0 Avaliações

ID

18589

Descrição

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

Palavras-chave

  1. 02/11/2016 02/11/2016 -
  2. 11/11/2016 11/11/2016 -
Transferido a

11 de novembro de 2016

DOI

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Licença

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
    Descrição

    Date of visit

    Alias
    UMLS CUI-1
    C1320303
    Date of visit
    Descrição

    Date of visit

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    12 Lead ECG
    Descrição

    12 Lead ECG

    Alias
    UMLS CUI-1
    C1623258
    Date ECG was performed
    Descrição

    ECG Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0011008
    ECG results
    Descrição

    ECG results

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1623258
    Hematology/Coagulation
    Descrição

    Hematology/Coagulation

    Alias
    UMLS CUI-1
    C0474523
    Hematology Sample Collection Date
    Descrição

    Hematology Sample Collection Date

    Tipo de dados

    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?
    Descrição

    Hematology finding; Laboratory test finding

    Tipo de dados

    integer

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

    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
    Descrição

    If lab abnormalities=Yes

    Tipo de dados

    integer

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

    Chemistry, Laboratory findings

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

    Chemistry Sample Collection Date

    Tipo de dados

    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?
    Descrição

    Science of Chemistry; Laboratory test finding

    Tipo de dados

    integer

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

    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
    Descrição

    If lab abnormalities=Yes

    Tipo de dados

    integer

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

    Urinanalysis

    Alias
    UMLS CUI-1
    C0042014
    Urinalysis Sample Collection Date
    Descrição

    Urinalysis Sample Collection Date

    Tipo de dados

    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?
    Descrição

    Urinalysis; Laboratory test finding

    Tipo de dados

    integer

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

    Urinalysis: clinically significant abnormal laboratory values

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C1853129
    UMLS CUI-3
    C2826293
    Urinalysis: clinically significant abnormal laboratory values
    Descrição

    If lab abnormalities=Yes

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C1853129
    UMLS CUI [1,3]
    C2826293
    Additional Observations
    Descrição

    Additional Observations

    Alias
    UMLS CUI-1
    C0700325
    Reference date
    Descrição

    reference date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1719096
    Visit Type
    Descrição

    Visit

    Tipo de dados

    text

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

    eCRF

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1516308
    Comment
    Descrição

    Comment

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0947611
    Vital Signs
    Descrição

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date of Assessment
    Descrição

    Assessment Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2985720
    Body weight
    Descrição

    Weight

    Tipo de dados

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Blood pressure measurement
    Descrição

    Blood pressure

    Tipo de dados

    text

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Blood pressure measurement diastolic
    Descrição

    Blood pressure

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Heart rate
    Descrição

    Heart rate

    Tipo de dados

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Respiration rate, Breathing rate (BR)
    Descrição

    Respiration Rate

    Tipo de dados

    integer

    Unidades de medida
    • /min
    Alias
    UMLS CUI [1]
    C0231832
    /min
    Secondary Endpoint Criteria
    Descrição

    Secondary Endpoint Criteria

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

    cardiovascular event

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1320716
    Was the subject sent for a cardiac consult?
    Descrição

    cardiac consult

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0009818
    UMLS CUI [1,2]
    C0007226
    Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
    Descrição

    cerebrovascular event

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0038454
    Was the subject sent for a neurological consult?
    Descrição

    neurological consult

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0849229
    Physical Examination
    Descrição

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Date Physical Examination performed:
    Descrição

    Date of Examination

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2826643
    Physical Exam Status
    Descrição

    Physical Exam Status

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Physical Exam Findings, Body Systems
    Descrição

    If Clinically significant findings, please specify

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Physical Exam Findings
    Descrição

    If Clinically significant findings, please specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0031809

    Similar models

    Follow-up Galafold (migalastat) AT1001-012 NCT01218659

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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
    Musculoskeletal (9)
    CL Item
    General (10)
    Physical Exam Findings
    Item
    Physical Exam Findings
    text
    C0031809 (UMLS CUI [1])

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