0 Evaluaciones
ID

41035

Descripción

Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01110031

Link

https://clinicaltrials.gov/show/NCT01110031

Palabras clave

Versiones (1)
  1. 16/6/20 16/6/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de junio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Leukaemia, Lymphocytic, Chronic NCT01110031

    Inglés

    Eligibility Leukaemia, Lymphocytic, Chronic NCT01110031

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    confirmed diagnosis of chronic lymphocytic leukemia (cll).
    Descripción

    Chronic Lymphocytic Leukemia

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    active cll disease and indication for treatment.
    Descripción

    Chronic Lymphocytic Leukemia | Indication Therapeutic procedure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    UMLS CUI [2,1]
    C3146298
    UMLS CUI [2,2]
    C0087111
    previous treatment with fludarabine-containing treatment that did not achieve at least a partial response or, disease progression occurred in responders within six months of the last dose of a fludarabine-containing treatment regimen.
    Descripción

    Prior Therapy Containing Fludarabine | Partial response failed | Therapy responder | Disease Progression

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0332256
    UMLS CUI [1,3]
    C0059985
    UMLS CUI [2,1]
    C1521726
    UMLS CUI [2,2]
    C0231175
    UMLS CUI [3]
    C0919876
    UMLS CUI [4]
    C0242656
    fully active at a minimum, or fully capable of self-care and up and about more than 50% of waking hours.
    Descripción

    Patient appears active Minimum | Cares for self

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2051409
    UMLS CUI [1,2]
    C1524031
    UMLS CUI [2]
    C3872897
    age 18 years or older.
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    signed written informed consent.
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    acceptable levels of laboratory chemistry tests of potassium and magnesium.
    Descripción

    Potassium level Acceptable | Magnesium level Acceptable

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0302353
    UMLS CUI [1,2]
    C1879533
    UMLS CUI [2,1]
    C0202125
    UMLS CUI [2,2]
    C1879533
    males and female subjects must agree to use contraception (if fertile) from the time of the first dose of study medication until one year following last dose of ofatumumab.
    Descripción

    Females & males of reproductive potential Contraceptive methods

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C4034483
    UMLS CUI [1,2]
    C0700589
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any abnormal electrocardiogram (ecg) or cardiac conduction findings .
    Descripción

    Electrocardiogram abnormal | Abnormal cardiac conduction

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0522055
    UMLS CUI [2]
    C0232219
    certain heart problems, chronic infections, or serious significant diseases.
    Descripción

    Heart problems | Chronic infectious disease | Disease Serious

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0795691
    UMLS CUI [2]
    C0151317
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C0205404
    known transformation of cll.
    Descripción

    Chronic lymphocytic leukaemia transformation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1142081
    cll central nervous sytem involvement.
    Descripción

    Central Nervous System Involvement CLL

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C4050309
    UMLS CUI [1,2]
    C0023434
    abnormal/inadequate blood values, liver, or kidney function.
    Descripción

    Hematologic function Abnormal | Liver Dysfunction | Abnormal renal function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0221130
    UMLS CUI [1,2]
    C0205161
    UMLS CUI [2]
    C0086565
    UMLS CUI [3]
    C0151746
    past or current malignancy besides cll, unless you have been free of malignancy for at least two years, have a history of completely resected non-melanoma skin cancer, or have been successfully treated.
    Descripción

    Cancer Other | Exception Free of Malignant Neoplasm | Exception Complete excision Skin carcinoma | Exception Therapeutic procedure Successful

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0332296
    UMLS CUI [2,3]
    C0006826
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0015250
    UMLS CUI [3,3]
    C0699893
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0087111
    UMLS CUI [4,3]
    C1272703
    lactating women or women with a positive pregnancy test.
    Descripción

    Breast Feeding | Pregnancy test positive

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    UMLS CUI [2]
    C0240802
    use of medications known to prolong the heart rhythm.
    Descripción

    Pharmaceutical Preparations Causing Cardiac rhythm Prolonged

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0678227
    UMLS CUI [1,3]
    C0232187
    UMLS CUI [1,4]
    C0439590
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    Similar models

    Eligibility Leukaemia, Lymphocytic, Chronic NCT01110031

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Chronic Lymphocytic Leukemia
    Item
    confirmed diagnosis of chronic lymphocytic leukemia (cll).
    boolean
    C0023434 (UMLS CUI [1])
    Chronic Lymphocytic Leukemia | Indication Therapeutic procedure
    Item
    active cll disease and indication for treatment.
    boolean
    C0023434 (UMLS CUI [1])
    C3146298 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    Prior Therapy Containing Fludarabine | Partial response failed | Therapy responder | Disease Progression
    Item
    previous treatment with fludarabine-containing treatment that did not achieve at least a partial response or, disease progression occurred in responders within six months of the last dose of a fludarabine-containing treatment regimen.
    boolean
    C1514463 (UMLS CUI [1,1])
    C0332256 (UMLS CUI [1,2])
    C0059985 (UMLS CUI [1,3])
    C1521726 (UMLS CUI [2,1])
    C0231175 (UMLS CUI [2,2])
    C0919876 (UMLS CUI [3])
    C0242656 (UMLS CUI [4])
    Patient appears active Minimum | Cares for self
    Item
    fully active at a minimum, or fully capable of self-care and up and about more than 50% of waking hours.
    boolean
    C2051409 (UMLS CUI [1,1])
    C1524031 (UMLS CUI [1,2])
    C3872897 (UMLS CUI [2])
    Age
    Item
    age 18 years or older.
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent
    Item
    signed written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Potassium level Acceptable | Magnesium level Acceptable
    Item
    acceptable levels of laboratory chemistry tests of potassium and magnesium.
    boolean
    C0302353 (UMLS CUI [1,1])
    C1879533 (UMLS CUI [1,2])
    C0202125 (UMLS CUI [2,1])
    C1879533 (UMLS CUI [2,2])
    Females & males of reproductive potential Contraceptive methods
    Item
    males and female subjects must agree to use contraception (if fertile) from the time of the first dose of study medication until one year following last dose of ofatumumab.
    boolean
    C4034483 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Electrocardiogram abnormal | Abnormal cardiac conduction
    Item
    any abnormal electrocardiogram (ecg) or cardiac conduction findings .
    boolean
    C0522055 (UMLS CUI [1])
    C0232219 (UMLS CUI [2])
    Heart problems | Chronic infectious disease | Disease Serious
    Item
    certain heart problems, chronic infections, or serious significant diseases.
    boolean
    C0795691 (UMLS CUI [1])
    C0151317 (UMLS CUI [2])
    C0012634 (UMLS CUI [3,1])
    C0205404 (UMLS CUI [3,2])
    Chronic lymphocytic leukaemia transformation
    Item
    known transformation of cll.
    boolean
    C1142081 (UMLS CUI [1])
    Central Nervous System Involvement CLL
    Item
    cll central nervous sytem involvement.
    boolean
    C4050309 (UMLS CUI [1,1])
    C0023434 (UMLS CUI [1,2])
    Hematologic function Abnormal | Liver Dysfunction | Abnormal renal function
    Item
    abnormal/inadequate blood values, liver, or kidney function.
    boolean
    C0221130 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    C0086565 (UMLS CUI [2])
    C0151746 (UMLS CUI [3])
    Cancer Other | Exception Free of Malignant Neoplasm | Exception Complete excision Skin carcinoma | Exception Therapeutic procedure Successful
    Item
    past or current malignancy besides cll, unless you have been free of malignancy for at least two years, have a history of completely resected non-melanoma skin cancer, or have been successfully treated.
    boolean
    C1707251 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0332296 (UMLS CUI [2,2])
    C0006826 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0015250 (UMLS CUI [3,2])
    C0699893 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0087111 (UMLS CUI [4,2])
    C1272703 (UMLS CUI [4,3])
    Breast Feeding | Pregnancy test positive
    Item
    lactating women or women with a positive pregnancy test.
    boolean
    C0006147 (UMLS CUI [1])
    C0240802 (UMLS CUI [2])
    Pharmaceutical Preparations Causing Cardiac rhythm Prolonged
    Item
    use of medications known to prolong the heart rhythm.
    boolean
    C0013227 (UMLS CUI [1,1])
    C0678227 (UMLS CUI [1,2])
    C0232187 (UMLS CUI [1,3])
    C0439590 (UMLS CUI [1,4])
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