0 Avaliações
ID

20112

Descrição

Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00267059

Link

https://clinicaltrials.gov/show/NCT00267059

Palavras-chave

Versões (1)
  1. 07/02/2017 07/02/2017 -
Transferido a

7 de fevereiro de 2017

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Chronic Lymphocytic Leukemia NCT00267059

    Inglês

    Eligibility Chronic Lymphocytic Leukemia NCT00267059

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients with b-cell cll with indications for treatment by national cancer institute (nci) working group criteria, or rai stage iii or iv or patients with cll requiring treatment because of any of the following: disease related symptoms, progressive marrow failure (development or worsening of anemia and/or patients' thrombocytopenia) progressive splenomegaly, progressive lymphoadenopathy, progressive lymphocytosis
    Descrição

    Chronic Lymphocytic Leukemia Requirement Therapeutic procedure | Chronic Lymphocytic Leukemia Rai Staging System | Symptoms Disease Related | Pancytopenia Progressive | Anemia Worsening | Thrombocytopenia | Splenomegaly Progressive | Lymphadenopathy Progressive | Lymphocytosis Progressive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0023434
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [2,1]
    C0023434
    UMLS CUI [2,2]
    C1514715
    UMLS CUI [3,1]
    C1457887
    UMLS CUI [3,2]
    C0012634
    UMLS CUI [3,3]
    C0439849
    UMLS CUI [4,1]
    C0030312
    UMLS CUI [4,2]
    C0205329
    UMLS CUI [5,1]
    C0002871
    UMLS CUI [5,2]
    C0332271
    UMLS CUI [6]
    C0040034
    UMLS CUI [7,1]
    C0038002
    UMLS CUI [7,2]
    C0205329
    UMLS CUI [8,1]
    C0497156
    UMLS CUI [8,2]
    C0205329
    UMLS CUI [9,1]
    C0024282
    UMLS CUI [9,2]
    C0205329
    2. patients who have received a minimum of one prior purine analog-based chemotherapy regimen. prior treatment with corticosteroids, immunotherapy, monoclonal antibody or radiation therapy is permitted. all previous cancer therapy, including radiation, hormonal therapy and surgery must have been discontinued 2 weeks prior to treatment in this study. any cytotoxic chemotherapy must be discontinued 4 weeks prior to treatment in this study.
    Descrição

    Chemotherapy Regimen Purine analog Based | Adrenal Cortex Hormones | Immunotherapy | Monoclonal Antibody Therapy | Therapeutic radiology procedure | cancer treatment Discontinued | cancer radiation therapy Discontinued | Hormone Therapy Discontinued | Operative Surgical Procedures Discontinued | Cytotoxic Chemotherapy To be stopped

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1268902
    UMLS CUI [1,3]
    C1705938
    UMLS CUI [2]
    C0001617
    UMLS CUI [3]
    C0021083
    UMLS CUI [4]
    C0279694
    UMLS CUI [5]
    C1522449
    UMLS CUI [6,1]
    C0920425
    UMLS CUI [6,2]
    C1444662
    UMLS CUI [7,1]
    C0920418
    UMLS CUI [7,2]
    C1444662
    UMLS CUI [8,1]
    C0279025
    UMLS CUI [8,2]
    C1444662
    UMLS CUI [9,1]
    C0543467
    UMLS CUI [9,2]
    C1444662
    UMLS CUI [10,1]
    C0677881
    UMLS CUI [10,2]
    C1272691
    3. age more or equal to 18 years (cll is not observed in patients less than 18 years of age).
    Descrição

    Age | Chronic Lymphocytic Leukemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0023434
    4. eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2.
    Descrição

    ECOG performance status | WHO performance status scale

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C1298650
    5. adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to 2 times the upper limit of normal.
    Descrição

    Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0201976
    UMLS CUI [3]
    C0232741
    UMLS CUI [4]
    C1278039
    6. understand and sign informed consent after the investigational nature, study design, risks and benefits of the study have been explained.
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    7. females of childbearing potential (fcbp)must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 4 weeks before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing.
    Descrição

    Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | lenalidomide | Abstinence Coitus Heterosexual | Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests Continuous

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0430061
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0430057
    UMLS CUI [3]
    C1144149
    UMLS CUI [4,1]
    C0036899
    UMLS CUI [4,2]
    C0009253
    UMLS CUI [4,3]
    C0019421
    UMLS CUI [5,1]
    C0700589
    UMLS CUI [5,2]
    C1265611
    UMLS CUI [6,1]
    C3831118
    UMLS CUI [6,2]
    C0032976
    UMLS CUI [6,3]
    C0549178
    8. continued from #7. men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
    Descrição

    Gender Male Condoms | Vasectomy | Pregnancy Precaution

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0009653
    UMLS CUI [2]
    C0042387
    UMLS CUI [3,1]
    C0032961
    UMLS CUI [3,2]
    C1882442
    9. continued from #8. a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
    Descrição

    Gender Childbearing Potential | Hysterectomy | Bilateral oophorectomy | Postmenopausal state | Menstruation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C3831118
    UMLS CUI [2]
    C0020699
    UMLS CUI [3]
    C0278321
    UMLS CUI [4]
    C0232970
    UMLS CUI [5]
    C0025344
    10. disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. patients with malignancies with indolent behavior such as prostate cancer treated with radiation can be enrolled in the study as long as they have a reasonable expectation to have been cured with treatment modality received.
    Descrição

    Malignant Neoplasms Disease Free of | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Carcinoma in situ of female breast Treated | Therapeutic radiology procedure Prostate carcinoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C0332296
    UMLS CUI [2,1]
    C0007117
    UMLS CUI [2,2]
    C1522326
    UMLS CUI [3,1]
    C0553723
    UMLS CUI [3,2]
    C1522326
    UMLS CUI [4,1]
    C0851140
    UMLS CUI [4,2]
    C1522326
    UMLS CUI [5,1]
    C0686288
    UMLS CUI [5,2]
    C1522326
    UMLS CUI [6,1]
    C1522449
    UMLS CUI [6,2]
    C0600139
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. known sensitivity to thalidomide or its derivatives
    Descrição

    Hypersensitivity Thalidomide | Hypersensitivity Thalidomide Derivative

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0039736
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0039736
    UMLS CUI [2,3]
    C1527240
    2. the development of erythema nodosum as characterized by a desquamating rash while taking thalidomide or similar drugs.
    Descrição

    Erythema Nodosum | Rash desquamating while Intake Thalidomide

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0014743
    UMLS CUI [2,1]
    C0542171
    UMLS CUI [2,2]
    C0750519
    UMLS CUI [2,3]
    C1512806
    UMLS CUI [2,4]
    C0039736
    3. prior use of lenalidomide
    Descrição

    lenalidomide

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1144149
    4. concurrent use of other chemotherapy agents.
    Descrição

    Antineoplastic Agents

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0003392
    5. known positivity for human immunodeficiency virus (hiv) or infectious hepatitis type a, b or c.
    Descrição

    HIV Seropositivity | Hepatitis A | HEPATITIS B INFECTIOUS | Hepatitis C

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    UMLS CUI [2]
    C0019159
    UMLS CUI [3]
    C0744836
    UMLS CUI [4]
    C0019196
    6. pregnant or lactating females.
    Descrição

    Pregnancy | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    7. a serious medical condition, laboratory abnormality or psychiatric illness that would pose the subject at unacceptable risk if he/she were to participate in the study or that would interfere with the ability of the patient to carry out the treatment program or confine the ability to interpret the data from the study.
    Descrição

    Medical condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental disorder Study Subject Participation Status At risk | Medical condition Protocol Compliance Limited | Laboratory test result abnormal Protocol Compliance Limited | Mental disorder Protocol Compliance Limited

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C1444641
    UMLS CUI [2,1]
    C0438215
    UMLS CUI [2,2]
    C2348568
    UMLS CUI [2,3]
    C1444641
    UMLS CUI [3,1]
    C0004936
    UMLS CUI [3,2]
    C2348568
    UMLS CUI [3,3]
    C1444641
    UMLS CUI [4,1]
    C3843040
    UMLS CUI [4,2]
    C0525058
    UMLS CUI [4,3]
    C0439801
    UMLS CUI [5,1]
    C0438215
    UMLS CUI [5,2]
    C0525058
    UMLS CUI [5,3]
    C0439801
    UMLS CUI [6,1]
    C0004936
    UMLS CUI [6,2]
    C0525058
    UMLS CUI [6,3]
    C0439801
    8. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
    Descrição

    Prolymphocytic Leukemia | Lymphocyte Count measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023486
    UMLS CUI [2]
    C0200635
    9. active cardiovascular disease as defined by the new york heart association class 3 or
    Descrição

    Cardiovascular Disease New York Heart Association Classification

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C1275491
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    Eligibility Chronic Lymphocytic Leukemia NCT00267059

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Chronic Lymphocytic Leukemia Requirement Therapeutic procedure | Chronic Lymphocytic Leukemia Rai Staging System | Symptoms Disease Related | Pancytopenia Progressive | Anemia Worsening | Thrombocytopenia | Splenomegaly Progressive | Lymphadenopathy Progressive | Lymphocytosis Progressive
    Item
    1. patients with b-cell cll with indications for treatment by national cancer institute (nci) working group criteria, or rai stage iii or iv or patients with cll requiring treatment because of any of the following: disease related symptoms, progressive marrow failure (development or worsening of anemia and/or patients' thrombocytopenia) progressive splenomegaly, progressive lymphoadenopathy, progressive lymphocytosis
    boolean
    C0023434 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C0023434 (UMLS CUI [2,1])
    C1514715 (UMLS CUI [2,2])
    C1457887 (UMLS CUI [3,1])
    C0012634 (UMLS CUI [3,2])
    C0439849 (UMLS CUI [3,3])
    C0030312 (UMLS CUI [4,1])
    C0205329 (UMLS CUI [4,2])
    C0002871 (UMLS CUI [5,1])
    C0332271 (UMLS CUI [5,2])
    C0040034 (UMLS CUI [6])
    C0038002 (UMLS CUI [7,1])
    C0205329 (UMLS CUI [7,2])
    C0497156 (UMLS CUI [8,1])
    C0205329 (UMLS CUI [8,2])
    C0024282 (UMLS CUI [9,1])
    C0205329 (UMLS CUI [9,2])
    Chemotherapy Regimen Purine analog Based | Adrenal Cortex Hormones | Immunotherapy | Monoclonal Antibody Therapy | Therapeutic radiology procedure | cancer treatment Discontinued | cancer radiation therapy Discontinued | Hormone Therapy Discontinued | Operative Surgical Procedures Discontinued | Cytotoxic Chemotherapy To be stopped
    Item
    2. patients who have received a minimum of one prior purine analog-based chemotherapy regimen. prior treatment with corticosteroids, immunotherapy, monoclonal antibody or radiation therapy is permitted. all previous cancer therapy, including radiation, hormonal therapy and surgery must have been discontinued 2 weeks prior to treatment in this study. any cytotoxic chemotherapy must be discontinued 4 weeks prior to treatment in this study.
    boolean
    C0392920 (UMLS CUI [1,1])
    C1268902 (UMLS CUI [1,2])
    C1705938 (UMLS CUI [1,3])
    C0001617 (UMLS CUI [2])
    C0021083 (UMLS CUI [3])
    C0279694 (UMLS CUI [4])
    C1522449 (UMLS CUI [5])
    C0920425 (UMLS CUI [6,1])
    C1444662 (UMLS CUI [6,2])
    C0920418 (UMLS CUI [7,1])
    C1444662 (UMLS CUI [7,2])
    C0279025 (UMLS CUI [8,1])
    C1444662 (UMLS CUI [8,2])
    C0543467 (UMLS CUI [9,1])
    C1444662 (UMLS CUI [9,2])
    C0677881 (UMLS CUI [10,1])
    C1272691 (UMLS CUI [10,2])
    Age | Chronic Lymphocytic Leukemia
    Item
    3. age more or equal to 18 years (cll is not observed in patients less than 18 years of age).
    boolean
    C0001779 (UMLS CUI [1])
    C0023434 (UMLS CUI [2])
    ECOG performance status | WHO performance status scale
    Item
    4. eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2.
    boolean
    C1520224 (UMLS CUI [1])
    C1298650 (UMLS CUI [2])
    Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement
    Item
    5. adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to 2 times the upper limit of normal.
    boolean
    C0232804 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    C0232741 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    Informed Consent
    Item
    6. understand and sign informed consent after the investigational nature, study design, risks and benefits of the study have been explained.
    boolean
    C0021430 (UMLS CUI [1])
    Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | lenalidomide | Abstinence Coitus Heterosexual | Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests Continuous
    Item
    7. females of childbearing potential (fcbp)must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 4 weeks before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0430061 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [2,1])
    C0430057 (UMLS CUI [2,2])
    C1144149 (UMLS CUI [3])
    C0036899 (UMLS CUI [4,1])
    C0009253 (UMLS CUI [4,2])
    C0019421 (UMLS CUI [4,3])
    C0700589 (UMLS CUI [5,1])
    C1265611 (UMLS CUI [5,2])
    C3831118 (UMLS CUI [6,1])
    C0032976 (UMLS CUI [6,2])
    C0549178 (UMLS CUI [6,3])
    Gender Male Condoms | Vasectomy | Pregnancy Precaution
    Item
    8. continued from #7. men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
    boolean
    C0079399 (UMLS CUI [1,1])
    C0009653 (UMLS CUI [1,2])
    C0042387 (UMLS CUI [2])
    C0032961 (UMLS CUI [3,1])
    C1882442 (UMLS CUI [3,2])
    Gender Childbearing Potential | Hysterectomy | Bilateral oophorectomy | Postmenopausal state | Menstruation
    Item
    9. continued from #8. a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
    boolean
    C0079399 (UMLS CUI [1,1])
    C3831118 (UMLS CUI [1,2])
    C0020699 (UMLS CUI [2])
    C0278321 (UMLS CUI [3])
    C0232970 (UMLS CUI [4])
    C0025344 (UMLS CUI [5])
    Malignant Neoplasms Disease Free of | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated | Carcinoma in situ of female breast Treated | Therapeutic radiology procedure Prostate carcinoma
    Item
    10. disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. patients with malignancies with indolent behavior such as prostate cancer treated with radiation can be enrolled in the study as long as they have a reasonable expectation to have been cured with treatment modality received.
    boolean
    C0006826 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0332296 (UMLS CUI [1,3])
    C0007117 (UMLS CUI [2,1])
    C1522326 (UMLS CUI [2,2])
    C0553723 (UMLS CUI [3,1])
    C1522326 (UMLS CUI [3,2])
    C0851140 (UMLS CUI [4,1])
    C1522326 (UMLS CUI [4,2])
    C0686288 (UMLS CUI [5,1])
    C1522326 (UMLS CUI [5,2])
    C1522449 (UMLS CUI [6,1])
    C0600139 (UMLS CUI [6,2])
    Item Group
    C0680251 (UMLS CUI)
    Hypersensitivity Thalidomide | Hypersensitivity Thalidomide Derivative
    Item
    1. known sensitivity to thalidomide or its derivatives
    boolean
    C0020517 (UMLS CUI [1,1])
    C0039736 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0039736 (UMLS CUI [2,2])
    C1527240 (UMLS CUI [2,3])
    Erythema Nodosum | Rash desquamating while Intake Thalidomide
    Item
    2. the development of erythema nodosum as characterized by a desquamating rash while taking thalidomide or similar drugs.
    boolean
    C0014743 (UMLS CUI [1])
    C0542171 (UMLS CUI [2,1])
    C0750519 (UMLS CUI [2,2])
    C1512806 (UMLS CUI [2,3])
    C0039736 (UMLS CUI [2,4])
    lenalidomide
    Item
    3. prior use of lenalidomide
    boolean
    C1144149 (UMLS CUI [1])
    Antineoplastic Agents
    Item
    4. concurrent use of other chemotherapy agents.
    boolean
    C0003392 (UMLS CUI [1])
    HIV Seropositivity | Hepatitis A | HEPATITIS B INFECTIOUS | Hepatitis C
    Item
    5. known positivity for human immunodeficiency virus (hiv) or infectious hepatitis type a, b or c.
    boolean
    C0019699 (UMLS CUI [1])
    C0019159 (UMLS CUI [2])
    C0744836 (UMLS CUI [3])
    C0019196 (UMLS CUI [4])
    Pregnancy | Breast Feeding
    Item
    6. pregnant or lactating females.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Medical condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental disorder Study Subject Participation Status At risk | Medical condition Protocol Compliance Limited | Laboratory test result abnormal Protocol Compliance Limited | Mental disorder Protocol Compliance Limited
    Item
    7. a serious medical condition, laboratory abnormality or psychiatric illness that would pose the subject at unacceptable risk if he/she were to participate in the study or that would interfere with the ability of the patient to carry out the treatment program or confine the ability to interpret the data from the study.
    boolean
    C3843040 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1444641 (UMLS CUI [1,3])
    C0438215 (UMLS CUI [2,1])
    C2348568 (UMLS CUI [2,2])
    C1444641 (UMLS CUI [2,3])
    C0004936 (UMLS CUI [3,1])
    C2348568 (UMLS CUI [3,2])
    C1444641 (UMLS CUI [3,3])
    C3843040 (UMLS CUI [4,1])
    C0525058 (UMLS CUI [4,2])
    C0439801 (UMLS CUI [4,3])
    C0438215 (UMLS CUI [5,1])
    C0525058 (UMLS CUI [5,2])
    C0439801 (UMLS CUI [5,3])
    C0004936 (UMLS CUI [6,1])
    C0525058 (UMLS CUI [6,2])
    C0439801 (UMLS CUI [6,3])
    Prolymphocytic Leukemia | Lymphocyte Count measurement
    Item
    8. documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
    boolean
    C0023486 (UMLS CUI [1])
    C0200635 (UMLS CUI [2])
    Cardiovascular Disease New York Heart Association Classification
    Item
    9. active cardiovascular disease as defined by the new york heart association class 3 or
    boolean
    C0007222 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
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