of medication
    Item
    Dose and frequency
    text
    C3174092 (UMLS CUI [1,1])
    C3476109 (UMLS CUI [1,2])
    Item
    Route
    integer
    C0013153 (UMLS CUI [1])
    Route of drug administration
    Code List
    Route
    CL Item
    IV  (1)
    CL Item
    PR (2)
    CL Item
    IM  (3)
    CL Item
    Sublingual  (4)
    CL Item
    PO  (5)
    CL Item
    Inhaled  (6)
    CL Item
    SC  (7)
    CL Item
    Topical (8)
    CL Item
    other (9)
    Specify other route
    Item
    Please, specify other route.
    text
    C1521902 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
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