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ID

36315

Description

An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02413489

Link

https://clinicaltrials.gov/show/NCT02413489

Keywords

Versions (1)
  1. 5/2/19 5/2/19 -
Copyright Holder

See clinicaltrials.gov

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May 2, 2019

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma, Mantle-Cell NCT02413489

    English

    Eligibility Lymphoma, Mantle-Cell NCT02413489

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    has diagnosis and prior treatment for each non-hodgkin's lymphoma (nhl) subtype as defined below: mantle cell lymphoma (mcl): pathologically verified diagnosis of mcl based on local pathology report, relapsed or refractory disease after at least 2 but not more than 5 prior lines of therapy, including at least one cycle of ibrutinib therapy and documented progressive disease (pd) during or after ibrutinib treatment or participants who could not tolerate ibrutinib (ie, discontinued ibrutinib due to adverse events [aes]), b) diffuse large b cell lymphoma (dlbcl): pathologically confirmed diagnosis of non-transformed dlbcl, and c) relapsed or refractory disease; participants are not eligible or considered a candidate for high-dose chemotherapy and autologous stem cell transplantation due to other organ dysfunction or comorbidities (especially pulmonary or cardiac), c) follicular lymphoma (fl): pathologically confirmed diagnosis of fl of grade 1, 2, or 3a according to world health organization (who) criteria without pathological evidence of transformation, and relapsed disease after at least two prior systemic therapies including one anti-cd20 containing combination regimen
    Description

    Non-Hodgkin Lymphoma Subtype | Mantle cell lymphoma | Mantle cell lymphoma recurrent | Mantle cell lymphoma refractory | Status post Therapeutic procedure Quantity | Ibrutinib | Progressive Disease | Intolerance to Ibrutinib | Ibrutinib Discontinued Due to Adverse event | Diffuse Large B-Cell Lymphoma | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Ineligibility High-dose chemotherapy | Ineligibility Transplantation of autologous hematopoietic stem cell | Etiology Organ dysfunction | Etiology Comorbidity | Etiology Comorbidity pulmonary | Etiology Comorbidity cardiac | Follicular Lymphoma WHO tumor classification | Transformation Absent | Recurrent Follicular Lymphoma | Status post Systemic therapy Quantity | Status post Combined Modality Therapy Containing Anti-CD20 Antibody

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024305
    UMLS CUI [1,2]
    C0449560
    UMLS CUI [2]
    C0334634
    UMLS CUI [3]
    C0677725
    UMLS CUI [4]
    C0855138
    UMLS CUI [5,1]
    C0231290
    UMLS CUI [5,2]
    C0087111
    UMLS CUI [5,3]
    C1265611
    UMLS CUI [6]
    C3501358
    UMLS CUI [7]
    C1335499
    UMLS CUI [8,1]
    C1744706
    UMLS CUI [8,2]
    C3501358
    UMLS CUI [9,1]
    C3501358
    UMLS CUI [9,2]
    C1444662
    UMLS CUI [9,3]
    C0678226
    UMLS CUI [9,4]
    C0877248
    UMLS CUI [10]
    C0079744
    UMLS CUI [11]
    C0855111
    UMLS CUI [12]
    C0855112
    UMLS CUI [13,1]
    C1512714
    UMLS CUI [13,2]
    C1328050
    UMLS CUI [14,1]
    C1512714
    UMLS CUI [14,2]
    C1831743
    UMLS CUI [15,1]
    C0015127
    UMLS CUI [15,2]
    C0349410
    UMLS CUI [16,1]
    C0015127
    UMLS CUI [16,2]
    C0009488
    UMLS CUI [17,1]
    C0015127
    UMLS CUI [17,2]
    C0009488
    UMLS CUI [17,3]
    C0024109
    UMLS CUI [18,1]
    C0015127
    UMLS CUI [18,2]
    C0009488
    UMLS CUI [18,3]
    C0018787
    UMLS CUI [19,1]
    C0024301
    UMLS CUI [19,2]
    C1301142
    UMLS CUI [20,1]
    C0040682
    UMLS CUI [20,2]
    C0332197
    UMLS CUI [21]
    C1335701
    UMLS CUI [22,1]
    C0231290
    UMLS CUI [22,2]
    C1515119
    UMLS CUI [22,3]
    C1265611
    UMLS CUI [23,1]
    C0231290
    UMLS CUI [23,2]
    C0009429
    UMLS CUI [23,3]
    C0332256
    UMLS CUI [23,4]
    C3891557
    at least 1 measurable site of disease
    Description

    Measurable Disease Site Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C1265611
    expression of cd38 by immunohistochemistry on fresh or archived tumor sample by central assessment: a) stage 1: participants whose tumors are more than or equal to (>=) 50 percent (%) positive for cd38, b) stage 2: participants whose tumors are >=1% positive for cd38
    Description

    Tumor tissue sample CD38 Gene Expression Immunohistochemistry | Tumor Cell positive for CD38 antigen Percentage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C1413221
    UMLS CUI [1,3]
    C0017262
    UMLS CUI [1,4]
    C0021044
    UMLS CUI [2,1]
    C0027651
    UMLS CUI [2,2]
    C0945928
    UMLS CUI [2,3]
    C0439165
    participant must have an ecog performance status score of 0 or 1
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. a woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to cycle 1 day 1. a man who is sexually active with a woman of childbearing potential must agree to always use condom during sexual intercourse, and all men must also not donate sperm during the study and for 4 months after receiving the last dose of study drug
    Description

    Childbearing Potential Sexual Abstinence Heterosexual | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Gender Partner in relationship Childbearing Potential | Gender Sexually active Condom use | Gender Sperm donation Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0036899
    UMLS CUI [1,3]
    C0019421
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [2,3]
    C1265611
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0430061
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0430057
    UMLS CUI [5,1]
    C0079399
    UMLS CUI [5,2]
    C0682323
    UMLS CUI [5,3]
    C3831118
    UMLS CUI [6,1]
    C0079399
    UMLS CUI [6,2]
    C0241028
    UMLS CUI [6,3]
    C0679782
    UMLS CUI [7,1]
    C0079399
    UMLS CUI [7,2]
    C0871414
    UMLS CUI [7,3]
    C0332197
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    known central nervous system lymphoma
    Description

    Central nervous system lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0742472
    prior anti-tumor therapy including (all times measured prior to start of study drug): nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 2 weeks, investigational agents within 3 weeks, unless antibody this should be within 4 weeks
    Description

    Cancer treatment | Nitrosoureas | Chemotherapy | Antibody therapy | Radioimmunoconjugates | Toxin Immunoconjugates | Therapeutic radiology procedure | Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    UMLS CUI [2]
    C0028210
    UMLS CUI [3]
    C0392920
    UMLS CUI [4]
    C0281176
    UMLS CUI [5]
    C0243019
    UMLS CUI [6,1]
    C0040549
    UMLS CUI [6,2]
    C0243020
    UMLS CUI [7]
    C1522449
    UMLS CUI [8]
    C0013230
    daratumumab or other anti-cd38 therapies
    Description

    daratumumab | Therapy Against CD38

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2346801
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0521124
    UMLS CUI [2,3]
    C0075742
    participant has a history of malignancy (other than nhl) within 5 years before the screening period (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary non-invasive tumors), or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
    Description

    Malignant Neoplasms | Exception Non-Hodgkin Lymphoma | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Invasive carcinoma of urinary bladder | Exception Papillary neoplasm of low malignant potential | Exception Primary tumor Non-invasive | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0024305
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0553723
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0007117
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0851140
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C1827293
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C0476073
    UMLS CUI [7,3]
    C0154129
    UMLS CUI [8,1]
    C1705847
    UMLS CUI [8,2]
    C0677930
    UMLS CUI [8,3]
    C0205303
    UMLS CUI [9,1]
    C1705847
    UMLS CUI [9,2]
    C0006826
    UMLS CUI [9,3]
    C1880198
    UMLS CUI [10,1]
    C1705847
    UMLS CUI [10,2]
    C4528387
    UMLS CUI [10,3]
    C0034897
    participant has known chronic obstructive pulmonary disease (copd) with a forced expiratory volume in 1 second (fev1) less than (<) 50% predicted normal. note that fev1 testing is required for patients suspected of having copd and participants must be excluded if fev1 <50% b) participant has known moderate or severe persistent asthma within 2 years (see attachment 4: nhlbi table of asthma severity), or currently has uncontrolled asthma of any classification. (note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
    Description

    Chronic Obstructive Airway Disease | Percent predicted FEV1 | Moderate persistent asthma | Severe persistent asthma | Asthma Uncontrolled | Intermittent asthma Controlled allowed | Mild persistent asthma Controlled allowed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024117
    UMLS CUI [2]
    C0730561
    UMLS CUI [3]
    C1960047
    UMLS CUI [4]
    C1960048
    UMLS CUI [5,1]
    C0004096
    UMLS CUI [5,2]
    C0205318
    UMLS CUI [6,1]
    C1740754
    UMLS CUI [6,2]
    C2911690
    UMLS CUI [6,3]
    C0683607
    UMLS CUI [7,1]
    C1960046
    UMLS CUI [7,2]
    C2911690
    UMLS CUI [7,3]
    C0683607
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    Similar models

    Eligibility Lymphoma, Mantle-Cell NCT02413489

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-Hodgkin Lymphoma Subtype | Mantle cell lymphoma | Mantle cell lymphoma recurrent | Mantle cell lymphoma refractory | Status post Therapeutic procedure Quantity | Ibrutinib | Progressive Disease | Intolerance to Ibrutinib | Ibrutinib Discontinued Due to Adverse event | Diffuse Large B-Cell Lymphoma | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Ineligibility High-dose chemotherapy | Ineligibility Transplantation of autologous hematopoietic stem cell | Etiology Organ dysfunction | Etiology Comorbidity | Etiology Comorbidity pulmonary | Etiology Comorbidity cardiac | Follicular Lymphoma WHO tumor classification | Transformation Absent | Recurrent Follicular Lymphoma | Status post Systemic therapy Quantity | Status post Combined Modality Therapy Containing Anti-CD20 Antibody
    Item
    has diagnosis and prior treatment for each non-hodgkin's lymphoma (nhl) subtype as defined below: mantle cell lymphoma (mcl): pathologically verified diagnosis of mcl based on local pathology report, relapsed or refractory disease after at least 2 but not more than 5 prior lines of therapy, including at least one cycle of ibrutinib therapy and documented progressive disease (pd) during or after ibrutinib treatment or participants who could not tolerate ibrutinib (ie, discontinued ibrutinib due to adverse events [aes]), b) diffuse large b cell lymphoma (dlbcl): pathologically confirmed diagnosis of non-transformed dlbcl, and c) relapsed or refractory disease; participants are not eligible or considered a candidate for high-dose chemotherapy and autologous stem cell transplantation due to other organ dysfunction or comorbidities (especially pulmonary or cardiac), c) follicular lymphoma (fl): pathologically confirmed diagnosis of fl of grade 1, 2, or 3a according to world health organization (who) criteria without pathological evidence of transformation, and relapsed disease after at least two prior systemic therapies including one anti-cd20 containing combination regimen
    boolean
    C0024305 (UMLS CUI [1,1])
    C0449560 (UMLS CUI [1,2])
    C0334634 (UMLS CUI [2])
    C0677725 (UMLS CUI [3])
    C0855138 (UMLS CUI [4])
    C0231290 (UMLS CUI [5,1])
    C0087111 (UMLS CUI [5,2])
    C1265611 (UMLS CUI [5,3])
    C3501358 (UMLS CUI [6])
    C1335499 (UMLS CUI [7])
    C1744706 (UMLS CUI [8,1])
    C3501358 (UMLS CUI [8,2])
    C3501358 (UMLS CUI [9,1])
    C1444662 (UMLS CUI [9,2])
    C0678226 (UMLS CUI [9,3])
    C0877248 (UMLS CUI [9,4])
    C0079744 (UMLS CUI [10])
    C0855111 (UMLS CUI [11])
    C0855112 (UMLS CUI [12])
    C1512714 (UMLS CUI [13,1])
    C1328050 (UMLS CUI [13,2])
    C1512714 (UMLS CUI [14,1])
    C1831743 (UMLS CUI [14,2])
    C0015127 (UMLS CUI [15,1])
    C0349410 (UMLS CUI [15,2])
    C0015127 (UMLS CUI [16,1])
    C0009488 (UMLS CUI [16,2])
    C0015127 (UMLS CUI [17,1])
    C0009488 (UMLS CUI [17,2])
    C0024109 (UMLS CUI [17,3])
    C0015127 (UMLS CUI [18,1])
    C0009488 (UMLS CUI [18,2])
    C0018787 (UMLS CUI [18,3])
    C0024301 (UMLS CUI [19,1])
    C1301142 (UMLS CUI [19,2])
    C0040682 (UMLS CUI [20,1])
    C0332197 (UMLS CUI [20,2])
    C1335701 (UMLS CUI [21])
    C0231290 (UMLS CUI [22,1])
    C1515119 (UMLS CUI [22,2])
    C1265611 (UMLS CUI [22,3])
    C0231290 (UMLS CUI [23,1])
    C0009429 (UMLS CUI [23,2])
    C0332256 (UMLS CUI [23,3])
    C3891557 (UMLS CUI [23,4])
    Measurable Disease Site Quantity
    Item
    at least 1 measurable site of disease
    boolean
    C1513041 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    Tumor tissue sample CD38 Gene Expression Immunohistochemistry | Tumor Cell positive for CD38 antigen Percentage
    Item
    expression of cd38 by immunohistochemistry on fresh or archived tumor sample by central assessment: a) stage 1: participants whose tumors are more than or equal to (>=) 50 percent (%) positive for cd38, b) stage 2: participants whose tumors are >=1% positive for cd38
    boolean
    C0475358 (UMLS CUI [1,1])
    C1413221 (UMLS CUI [1,2])
    C0017262 (UMLS CUI [1,3])
    C0021044 (UMLS CUI [1,4])
    C0027651 (UMLS CUI [2,1])
    C0945928 (UMLS CUI [2,2])
    C0439165 (UMLS CUI [2,3])
    ECOG performance status
    Item
    participant must have an ecog performance status score of 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    Childbearing Potential Sexual Abstinence Heterosexual | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Gender Partner in relationship Childbearing Potential | Gender Sexually active Condom use | Gender Sperm donation Absent
    Item
    women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. a woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to cycle 1 day 1. a man who is sexually active with a woman of childbearing potential must agree to always use condom during sexual intercourse, and all men must also not donate sperm during the study and for 4 months after receiving the last dose of study drug
    boolean
    C3831118 (UMLS CUI [1,1])
    C0036899 (UMLS CUI [1,2])
    C0019421 (UMLS CUI [1,3])
    C3831118 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    C3831118 (UMLS CUI [3,1])
    C0430061 (UMLS CUI [3,2])
    C3831118 (UMLS CUI [4,1])
    C0430057 (UMLS CUI [4,2])
    C0079399 (UMLS CUI [5,1])
    C0682323 (UMLS CUI [5,2])
    C3831118 (UMLS CUI [5,3])
    C0079399 (UMLS CUI [6,1])
    C0241028 (UMLS CUI [6,2])
    C0679782 (UMLS CUI [6,3])
    C0079399 (UMLS CUI [7,1])
    C0871414 (UMLS CUI [7,2])
    C0332197 (UMLS CUI [7,3])
    Item Group
    C0680251 (UMLS CUI)
    Central nervous system lymphoma
    Item
    known central nervous system lymphoma
    boolean
    C0742472 (UMLS CUI [1])
    Cancer treatment | Nitrosoureas | Chemotherapy | Antibody therapy | Radioimmunoconjugates | Toxin Immunoconjugates | Therapeutic radiology procedure | Investigational New Drugs
    Item
    prior anti-tumor therapy including (all times measured prior to start of study drug): nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 2 weeks, investigational agents within 3 weeks, unless antibody this should be within 4 weeks
    boolean
    C0920425 (UMLS CUI [1])
    C0028210 (UMLS CUI [2])
    C0392920 (UMLS CUI [3])
    C0281176 (UMLS CUI [4])
    C0243019 (UMLS CUI [5])
    C0040549 (UMLS CUI [6,1])
    C0243020 (UMLS CUI [6,2])
    C1522449 (UMLS CUI [7])
    C0013230 (UMLS CUI [8])
    daratumumab | Therapy Against CD38
    Item
    daratumumab or other anti-cd38 therapies
    boolean
    C2346801 (UMLS CUI [1])
    C0087111 (UMLS CUI [2,1])
    C0521124 (UMLS CUI [2,2])
    C0075742 (UMLS CUI [2,3])
    Malignant Neoplasms | Exception Non-Hodgkin Lymphoma | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Invasive carcinoma of urinary bladder | Exception Papillary neoplasm of low malignant potential | Exception Primary tumor Non-invasive | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence
    Item
    participant has a history of malignancy (other than nhl) within 5 years before the screening period (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary non-invasive tumors), or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0024305 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0553723 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0007117 (UMLS CUI [4,2])
    C1705847 (UMLS CUI [5,1])
    C0851140 (UMLS CUI [5,2])
    C1705847 (UMLS CUI [6,1])
    C1827293 (UMLS CUI [6,2])
    C1705847 (UMLS CUI [7,1])
    C0476073 (UMLS CUI [7,2])
    C0154129 (UMLS CUI [7,3])
    C1705847 (UMLS CUI [8,1])
    C0677930 (UMLS CUI [8,2])
    C0205303 (UMLS CUI [8,3])
    C1705847 (UMLS CUI [9,1])
    C0006826 (UMLS CUI [9,2])
    C1880198 (UMLS CUI [9,3])
    C1705847 (UMLS CUI [10,1])
    C4528387 (UMLS CUI [10,2])
    C0034897 (UMLS CUI [10,3])
    Chronic Obstructive Airway Disease | Percent predicted FEV1 | Moderate persistent asthma | Severe persistent asthma | Asthma Uncontrolled | Intermittent asthma Controlled allowed | Mild persistent asthma Controlled allowed
    Item
    participant has known chronic obstructive pulmonary disease (copd) with a forced expiratory volume in 1 second (fev1) less than (<) 50% predicted normal. note that fev1 testing is required for patients suspected of having copd and participants must be excluded if fev1 <50% b) participant has known moderate or severe persistent asthma within 2 years (see attachment 4: nhlbi table of asthma severity), or currently has uncontrolled asthma of any classification. (note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
    boolean
    C0024117 (UMLS CUI [1])
    C0730561 (UMLS CUI [2])
    C1960047 (UMLS CUI [3])
    C1960048 (UMLS CUI [4])
    C0004096 (UMLS CUI [5,1])
    C0205318 (UMLS CUI [5,2])
    C1740754 (UMLS CUI [6,1])
    C2911690 (UMLS CUI [6,2])
    C0683607 (UMLS CUI [6,3])
    C1960046 (UMLS CUI [7,1])
    C2911690 (UMLS CUI [7,2])
    C0683607 (UMLS CUI [7,3])
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