0 Ratings

ID

18589

Description

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 Follow-up

Keywords

  1. 11/2/16 11/2/16 -
  2. 11/11/16 11/11/16 -
Uploaded on

November 11, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    Follow-up Galafold (migalastat) AT1001-012 NCT01218659

    Follow-up Galafold (migalastat) AT1001-012 NCT01218659

    Date of visit
    Description

    Date of visit

    Alias
    UMLS CUI-1
    C1320303 (Date of visit)
    SNOMED
    406543005
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    12 Lead ECG
    Description

    12 Lead ECG

    Alias
    UMLS CUI-1
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    Date ECG was performed
    Description

    ECG Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    ECG results
    Description

    ECG results

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    Hematology/Coagulation
    Description

    Hematology/Coagulation

    Alias
    UMLS CUI-1
    C0474523 (Hematology finding)
    SNOMED
    250207003
    Hematology Sample Collection Date
    Description

    Hematology Sample Collection Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
    Description

    Hematology finding; Laboratory test finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    UMLS CUI [1,2]
    C0587081 (Laboratory test finding)
    SNOMED
    118246004
    Hematology: clinically significant abnormal laboratory values, please sepcify
    Description

    Hematology: clinically significant abnormal laboratory values, please sepcify

    Alias
    UMLS CUI-1
    C0474523 (Hematology finding)
    SNOMED
    250207003
    UMLS CUI-2
    C1853129 (LABORATORY ABNORMALITIES)
    UMLS CUI-3
    C2826293 (Clinical Significance)
    Hematology: clinically significant abnormal laboratory values, please sepcify
    Description

    If lab abnormalities=Yes

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    UMLS CUI [1,2]
    C1853129 (LABORATORY ABNORMALITIES)
    UMLS CUI [1,3]
    C2826293 (Clinical Significance)
    Chemistry, Laboratory findings
    Description

    Chemistry, Laboratory findings

    Alias
    UMLS CUI-1
    C0007996 (Science of Chemistry)
    UMLS CUI-2
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Chemistry Sample Collection Date
    Description

    Chemistry Sample Collection Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0007996 (Science of Chemistry)
    UMLS CUI [1,2]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
    Description

    Science of Chemistry; Laboratory test finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0007996 (Science of Chemistry)
    UMLS CUI [1,2]
    C0587081 (Laboratory test finding)
    SNOMED
    118246004
    Chemistry: clinically significant abnormal laboratory values, please specify
    Description

    Chemistry: clinically significant abnormal laboratory values, please specify

    Alias
    UMLS CUI-1
    C0005774 (Blood Chemical Analysis)
    SNOMED
    166312007
    UMLS CUI-2
    C2826293 (Clinical Significance)
    Chemistry: clinically significant abnormal laboratory values, please specify
    Description

    If lab abnormalities=Yes

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005774 (Blood Chemical Analysis)
    SNOMED
    166312007
    UMLS CUI [1,2]
    C2826293 (Clinical Significance)
    Urinanalysis
    Description

    Urinanalysis

    Alias
    UMLS CUI-1
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    Urinalysis Sample Collection Date
    Description

    Urinalysis Sample Collection Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    UMLS CUI [1,2]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
    Description

    Urinalysis; Laboratory test finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    UMLS CUI [1,2]
    C0587081 (Laboratory test finding)
    SNOMED
    118246004
    Urinalysis: clinically significant abnormal laboratory values
    Description

    Urinalysis: clinically significant abnormal laboratory values

    Alias
    UMLS CUI-1
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    UMLS CUI-2
    C1853129 (LABORATORY ABNORMALITIES)
    UMLS CUI-3
    C2826293 (Clinical Significance)
    Urinalysis: clinically significant abnormal laboratory values
    Description

    If lab abnormalities=Yes

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    UMLS CUI [1,2]
    C1853129 (LABORATORY ABNORMALITIES)
    UMLS CUI [1,3]
    C2826293 (Clinical Significance)
    Additional Observations
    Description

    Additional Observations

    Alias
    UMLS CUI-1
    C0700325 (Patient observation)
    SNOMED
    103705002
    Reference date
    Description

    reference date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1719096 (Assessment reference date)
    LOINC
    MTHU029615
    Visit Type
    Description

    Visit

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    electronic case report form
    Description

    eCRF

    Data type

    text

    Alias
    UMLS CUI [1]
    C1516308 (Case Report Form)
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Date of Assessment
    Description

    Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Body weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Blood pressure measurement
    Description

    Blood pressure

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    mmHg
    Blood pressure measurement diastolic
    Description

    Blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    bpm
    Respiration rate, Breathing rate (BR)
    Description

    Respiration Rate

    Data type

    integer

    Measurement units
    • /min
    Alias
    UMLS CUI [1]
    C0231832 (Respiratory rate)
    SNOMED
    86290005
    LOINC
    LP20159-7
    /min
    Secondary Endpoint Criteria
    Description

    Secondary Endpoint Criteria

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

    cardiovascular event

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1320716 (Cardiovascular event)
    SNOMED
    405617006
    Was the subject sent for a cardiac consult?
    Description

    cardiac consult

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0009818 (Consultation)
    SNOMED
    11429006
    LOINC
    LA7553-6
    UMLS CUI [1,2]
    C0007226 (Cardiovascular system)
    SNOMED
    113257007
    LOINC
    LP7118-5
    Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
    Description

    cerebrovascular event

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0038454 (Cerebrovascular accident)
    SNOMED
    230690007
    LOINC
    MTHU020801
    Was the subject sent for a neurological consult?
    Description

    neurological consult

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0849229 (consult with specialist for neurological system)
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Date Physical Examination performed:
    Description

    Date of Examination

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643 (Physical Examination Date)
    Physical Exam Status
    Description

    Physical Exam Status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Physical Exam Findings, Body Systems
    Description

    If Clinically significant findings, please specify

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Physical Exam Findings
    Description

    If Clinically significant findings, please specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014

    Similar models

    Follow-up Galafold (migalastat) AT1001-012 NCT01218659

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of visit
    C1320303 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    12 Lead ECG
    C1623258 (UMLS CUI-1)
    ECG Date
    Item
    Date ECG was performed
    date
    C0013798 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    ECG results
    integer
    C1623258 (UMLS CUI [1])
    Code List
    ECG results
    CL Item
    Normal (1)
    CL Item
    Abnormal, not clinically significant (2)
    CL Item
    Abnormal, clinically significant (3)
    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])
    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])
    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])
    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])
    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])
    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
    C0042014 (UMLS CUI-1)
    C1853129 (UMLS CUI-2)
    C2826293 (UMLS CUI-3)
    Item
    Urinalysis: clinically significant abnormal laboratory values
    integer
    C0042014 (UMLS CUI [1,1])
    C1853129 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Code List
    Urinalysis: clinically significant abnormal laboratory values
    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
    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
    text
    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
    Since the last visit, did the subject have a cardiac event that meets the secondary endpoint criteria?
    integer
    C1320716 (UMLS CUI [1])
    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
    Was the subject sent for a cardiac consult?
    integer
    C0009818 (UMLS CUI [1,1])
    C0007226 (UMLS CUI [1,2])
    Code List
    Was the subject sent for a cardiac consult?
    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])
    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
    Was the subject sent for a neurological consult?
    integer
    C0849229 (UMLS CUI [1])
    Code List
    Was the subject sent for a neurological consult?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Date of Examination
    Item
    Date Physical Examination performed:
    date
    C2826643 (UMLS CUI [1])
    Item
    Physical Exam Status
    integer
    C0031809 (UMLS CUI [1])
    Code List
    Physical Exam Status
    CL Item
    No clinically significant findings since previous Physical Examination (1)
    CL Item
    Clinically significant findings (2)
    CL Item
    Not done (3)
    Item
    Physical Exam Findings, Body Systems
    integer
    C0031809 (UMLS CUI [1])
    Code List
    Physical Exam Findings, Body Systems
    CL Item
    Head/Eyes/Ears/Nose/Throat (1)
    CL Item
    Respiratory (2)
    CL Item
    Cardiovascular (3)
    CL Item
    Dermatological (4)
    CL Item
    Lymphatics/Lymph nodes (5)
    CL Item
    Gastrointestinal (6)
    CL Item
    Neurological (7)
    CL Item
    Genitourinary (8)
    CL Item
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    Physical Exam Findings
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    Physical Exam Findings
    text
    C0031809 (UMLS CUI [1])

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