ID

30221

Descripción

https://clinicaltrials.gov/show/NCT00989664 Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Link

https://clinicaltrials.gov/show/NCT00989664

Palabras clave

Versiones (2)
  1. 30/4/18 30/4/18 -
  2. 22/5/18 22/5/18 -
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

22 de mayo de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

    Inglés

    Patient Enrollment, Demographics and Eligibility check

    1 formularios  
    Administration
    Descripción

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Site Number:
    Descripción

    Site Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0018704
    UMLS CUI [1,2]
    C0600091
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Descripción

    Patient Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    Demographics
    Descripción

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    Patient body weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Patient height
    Descripción

    Height

    Tipo de datos

    integer

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Patient date of birth
    Descripción

    Date of birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Descripción

    Gender

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Does the patient have a histologically confirmed initial diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to International Working Formulation [i.e., small lymphocytic (with or without plasmacytoid differentiation); follicular, small-cleaved; or follicular, mixed small-cleaved lymphoma], low-grade lymphoma that has transformed to higher grade histology, or de novo follicular, large cell lymphoma?
    Descripción

    Non-Hodgkins B-cell lymphoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0024305
    Date of original diagnosis
    Descripción

    Date of diagnosis

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2316983
    IWF lymphoma histology at initial diagnosis
    Descripción

    IWF lymphoma histology

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0024299
    Has transformation occurred?
    Descripción

    Transformation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1510411
    If Yes:
    Descripción

    Transformation

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1510411
    Date of transformation
    Descripción

    Date of transformation

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1510411
    Sites of disease at protocol entry:
    Descripción

    Sites of disease

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0027653
    Does the patient have evidence that they tumor tissue expresses the CD20 antigen? Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity with Anti-B1-Antibody (Coulter Clone) or similar commercially-available CD20 antibody (greater than 50% of tumor cells are positive) are acceptable evidence of CD20 positivity.
    Descripción

    CD20 Positivity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0054946
    UMLS CUI [1,2]
    C0024299
    Was the patient treated with at least 4 doses of rituximab at any time and failed to achieve an objective response (CR, CCR, PR), or relapsed/progressed during treatment or following the completion of rituximab therapy?
    Descripción

    Rituximab therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0393022
    Number of rituximab therapy doses received
    Descripción

    Number of rituximab doses

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0750480
    UMLS CUI [1,3]
    C0393022
    Effect of rituximab therapy
    Descripción

    Effect of rituximab therapy

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0393022
    Does the patient have a performance status of at least 60 on the Karnofsky Scale and an anticipated survival of at least three months?
    Descripción

    Karnofsky Scale and life expectancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0206065
    UMLS CUI [1,2]
    C0023671
    Does the patient have an absolute granulocyte count >1,500 cells/mm³ and a platelet count >100,000 cells/mm³ within 14 days of study entry? These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
    Descripción

    Granulocyte and platelet count

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0857490
    UMLS CUI [1,2]
    C0005821
    Date
    Descripción

    Date of blood sample

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0011008
    ANC
    Descripción

    ANC

    Tipo de datos

    integer

    Unidades de medida
    • mm³
    Alias
    UMLS CUI [1]
    C0948762
    mm³
    Platelet count
    Descripción

    Platelet count

    Tipo de datos

    integer

    Unidades de medida
    • mm^3
    Alias
    UMLS CUI [1]
    C0005821
    mm^3
    Does the patient have adequate renal function (defined as serum creatinine <1,5 x upper limit of normal) and hepatic function [defined ad total bilirubin <1,5 x upper limit of normal and transaminase (AST and ALT) <5 x upper limit of normal] within 14 days of study entry?
    Descripción

    Renal and hepatic function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0232804
    UMLS CUI [1,2]
    C0232741
    Date
    Descripción

    Date of laboratory tests

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0022885
    Creatinine
    Descripción

    Creatinine

    Tipo de datos

    float

    Unidades de medida
    • mg/dL; ULN
    Alias
    UMLS CUI [1]
    C0201976
    mg/dL; ULN
    Bilirubin
    Descripción

    Bilirubin

    Tipo de datos

    float

    Unidades de medida
    • mg/dL; ULN
    Alias
    UMLS CUI [1]
    C1278039
    mg/dL; ULN
    AST
    Descripción

    AST

    Tipo de datos

    float

    Unidades de medida
    • IU/L; ULN
    Alias
    UMLS CUI [1]
    C0201899
    IU/L; ULN
    ALT
    Descripción

    ALT

    Tipo de datos

    float

    Unidades de medida
    • IU/L; ULN
    Alias
    UMLS CUI [1]
    C0201836
    IU/L; ULN
    Does the patient have bi-dimensional measurable disease? At least one lesion must be ≥ 2x2 cm.
    Descripción

    Bi-dimensional measurable disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1705052
    Is the patient at least 18 years of age?
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Has the patient signed the IRB-approved written informed consent form prior to study entry?
    Descripción

    Informed consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Date consent signed
    Descripción

    Date of informed consent

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985782
    Exclusion criteria
    Descripción

    Exclusion criteria

    Alias
    UMLS CUI-1
    C0680251
    Does the patient have an average of >25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically at study entry? Verification of bone marrow status is required within 42 days of initial study entry. Bilateral posterior iliac crest core biopsies are required if the percentage of intratrabecular space involved exceeds 10% on a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.
    Descripción

    Bone marrow involved in Lymphoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1517677
    UMLS CUI [2]
    C0005954
    Has the patient received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (six weeks for nitrosourea compounds) or continued to exhibit clinical evidence of toxicity? The use of glucocorticoids must be discontinued (except maintenance dose steroids) at least 1 week prior to study entry.
    Descripción

    Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1522449
    UMLS CUI [3]
    C0021081
    UMLS CUI [4]
    C0199974
    Has the patient undergone prior hematopoietic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy?
    Descripción

    Stem cell transplant and chemo/radiotherapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3874407
    UMLS CUI [1,2]
    C0279134
    Does the patient have active obstructive hydronephrosis?
    Descripción

    Obstructive hydronephrosis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020295
    UMLS CUI [1,2]
    C0549186
    Does the patient have evidence of active infection requiring intravenous antibiotics at the time of study entry?
    Descripción

    Active infection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205177
    Does the patient have New York Heart Association class III or IV heart disease or another serious illness that would preclude evaluation?
    Descripción

    NYHA heart disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C1275491
    Has the patient had prior malignancy other than lymphoma, except for adequately-treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 Years?
    Descripción

    Cancer history

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0006826
    Does the patient have known HIV infection?
    Descripción

    HIV infection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    Does the patient have known brain or leptomeningeal metastases?
    Descripción

    Brain or leptomeningeal metastases

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0220650
    UMLS CUI [1,2]
    C1704231
    Is the patient pregnant or nursing? Patient of childbearing potential mist have a negative pregnancy test result within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained.
    Descripción

    Pregnancy or nursing

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    Has the patient had previous allergic reactions to iodine (with the exception of reactions to intravenous iodine-containing contrast materials)?
    Descripción

    Allergic reactions to iodine

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0021968
    Has the patient previously received radioimmunotherapy?
    Descripción

    Radioimmunotherapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0085101
    Has the patient had progressive disease within one year of irradiation arising in a field that has been previously irradiated with >3500 cGy?
    Descripción

    Progressive disease in field of irradiation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1335499
    UMLS CUI [1,2]
    C2169147
    Is the patient HAMA-positive?
    Descripción

    HAMA positivity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3541258
    Is the patient receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
    Descripción

    Anti-cancer drugs or biologics

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    Administration
    Descripción

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Investigator signature
    Descripción

    Signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Descripción

    Signature date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Patient Enrollment Authorized by
    Descripción

    Patient Enrollment Authorized

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1555472
    UMLS CUI [1,2]
    C2700391
    UMLS CUI [1,3]
    C4041024
    Date
    Descripción

    Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0680281
    Approved dose
    Descripción

    Approved dose

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0205540
    Adjust mCi dose for obesity
    Descripción

    Adjust mCi dose

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1707811
    Volver a la parte superior de la página

    Similar models

    Patient Enrollment, Demographics and Eligibility check

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Site Number
    Item
    Site Number:
    integer
    C0018704 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Demographics
    C0011298 (UMLS CUI-1)
    Weight
    Item
    Patient body weight
    float
    C0005910 (UMLS CUI [1])
    Height
    Item
    Patient height
    integer
    C0005890 (UMLS CUI [1])
    Date of birth
    Item
    Patient date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    M (1)
    CL Item
    F (2)
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Non-Hodgkins B-cell lymphoma
    Item
    Does the patient have a histologically confirmed initial diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to International Working Formulation [i.e., small lymphocytic (with or without plasmacytoid differentiation); follicular, small-cleaved; or follicular, mixed small-cleaved lymphoma], low-grade lymphoma that has transformed to higher grade histology, or de novo follicular, large cell lymphoma?
    boolean
    C0024305 (UMLS CUI [1])
    Date of diagnosis
    Item
    Date of original diagnosis
    date
    C2316983 (UMLS CUI [1])
    Item
    IWF lymphoma histology at initial diagnosis
    integer
    C0019638 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    IWF lymphoma histology
    Code List
    IWF lymphoma histology at initial diagnosis
    CL Item
    small lymphocytic (with or without plasmacytoid differentiation) (1)
    CL Item
    follicular, small-cleaved (2)
    CL Item
    follicular, mixed small-cleaved and follicular, large cell (<50% large cell component) (3)
    CL Item
    follicular, large cell (4)
    Transformation
    Item
    Has transformation occurred?
    boolean
    C1510411 (UMLS CUI [1])
    Item
    If Yes:
    integer
    C1510411 (UMLS CUI [1])
    Transformation
    Code List
    If Yes:
    CL Item
    Intermediate-grade (1)
    CL Item
    High-grade (2)
    Date of transformation
    Item
    Date of transformation
    date
    C0011008 (UMLS CUI [1,1])
    C1510411 (UMLS CUI [1,2])
    Item
    Sites of disease at protocol entry:
    integer
    C0027653 (UMLS CUI [1])
    Sites of disease
    Code List
    Sites of disease at protocol entry:
    CL Item
    Head (1)
    CL Item
    Neck (2)
    CL Item
    Chest (3)
    CL Item
    Abdomen (4)
    CL Item
    Pelvis (5)
    CL Item
    Skin (6)
    CL Item
    Other (7)
    CD20 Positivity
    Item
    Does the patient have evidence that they tumor tissue expresses the CD20 antigen? Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity with Anti-B1-Antibody (Coulter Clone) or similar commercially-available CD20 antibody (greater than 50% of tumor cells are positive) are acceptable evidence of CD20 positivity.
    boolean
    C0054946 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    Rituximab therapy
    Item
    Was the patient treated with at least 4 doses of rituximab at any time and failed to achieve an objective response (CR, CCR, PR), or relapsed/progressed during treatment or following the completion of rituximab therapy?
    boolean
    C1514463 (UMLS CUI [1,1])
    C0393022 (UMLS CUI [1,2])
    Number of rituximab doses
    Item
    Number of rituximab therapy doses received
    integer
    C0178602 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    C0393022 (UMLS CUI [1,3])
    Item
    Effect of rituximab therapy
    integer
    C1514463 (UMLS CUI [1,1])
    C0393022 (UMLS CUI [1,2])
    Effect of rituximab therapy
    Code List
    Effect of rituximab therapy
    CL Item
    progression (1)
    CL Item
    non-response (2)
    Karnofsky Scale and life expectancy
    Item
    Does the patient have a performance status of at least 60 on the Karnofsky Scale and an anticipated survival of at least three months?
    boolean
    C0206065 (UMLS CUI [1,1])
    C0023671 (UMLS CUI [1,2])
    Granulocyte and platelet count
    Item
    Does the patient have an absolute granulocyte count >1,500 cells/mm³ and a platelet count >100,000 cells/mm³ within 14 days of study entry? These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
    boolean
    C0857490 (UMLS CUI [1,1])
    C0005821 (UMLS CUI [1,2])
    Date of blood sample
    Item
    Date
    date
    C0022885 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    ANC
    Item
    ANC
    integer
    C0948762 (UMLS CUI [1])
    Platelet count
    Item
    Platelet count
    integer
    C0005821 (UMLS CUI [1])
    Renal and hepatic function
    Item
    Does the patient have adequate renal function (defined as serum creatinine <1,5 x upper limit of normal) and hepatic function [defined ad total bilirubin <1,5 x upper limit of normal and transaminase (AST and ALT) <5 x upper limit of normal] within 14 days of study entry?
    boolean
    C0232804 (UMLS CUI [1,1])
    C0232741 (UMLS CUI [1,2])
    Date of laboratory tests
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    Creatinine
    Item
    Creatinine
    float
    C0201976 (UMLS CUI [1])
    Bilirubin
    Item
    Bilirubin
    float
    C1278039 (UMLS CUI [1])
    AST
    Item
    AST
    float
    C0201899 (UMLS CUI [1])
    ALT
    Item
    ALT
    float
    C0201836 (UMLS CUI [1])
    Bi-dimensional measurable disease
    Item
    Does the patient have bi-dimensional measurable disease? At least one lesion must be ≥ 2x2 cm.
    boolean
    C1513041 (UMLS CUI [1,1])
    C1705052 (UMLS CUI [1,2])
    Age
    Item
    Is the patient at least 18 years of age?
    boolean
    C0001779 (UMLS CUI [1])
    Informed consent
    Item
    Has the patient signed the IRB-approved written informed consent form prior to study entry?
    boolean
    C0021430 (UMLS CUI [1])
    Date of informed consent
    Item
    Date consent signed
    date
    C2985782 (UMLS CUI [1])
    Item Group
    Exclusion criteria
    C0680251 (UMLS CUI-1)
    Bone marrow involved in Lymphoma
    Item
    Does the patient have an average of >25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically at study entry? Verification of bone marrow status is required within 42 days of initial study entry. Bilateral posterior iliac crest core biopsies are required if the percentage of intratrabecular space involved exceeds 10% on a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.
    boolean
    C1517677 (UMLS CUI [1])
    C0005954 (UMLS CUI [2])
    Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment
    Item
    Has the patient received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (six weeks for nitrosourea compounds) or continued to exhibit clinical evidence of toxicity? The use of glucocorticoids must be discontinued (except maintenance dose steroids) at least 1 week prior to study entry.
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    C0021081 (UMLS CUI [3])
    C0199974 (UMLS CUI [4])
    Stem cell transplant and chemo/radiotherapy
    Item
    Has the patient undergone prior hematopoietic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy?
    boolean
    C3874407 (UMLS CUI [1,1])
    C0279134 (UMLS CUI [1,2])
    Obstructive hydronephrosis
    Item
    Does the patient have active obstructive hydronephrosis?
    boolean
    C0020295 (UMLS CUI [1,1])
    C0549186 (UMLS CUI [1,2])
    Active infection
    Item
    Does the patient have evidence of active infection requiring intravenous antibiotics at the time of study entry?
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205177 (UMLS CUI [1,2])
    NYHA heart disease
    Item
    Does the patient have New York Heart Association class III or IV heart disease or another serious illness that would preclude evaluation?
    boolean
    C0018799 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
    Cancer history
    Item
    Has the patient had prior malignancy other than lymphoma, except for adequately-treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 Years?
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    HIV infection
    Item
    Does the patient have known HIV infection?
    boolean
    C0019693 (UMLS CUI [1])
    Brain or leptomeningeal metastases
    Item
    Does the patient have known brain or leptomeningeal metastases?
    boolean
    C0220650 (UMLS CUI [1,1])
    C1704231 (UMLS CUI [1,2])
    Pregnancy or nursing
    Item
    Is the patient pregnant or nursing? Patient of childbearing potential mist have a negative pregnancy test result within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Allergic reactions to iodine
    Item
    Has the patient had previous allergic reactions to iodine (with the exception of reactions to intravenous iodine-containing contrast materials)?
    boolean
    C0020517 (UMLS CUI [1,1])
    C0021968 (UMLS CUI [1,2])
    Radioimmunotherapy
    Item
    Has the patient previously received radioimmunotherapy?
    boolean
    C0085101 (UMLS CUI [1])
    Progressive disease in field of irradiation
    Item
    Has the patient had progressive disease within one year of irradiation arising in a field that has been previously irradiated with >3500 cGy?
    boolean
    C1335499 (UMLS CUI [1,1])
    C2169147 (UMLS CUI [1,2])
    HAMA positivity
    Item
    Is the patient HAMA-positive?
    boolean
    C3541258 (UMLS CUI [1])
    Anti-cancer drugs or biologics
    Item
    Is the patient receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
    boolean
    C0920425 (UMLS CUI [1])
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Signature
    Item
    Investigator signature
    text
    C2346576 (UMLS CUI [1])
    Signature date
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Patient Enrollment Authorized
    Item
    Patient Enrollment Authorized by
    text
    C1555472 (UMLS CUI [1,1])
    C2700391 (UMLS CUI [1,2])
    C4041024 (UMLS CUI [1,3])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0680281 (UMLS CUI [1,2])
    Item
    Approved dose
    integer
    C0178602 (UMLS CUI [1,1])
    C0205540 (UMLS CUI [1,2])
    Approved dose
    Code List
    Approved dose
    CL Item
    65 cGy (1)
    CL Item
    75 cGy (2)
    Adjust mCi dose
    Item
    Adjust mCi dose for obesity
    boolean
    C1707811 (UMLS CUI [1])
    Volver a la parte superior de la página 

    Ayuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial