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ID

18598

Descrizione

A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 2

Keywords

versioni (2)
  1. 02/11/16 02/11/16 -
  2. 11/11/16 11/11/16 -
Caricato su

11 novembre 2016

DOI

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Licenza

Creative Commons BY-NC-ND 3.0
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    Visit 2 Galafold (migalastat) AT1001-012 NCT01218659

    Inglese

    Visit 2 Galafold (migalastat) AT1001-012 NCT01218659

    1 moduli  
    Date of visit
    Descrizione

    Date of visit

    Alias
    UMLS CUI-1
    C1320303
    Date of visit
    Descrizione

    Date of visit

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303
    Hematology/Coagulation
    Descrizione

    Hematology/Coagulation

    Alias
    UMLS CUI-1
    C0474523
    Hematology Sample Collection Date
    Descrizione

    Hematology Sample Collection Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0011008
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
    Descrizione

    Hematology finding; Laboratory test finding

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0587081
    Hematology: clinically significant abnormal laboratory values, please sepcify
    Descrizione

    Hematology: clinically significant abnormal laboratory values, please sepcify

    Alias
    UMLS CUI-1
    C0474523
    UMLS CUI-2
    C1853129
    UMLS CUI-3
    C2826293
    Hematology: clinically significant abnormal laboratory values, please sepcify
    Descrizione

    If lab abnormalities=Yes

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C1853129
    UMLS CUI [1,3]
    C2826293
    Chemistry, Laboratory findings
    Descrizione

    Chemistry, Laboratory findings

    Alias
    UMLS CUI-1
    C0007996
    UMLS CUI-2
    C0022885
    Chemistry Sample Collection Date
    Descrizione

    Chemistry Sample Collection Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0007996
    UMLS CUI [1,2]
    C0022877
    UMLS CUI [1,3]
    C0011008
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
    Descrizione

    Science of Chemistry; Laboratory test finding

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0007996
    UMLS CUI [1,2]
    C0587081
    Chemistry: clinically significant abnormal laboratory values, please specify
    Descrizione

    Chemistry: clinically significant abnormal laboratory values, please specify

    Alias
    UMLS CUI-1
    C0005774
    UMLS CUI-2
    C2826293
    Chemistry: clinically significant abnormal laboratory values, please specify
    Descrizione

    If lab abnormalities=Yes

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0005774
    UMLS CUI [1,2]
    C2826293
    Urinanalysis
    Descrizione

    Urinanalysis

    Alias
    UMLS CUI-1
    C0042014
    Urinalysis Sample Collection Date
    Descrizione

    Urinalysis Sample Collection Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0022877
    UMLS CUI [1,3]
    C0011008
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
    Descrizione

    Urinalysis; Laboratory test finding

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0587081
    Urinalysis: clinically significant abnormal laboratory values, please specify
    Descrizione

    Urinalysis: clinically significant abnormal laboratory values, please specify

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C1853129
    UMLS CUI-3
    C2826293
    Urinalysis: clinically significant abnormal laboratory values, please specify
    Descrizione

    If lab abnormalities=Yes

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C1853129
    UMLS CUI [1,3]
    C2826293
    24-Hr Urine Collection
    Descrizione

    24-Hr Urine Collection

    Alias
    UMLS CUI-1
    C0455060
    24-Hr Urine Collection Start Date
    Descrizione

    24-Hr Urine Collection Start Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C0808070
    24-Hr Urine Collection Start Time
    Descrizione

    24-Hr Urine Collection Start Time

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C1301880
    24-Hr Urine Collection Stop Date
    Descrizione

    24-Hr Urine Collection Stop Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C0806020
    24-Hr Urine Collection Stop Time
    Descrizione

    24-Hr Urine Collection Stop Time

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C1522314
    24-Hr Urine Collection Total Volume
    Descrizione

    24-Hr Urine Collection Total Volume

    Tipo di dati

    float

    Unità di misura
    • ml
    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C2700258
    ml
    24-Hr Urine Collection Date Sent to Laboratory
    Descrizione

    24-Hr Urine Collection Date Sent to Laboratory

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C1515023
    UMLS CUI [1,3]
    C0011008
    Additional Observations
    Descrizione

    Additional Observations

    Alias
    UMLS CUI-1
    C0700325
    Reference date
    Descrizione

    reference date

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1719096
    Visit Type
    Descrizione

    Visit

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0545082
    electronic case report form
    Descrizione

    eCRF

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1516308
    Comment
    Descrizione

    Comment

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0947611
    Vital Signs
    Descrizione

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date of Assessment
    Descrizione

    Assessment Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C2985720
    Body weight
    Descrizione

    Weight

    Tipo di dati

    float

    Unità di misura
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Blood pressure measurement systolic
    Descrizione

    Blood pressure

    Tipo di dati

    integer

    Unità di misura
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Blood pressure measurement diastolic
    Descrizione

    Blood pressure

    Tipo di dati

    integer

    Unità di misura
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Heart rate
    Descrizione

    Heart rate

    Tipo di dati

    integer

    Unità di misura
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Respiration rate, Breathing rate (BR)
    Descrizione

    Respiration Rate

    Tipo di dati

    integer

    Unità di misura
    • /min
    Alias
    UMLS CUI [1]
    C0231832
    /min
    GFR of Iohexol
    Descrizione

    GFR of Iohexol

    Alias
    UMLS CUI-1
    C0017654
    UMLS CUI-2
    C0022005
    GFR of Iohexol
    Descrizione

    GFR of Iohexol

    Tipo di dati

    float

    Alias
    UMLS CUI [1,1]
    C0017654
    UMLS CUI [1,2]
    C0022005
    Echocardiography
    Descrizione

    Echocardiography

    Alias
    UMLS CUI-1
    C0013516
    Date of echocardiography
    Descrizione

    Date echocardiography

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013516
    SF-36 Health Survey
    Descrizione

    SF-36 Health Survey

    Alias
    UMLS CUI-1
    C0451287
    Was the health survey completed?
    Descrizione

    Was the health survey completed?

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0451287
    Modified Brief Pain Inventory
    Descrizione

    Modified Brief Pain Inventory

    Date of Assessment
    Descrizione

    Assessment Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C2985720
    Please rate your pain by circling the number that best describes your pain at its worst in the past 24 hours.
    Descrizione

    pain at its worst

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0030193
    Please rate your pain by circling the number that best describes your pain at its least in the past 24 hours.
    Descrizione

    Pain at its least

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0030193
    Please rate your pain by circling the number that best describes your pain on the average
    Descrizione

    pain on average

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0030193
    Please rate your pain by circling the number that best describes how much pain you have right now.
    Descrizione

    pain right now

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0030193
    Randomization
    Descrizione

    Randomization

    Alias
    UMLS CUI-1
    C0034656
    Was the urine pregnancy test done and confirmed as negative?
    Descrizione

    cardiovascular event

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0038454
    Date of Randomization
    Descrizione

    Date of Randomization

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0011008
    Randomization Number (Received via the IVRS)
    Descrizione

    Randomization Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2986235
    Treatment
    Descrizione

    Treatment arm

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1522541
    Brain MRI
    Descrizione

    Brain MRI

    Alias
    UMLS CUI-1
    C0412675
    MRI: Date
    Descrizione

    MRI date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C0011008
    MRI Results
    Descrizione

    MRI Results

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C1274040
    MRI Abnormalities
    Descrizione

    If clinically significant: please specify any abnormal interpretation

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0024485
    Secondary Endpoint Criteria
    Descrizione

    Secondary Endpoint Criteria

    Since the last visit, did the subject have a cardiac event that meets the secondary endpoint criteria?
    Descrizione

    cardiovascular event

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1320716
    Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
    Descrizione

    cerebrovascular event

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0038454
    Enzyme Replacement Therapy
    Descrizione

    Enzyme Replacement Therapy

    Alias
    UMLS CUI-1
    C0598391
    Dosing: Record the total ERT Infusions since the last visit
    Descrizione

    Enzyme Replacement Therapy Infusion procedures Count

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0598391
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0750480
    Dosing: Were any infusions missed?
    Descrizione

    Enzyme Replacement Therapy

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0598391
    Enter Details of each infusion: Drug name
    Descrizione

    Drug name

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0013227
    Enter Details of each infusion: Date of infusion
    Descrizione

    Date of infusion

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0011008
    Enter Details of each infusion: Prescribed Dose
    Descrizione

    Prescribed Dose

    Tipo di dati

    float

    Unità di misura
    • mg/kg
    Alias
    UMLS CUI [1]
    C0678766
    mg/kg
    Enter Details of each infusion: Was the total volume infused?
    Descrizione

    infusion volume

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C2700258
    Drug log
    Descrizione

    Drug log

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0920316
    Visit Summary: Date and time of dose of last active drug
    Descrizione

    Date and time of dose of last active drug

    Tipo di dati

    text

    Visit Summary: Did the subject take all required active study drug over the last 7 days?
    Descrizione

    Did the subject take all required active study drug over the last 7 days

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0008972
    Visit Summary: Number of actives capsules the subject should have taken over the last 7 days
    Descrizione

    Number of actives capsules the subject should have taken over the last 7 days

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0006935
    Visit Summary: Number of actives capsules actually taken by the subject over the last 7 days
    Descrizione

    Number of actives capsules actually taken by the subject over the last 7 days

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0006935
    Visit Summary: If the subject was not 100% compliant when taking active drug over the last 7 days - please explain.
    Descrizione

    compliant when taking active drug

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1321605
    Blister pack information: Lot number
    Descrizione

    Lot number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2826710
    Blister pack information: Blister pack number
    Descrizione

    Blister pack number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C1706080
    UMLS CUI [1,2]
    C0449788
    Blister pack information: Date Dispensed
    Descrizione

    Date Dispensed

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C0011008
    Blister pack information: Number of active capsules dispensed
    Descrizione

    Number of active capsules dispensed

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0205177
    UMLS CUI [1,3]
    C0006935
    Blister pack information: Date of first dose from blister pack
    Descrizione

    Date of first dose from blister pack

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C3173309
    Blister pack information: Date blister pack returned
    Descrizione

    Date blister pack returned

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C0011008
    Blister pack information: Number of active drug capsules to be taken
    Descrizione

    Number of active drug capsules to be taken

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0006935
    Blister pack information: Actual number of active drug capsules taken
    Descrizione

    Actual number of active drug capsules taken

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0006935
    Blister pack information: Number of active capsules returned
    Descrizione

    Number of active capsules returned

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0006935
    Blister pack information: Dates of missed active doses
    Descrizione

    Dates of missed active doses

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1705492
    UMLS CUI [1,3]
    C0178602
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    Similar models

    Visit 2 Galafold (migalastat) AT1001-012 NCT01218659

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Date of visit
    C1320303 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    C0474523 (UMLS CUI-1)
    Hematology Sample Collection Date
    Item
    Hematology Sample Collection Date
    date
    C0474523 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
    integer
    C0474523 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Hematology finding; Laboratory test finding
    Code List
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Hematology: clinically significant abnormal laboratory values, please sepcify
    C0474523 (UMLS CUI-1)
    C1853129 (UMLS CUI-2)
    C2826293 (UMLS CUI-3)
    Item
    Hematology: clinically significant abnormal laboratory values, please sepcify
    integer
    C0474523 (UMLS CUI [1,1])
    C1853129 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    clinically significant abnormal laboratory values Hematology
    Code List
    Hematology: clinically significant abnormal laboratory values, please sepcify
    CL Item
    Total Hemoglobin (1)
    CL Item
    Hematocrit (2)
    CL Item
    Erythrocyte (3)
    CL Item
    Platelet Count (4)
    CL Item
    Leukocyte (5)
    CL Item
    MCV (6)
    CL Item
    MCH (7)
    CL Item
    MCHC (8)
    CL Item
    RDW (9)
    CL Item
    Neutrophils (10)
    CL Item
    Lymphocytes (11)
    CL Item
    Monocytes (12)
    CL Item
    Eosinophils (13)
    CL Item
    Basophils (14)
    CL Item
    Neutrophils, ABS (15)
    CL Item
    Lymphocytes, ABS (16)
    CL Item
    Monocytes, ABS (17)
    CL Item
    Eosinophils, ABS (18)
    CL Item
    Basophils, ABS (19)
    CL Item
    Morphology (20)
    CL Item
    Co-Ag, INR (Screening only) (21)
    CL Item
    Co-Ag, aPTT (Screening only) (22)
    Item Group
    Chemistry, Laboratory findings
    C0007996 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Chemistry Sample Collection Date
    Item
    Chemistry Sample Collection Date
    date
    C0007996 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
    integer
    C0007996 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Science of Chemistry; Laboratory test finding
    Code List
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Chemistry: clinically significant abnormal laboratory values, please specify
    C0005774 (UMLS CUI-1)
    C2826293 (UMLS CUI-2)
    Item
    Chemistry: clinically significant abnormal laboratory values, please specify
    integer
    C0005774 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    clinically significant abnormal laboratory values Chemistry
    Code List
    Chemistry: clinically significant abnormal laboratory values, please specify
    CL Item
    AST (1)
    CL Item
    ALT (2)
    CL Item
    Alkaline Phosphate (3)
    CL Item
    Total Bilirubin (4)
    CL Item
    Creatinine (5)
    CL Item
    Urea (6)
    CL Item
    Non-Fasting Glucose (7)
    CL Item
    Calcium (8)
    CL Item
    Calcium (Albumin Corrected) (9)
    CL Item
    Sodium (10)
    CL Item
    Potassium (11)
    CL Item
    Magnesium (12)
    CL Item
    Total Protein (13)
    CL Item
    Albumin (14)
    CL Item
    Bicarbonate (15)
    CL Item
    LDH (16)
    CL Item
    Blood Urea Nitrogen (BUN) (17)
    CL Item
    Chloride (18)
    CL Item
    Phosphorus (19)
    CL Item
    eGFR MDRD, ID MS Traceable (20)
    CL Item
    Cholesterol  (21)
    CL Item
    Creatinine Phosphokinase (CPK) (22)
    CL Item
    Glutamyltransferase (23)
    CL Item
    Triglyceride (24)
    CL Item
    Uric Acid (25)
    Item Group
    C0042014 (UMLS CUI-1)
    Urinalysis Sample Collection Date
    Item
    Urinalysis Sample Collection Date
    date
    C0042014 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
    integer
    C0042014 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Urinalysis; Laboratory test finding
    Code List
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Urinalysis: clinically significant abnormal laboratory values, please specify
    C0042014 (UMLS CUI-1)
    C1853129 (UMLS CUI-2)
    C2826293 (UMLS CUI-3)
    Item
    Urinalysis: clinically significant abnormal laboratory values, please specify
    integer
    C0042014 (UMLS CUI [1,1])
    C1853129 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    clinically significant abnormal laboratory values Urinalysis
    Code List
    Urinalysis: clinically significant abnormal laboratory values, please specify
    CL Item
    Specific Gravity (1)
    CL Item
    pH (2)
    CL Item
    Protein (3)
    CL Item
    Glucose (4)
    CL Item
    Ketones (5)
    CL Item
    Blood (6)
    CL Item
    Leukocyte Esterase (7)
    CL Item
    Nitrite (8)
    CL Item
    Bilirubin (9)
    CL Item
    Urobilinogen (10)
    CL Item
    WBC (11)
    CL Item
    RBC (12)
    CL Item
    Color (13)
    CL Item
    Apperance (14)
    CL Item
    Microalbumin, 24-HR Urine (mg/day) (15)
    CL Item
    Protein, 24-HR Urine (mg/day) (16)
    CL Item
    Microscopic (17)
    CL Item
    WBC Casts (18)
    CL Item
    Epithelial Cells (19)
    CL Item
    Renal Tubular Cells (20)
    CL Item
    Transitional Epithelial Cells (21)
    CL Item
    Bacterial Casts (22)
    CL Item
    Epithelial Casts (23)
    CL Item
    Fatty Casts (24)
    CL Item
    Granular Casts (25)
    CL Item
    Hyaline Casts (26)
    CL Item
    Mixed Casts (27)
    CL Item
    RBC Casts (28)
    CL Item
    Waxy Casts (29)
    CL Item
    Amorphous Urate Crystals (30)
    CL Item
    Acid Urate Crystals (31)
    CL Item
    Ammonium Biurate Crystals (32)
    CL Item
    Amorphous Crystals (33)
    CL Item
    Ammonium Oxalate Crystals (34)
    CL Item
    Ammonium Phosphate Crystals (35)
    CL Item
    Bilirubin Crystals (36)
    CL Item
    Calcium Oxalate Crystals (37)
    CL Item
    Calcium Phospate Crystals (38)
    CL Item
    Calcium Carbonate Crystals (39)
    CL Item
    Cystine Crystals (40)
    CL Item
    Cholesterol Crystals (41)
    CL Item
    Hippuric Acid Crystals (42)
    CL Item
    Leucine Crystals (43)
    CL Item
    Monosodium Urate Crystals (44)
    CL Item
    Sulfa Crystals (45)
    CL Item
    Triple Phosphate Crystals (46)
    CL Item
    Tyrosine Crystals (47)
    CL Item
    Uric Acid Crystals (48)
    CL Item
    Bacteria (49)
    CL Item
    Fat Bodies (50)
    CL Item
    Starch Granules (51)
    CL Item
    Trichomonas (52)
    CL Item
    Yeast (53)
    CL Item
    Microalbumin, Urine Conc (54)
    CL Item
    Creatinine, Urine 24-Hr (55)
    CL Item
    Creatinine, Urine Conc (56)
    CL Item
    Protein, Urine 24-Hr (57)
    CL Item
    Urine total protein, random (58)
    Item Group
    24-Hr Urine Collection
    C0455060 (UMLS CUI-1)
    24-Hr Urine Collection Start Date
    Item
    24-Hr Urine Collection Start Date
    date
    C0455060 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    24-Hr Urine Collection Start Time
    Item
    24-Hr Urine Collection Start Time
    time
    C0455060 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    24-Hr Urine Collection Stop Date
    Item
    24-Hr Urine Collection Stop Date
    date
    C0455060 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    24-Hr Urine Collection Stop Time
    Item
    24-Hr Urine Collection Stop Time
    time
    C0455060 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    24-Hr Urine Collection Total Volume
    Item
    24-Hr Urine Collection Total Volume
    float
    C0455060 (UMLS CUI [1,1])
    C2700258 (UMLS CUI [1,2])
    24-Hr Urine Collection Date Sent to Laboratory
    Item
    24-Hr Urine Collection Date Sent to Laboratory
    date
    C0455060 (UMLS CUI [1,1])
    C1515023 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    C0700325 (UMLS CUI-1)
    reference date
    Item
    Reference date
    date
    C1719096 (UMLS CUI [1])
    Visit
    Item
    Visit Type
    text
    C0545082 (UMLS CUI [1])
    eCRF
    Item
    electronic case report form
    text
    C1516308 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Assessment Date
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure measurement systolic
    integer
    C0005823 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure measurement diastolic
    integer
    C0005823 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Respiration Rate
    Item
    Respiration rate, Breathing rate (BR)
    integer
    C0231832 (UMLS CUI [1])
    Item Group
    GFR of Iohexol
    C0017654 (UMLS CUI-1)
    C0022005 (UMLS CUI-2)
    GFR of Iohexol
    Item
    GFR of Iohexol
    float
    C0017654 (UMLS CUI [1,1])
    C0022005 (UMLS CUI [1,2])
    Item Group
    C0013516 (UMLS CUI-1)
    Date echocardiography
    Item
    Date of echocardiography
    date
    C0011008 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    Item Group
    SF-36 Health Survey
    C0451287 (UMLS CUI-1)
    Item
    Was the health survey completed?
    integer
    C0451287 (UMLS CUI [1])
    Was the health survey completed?
    Code List
    Was the health survey completed?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Assessment Date
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Please rate your pain by circling the number that best describes your pain at its worst in the past 24 hours.
    integer
    C0030193 (UMLS CUI [1])
    undefined item
    Code List
    Please rate your pain by circling the number that best describes your pain at its worst in the past 24 hours.
    CL Item
    0, No pain (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10, Pain as bad a you can imagine (10)
    Item
    Please rate your pain by circling the number that best describes your pain at its least in the past 24 hours.
    integer
    C0030193 (UMLS CUI [1])
    undefined item
    Code List
    Please rate your pain by circling the number that best describes your pain at its least in the past 24 hours.
    CL Item
    0, No pain (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10, Pain as bad a you can imagine (10)
    Item
    Please rate your pain by circling the number that best describes your pain on the average
    integer
    C0030193 (UMLS CUI [1])
    undefined item
    Code List
    Please rate your pain by circling the number that best describes your pain on the average
    CL Item
    0, No pain (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10, Pain as bad a you can imagine (10)
    Item
    Please rate your pain by circling the number that best describes how much pain you have right now.
    integer
    C0030193 (UMLS CUI [1])
    undefined item
    Code List
    Please rate your pain by circling the number that best describes how much pain you have right now.
    CL Item
    0, No pain (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10, Pain as bad a you can imagine (10)
    Item Group
    C0034656 (UMLS CUI-1)
    Item
    Was the urine pregnancy test done and confirmed as negative?
    integer
    C0038454 (UMLS CUI [1])
    undefined item
    Code List
    Was the urine pregnancy test done and confirmed as negative?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    N/A (3)
    Date of Randomization
    Item
    Date of Randomization
    date
    C0034656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Randomization Number
    Item
    Randomization Number (Received via the IVRS)
    integer
    C2986235 (UMLS CUI [1])
    Item
    Treatment
    integer
    C1522541 (UMLS CUI [1])
    Treatment
    Code List
    Treatment
    CL Item
    AT1001 (1)
    CL Item
    ERT (2)
    Item Group
    C0412675 (UMLS CUI-1)
    MRI date
    Item
    MRI: Date
    date
    C0024485 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    MRI Results
    integer
    C0024485 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    MRI Results
    Code List
    MRI Results
    CL Item
    Normal (1)
    CL Item
    Abnormal, not clinically significant (2)
    CL Item
    Abnormal, clinically significant. (3)
    MRI Abnormalities
    Item
    MRI Abnormalities
    text
    C0024485 (UMLS CUI [1])
    Item
    Since the last visit, did the subject have a cardiac event that meets the secondary endpoint criteria?
    integer
    C1320716 (UMLS CUI [1])
    undefined item
    Code List
    Since the last visit, did the subject have a cardiac event that meets the secondary endpoint criteria?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
    integer
    C0038454 (UMLS CUI [1])
    undefined item
    Code List
    Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Enzyme Replacement Therapy
    C0598391 (UMLS CUI-1)
    Enzyme Replacement Therapy Infusion procedures Count
    Item
    Dosing: Record the total ERT Infusions since the last visit
    integer
    C0598391 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0750480 (UMLS CUI [1,3])
    Item
    Dosing: Were any infusions missed?
    integer
    C0598391 (UMLS CUI [1])
    Enzyme Replacement Therapy
    Code List
    Dosing: Were any infusions missed?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Enter Details of each infusion: Drug name
    integer
    C0013227 (UMLS CUI [1])
    Drug name
    Code List
    Enter Details of each infusion: Drug name
    CL Item
    Fabrazyme (1)
    CL Item
    Replagal (2)
    Date of infusion
    Item
    Enter Details of each infusion: Date of infusion
    date
    C0574032 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Prescribed Dose
    Item
    Enter Details of each infusion: Prescribed Dose
    float
    C0678766 (UMLS CUI [1])
    Item
    Enter Details of each infusion: Was the total volume infused?
    integer
    C0574032 (UMLS CUI [1,1])
    C2700258 (UMLS CUI [1,2])
    undefined item
    Code List
    Enter Details of each infusion: Was the total volume infused?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Drug log
    C0013227 (UMLS CUI-1)
    C0920316 (UMLS CUI-2)
    Date and time of dose of last active drug
    Item
    Visit Summary: Date and time of dose of last active drug
    text
    Did the subject take all required active study drug over the last 7 days
    Item
    Visit Summary: Did the subject take all required active study drug over the last 7 days?
    text
    C0205177 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0008972 (UMLS CUI [1,3])
    Number of actives capsules the subject should have taken over the last 7 days
    Item
    Visit Summary: Number of actives capsules the subject should have taken over the last 7 days
    integer
    C0205177 (UMLS CUI [1,1])
    C0006935 (UMLS CUI [1,2])
    Number of actives capsules actually taken by the subject over the last 7 days
    Item
    Visit Summary: Number of actives capsules actually taken by the subject over the last 7 days
    integer
    C0205177 (UMLS CUI [1,1])
    C0006935 (UMLS CUI [1,2])
    compliant when taking active drug
    Item
    Visit Summary: If the subject was not 100% compliant when taking active drug over the last 7 days - please explain.
    text
    C1321605 (UMLS CUI [1])
    Lot number
    Item
    Blister pack information: Lot number
    integer
    C2826710 (UMLS CUI [1])
    Blister pack number
    Item
    Blister pack information: Blister pack number
    integer
    C1706080 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Date Dispensed
    Item
    Blister pack information: Date Dispensed
    date
    C0011008 (UMLS CUI [1])
    Number of active capsules dispensed
    Item
    Blister pack information: Number of active capsules dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0205177 (UMLS CUI [1,2])
    C0006935 (UMLS CUI [1,3])
    Date of first dose from blister pack
    Item
    Blister pack information: Date of first dose from blister pack
    date
    C3173309 (UMLS CUI [1])
    Date blister pack returned
    Item
    Blister pack information: Date blister pack returned
    date
    C0011008 (UMLS CUI [1])
    Number of active drug capsules to be taken
    Item
    Blister pack information: Number of active drug capsules to be taken
    integer
    C0205177 (UMLS CUI [1,1])
    C0006935 (UMLS CUI [1,2])
    Actual number of active drug capsules taken
    Item
    Blister pack information: Actual number of active drug capsules taken
    integer
    C0205177 (UMLS CUI [1,1])
    C0006935 (UMLS CUI [1,2])
    Number of active capsules returned
    Item
    Blister pack information: Number of active capsules returned
    integer
    C0205177 (UMLS CUI [1,1])
    C0006935 (UMLS CUI [1,2])
    Dates of missed active doses
    Item
    Blister pack information: Dates of missed active doses
    date
    C0011008 (UMLS CUI [1,1])
    C1705492 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
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