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ID

43811

Descripción

Study part: Prognostic factors. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

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Versiones (2)
  1. 16/5/17 16/5/17 -
  2. 20/9/21 20/9/21 -
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Roche

Subido en

20 de septiembre de 2021

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Creative Commons BY-NC 3.0
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    PROGNOSTIC FACTORS Roche H0650g Breast Cancer

    Inglés

    PROGNOSTIC FACTORS

    1 formularios  
    1. StudyEvent: ODM
      1. PROGNOSTIC FACTORS
    PROGNOSTIC FACTORS
    Descripción

    PROGNOSTIC FACTORS

    Alias
    UMLS CUI-1
    C1514474
    1. MENOPAUSAL STATUS AT TIME OF PRIMARY DIAGNOSIS:
    Descripción

    MENOPAUSAL STATUS; PRIMARY DIAGNOSIS

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0455962
    UMLS CUI [2]
    C0332137
    2. SIZE OF PRIMARY TUMOR FROM PATHOLOGY OR SURGERY REPORT:
    Descripción

    Primary tumor size; Pathology report; Surgery report

    Tipo de datos

    text

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C1302656
    UMLS CUI [2]
    C0807321
    UMLS CUI [3]
    C4291713
    cm
    3. HISTOLOGY OF PRIMARY TUMOR: 1. INFILTRATING DUCTAL CARCINOMA
    Descripción

    histology primary tumor; Infiltrating duct and lobular carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0334384
    3. HISTOLOGY OF PRIMARY TUMOR: 2. INFILTRATING LOBULAR CARCINOMA
    Descripción

    histology primary tumor; Infiltrating duct and lobular carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0334384
    3. HISTOLOGY OF PRIMARY TUMOR: 3. MEDULLARY CARCINOMA
    Descripción

    histology primary tumor; Medullary carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0206693
    3. HISTOLOGY OF PRIMARY TUMOR: 4. COLLOID CARCINOMA
    Descripción

    histology primary tumor; Colloid carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0007130
    3. HISTOLOGY OF PRIMARY TUMOR: 5. INFILTRATING COMEDOCARCINOMA
    Descripción

    histology primary tumor; Comedocarcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0334370
    3. HISTOLOGY OF PRIMARY TUMOR: 6. INFILTRATING BREAST CARCINOMA
    Descripción

    histology primary tumor; Invasive carcinoma of breast

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0853879
    3.HISTOLOGY OF PRIMARY TUMOR: 7. PAGET'S DISEASE
    Descripción

    histology primary tumor; Paget Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C1368019
    3. HISTOLOGY OF PRIMARY TUMOR:8. DUCTAL CARCINOMA IN SITU
    Descripción

    histology primary tumor; Ductal carcinoma in situ

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C1266028
    3. HISTOLOGY OF PRIMARY TUMOR: 9. LOBULAR CARCINOMA IN SITU
    Descripción

    histology primary tumor; Lobular carcinoma in situ of breast

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0279563
    3. HISTOLOGY OF PRIMARY TUMOR: 10. MUCINOUS CARCINOMA
    Descripción

    histology primary tumor; Mucinous carcinoma of breast

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C1334807
    3. HISTOLOGY OF PRIMARY TUMOR: 11. INFLAMMATORY CARCINOMA
    Descripción

    histology primary tumor; Inflammatory carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0334385
    3. HISTOLOGY OF PRIMARY TUMOR: 12. OTHER (SPECIFY):
    Descripción

    histology primary tumor; other

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0205394
    3. HISTOLOGY OF PRIMARY TUMOR: 13. NOT AVAILABLE
    Descripción

    histology primary tumor; not available

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0677930
    UMLS CUI [2]
    C0686905
    4. ESTROGEN RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
    Descripción

    Status Estrogen Receptors; Primary diagnosis

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0449438
    UMLS CUI [1,2]
    C0034804
    UMLS CUI [2]
    C0332137
    5. PROGESTERONE RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
    Descripción

    Progesterone Receptor Status; Primary diagnosis

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1514471
    UMLS CUI [2]
    C0332137
    6. AXILLARY NODES AT TIME OF PRIMARY DIAGNOSIS:
    Descripción

    Principal diagnosis

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0729594
    UMLS CUI [2]
    C0332137
    6. IF YES, NUMBER OF NODES EXAMINED
    Descripción

    Number of lymph nodes examined

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2733494
    6. IF YES, NUMBER OF EXAMINED NODES WHICH WERE POSITIVE
    Descripción

    Number of Lymph Nodes Positive

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C4086646
    7. DO ANY IMMEDIATE FAMILY MEMBERS HAVE A HISTORY OF BREAST CANCER?
    Descripción

    family medical history breast cancer

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0006142
    7. IF YES, GRANDMOTHER (MATERNAL)?
    Descripción

    family medical history breast cancer; Maternal grandmother

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0006142
    UMLS CUI [2]
    C1273525
    7. IF YES, GRANDMOTHER (PATERNAL)?
    Descripción

    family medical history breast cancer; Paternal grandmother

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0006142
    UMLS CUI [2]
    C1273524
    7. IF YES, MOTHER?
    Descripción

    family medical history breast cancer; Mother

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0006142
    UMLS CUI [2]
    C0026591
    7. IF YES, SISTER?
    Descripción

    family medical history breast cancer; Sister

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0006142
    UMLS CUI [2]
    C0337514
    7. IF YES, DAUGHTER?
    Descripción

    family medical history breast cancer; Daughter

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0006142
    UMLS CUI [2]
    C0011011
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    Similar models

    PROGNOSTIC FACTORS

    1 formularios
    1. StudyEvent: ODM
      1. PROGNOSTIC FACTORS
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    PROGNOSTIC FACTORS
    C1514474 (UMLS CUI-1)
    Item
    1. MENOPAUSAL STATUS AT TIME OF PRIMARY DIAGNOSIS:
    integer
    C0455962 (UMLS CUI [1])
    C0332137 (UMLS CUI [2])
    MENOPAUSAL STATUS; PRIMARY DIAGNOSIS
    Code List
    1. MENOPAUSAL STATUS AT TIME OF PRIMARY DIAGNOSIS:
    CL Item
    PREMENOPAUSAL  (1)
    CL Item
    PERIMENOPAUSAL  (2)
    CL Item
    POSTMENOPAUSAL (3)
    Primary tumor size; Pathology report; Surgery report
    Item
    2. SIZE OF PRIMARY TUMOR FROM PATHOLOGY OR SURGERY REPORT:
    text
    C1302656 (UMLS CUI [1])
    C0807321 (UMLS CUI [2])
    C4291713 (UMLS CUI [3])
    histology primary tumor; Infiltrating duct and lobular carcinoma
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 1. INFILTRATING DUCTAL CARCINOMA
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0334384 (UMLS CUI [2])
    histology primary tumor; Infiltrating duct and lobular carcinoma
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 2. INFILTRATING LOBULAR CARCINOMA
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0334384 (UMLS CUI [2])
    histology primary tumor; Medullary carcinoma
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 3. MEDULLARY CARCINOMA
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0206693 (UMLS CUI [2])
    histology primary tumor; Colloid carcinoma
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 4. COLLOID CARCINOMA
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0007130 (UMLS CUI [2])
    histology primary tumor; Comedocarcinoma
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 5. INFILTRATING COMEDOCARCINOMA
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0334370 (UMLS CUI [2])
    histology primary tumor; Invasive carcinoma of breast
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 6. INFILTRATING BREAST CARCINOMA
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0853879 (UMLS CUI [2])
    histology primary tumor; Paget Disease
    Item
    3.HISTOLOGY OF PRIMARY TUMOR: 7. PAGET'S DISEASE
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C1368019 (UMLS CUI [2])
    histology primary tumor; Ductal carcinoma in situ
    Item
    3. HISTOLOGY OF PRIMARY TUMOR:8. DUCTAL CARCINOMA IN SITU
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C1266028 (UMLS CUI [2])
    histology primary tumor; Lobular carcinoma in situ of breast
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 9. LOBULAR CARCINOMA IN SITU
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0279563 (UMLS CUI [2])
    histology primary tumor; Mucinous carcinoma of breast
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 10. MUCINOUS CARCINOMA
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C1334807 (UMLS CUI [2])
    histology primary tumor; Inflammatory carcinoma
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 11. INFLAMMATORY CARCINOMA
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0334385 (UMLS CUI [2])
    histology primary tumor; other
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 12. OTHER (SPECIFY):
    text
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [2])
    histology primary tumor; not available
    Item
    3. HISTOLOGY OF PRIMARY TUMOR: 13. NOT AVAILABLE
    boolean
    C0019638 (UMLS CUI [1,1])
    C0677930 (UMLS CUI [1,2])
    C0686905 (UMLS CUI [2])
    Item
    4. ESTROGEN RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
    integer
    C0449438 (UMLS CUI [1,1])
    C0034804 (UMLS CUI [1,2])
    C0332137 (UMLS CUI [2])
    Status Estrogen Receptors; Primary diagnosis
    Code List
    4. ESTROGEN RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
    CL Item
    POSITIVE (1)
    CL Item
    NEGATIVE (2)
    CL Item
    NOT AVAILABLE (3)
    Item
    5. PROGESTERONE RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
    integer
    C1514471 (UMLS CUI [1])
    C0332137 (UMLS CUI [2])
    Status Estrogen Receptors; Primary diagnosis
    Code List
    5. PROGESTERONE RECEPTOR STATUS AT TIME OF PRIMARY DIAGNOSIS:
    CL Item
    POSITIVE (1)
    CL Item
    NEGATIVE (2)
    CL Item
    NOT AVAILABLE (3)
    Item
    6. AXILLARY NODES AT TIME OF PRIMARY DIAGNOSIS:
    integer
    C0729594 (UMLS CUI [1])
    C0332137 (UMLS CUI [2])
    Status Estrogen Receptors; Primary diagnosis
    Code List
    6. AXILLARY NODES AT TIME OF PRIMARY DIAGNOSIS:
    CL Item
    POSITIVE (1)
    CL Item
    NEGATIVE (2)
    CL Item
    NOT AVAILABLE (3)
    Number of lymph nodes examined
    Item
    6. IF YES, NUMBER OF NODES EXAMINED
    integer
    C2733494 (UMLS CUI [1])
    Number of Lymph Nodes Positive
    Item
    6. IF YES, NUMBER OF EXAMINED NODES WHICH WERE POSITIVE
    integer
    C4086646 (UMLS CUI [1])
    Item
    7. DO ANY IMMEDIATE FAMILY MEMBERS HAVE A HISTORY OF BREAST CANCER?
    integer
    C0241889 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0006142 (UMLS CUI [1,3])
    family medical history breast cancer
    Code List
    7. DO ANY IMMEDIATE FAMILY MEMBERS HAVE A HISTORY OF BREAST CANCER?
    CL Item
    YES (1)
    CL Item
    NO (2)
    CL Item
    UNKNOWN (3)
    family medical history breast cancer; Maternal grandmother
    Item
    7. IF YES, GRANDMOTHER (MATERNAL)?
    boolean
    C0241889 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0006142 (UMLS CUI [1,3])
    C1273525 (UMLS CUI [2])
    family medical history breast cancer; Paternal grandmother
    Item
    7. IF YES, GRANDMOTHER (PATERNAL)?
    boolean
    C0241889 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0006142 (UMLS CUI [1,3])
    C1273524 (UMLS CUI [2])
    family medical history breast cancer; Mother
    Item
    7. IF YES, MOTHER?
    boolean
    C0241889 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0006142 (UMLS CUI [1,3])
    C0026591 (UMLS CUI [2])
    family medical history breast cancer; Sister
    Item
    7. IF YES, SISTER?
    boolean
    C0241889 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0006142 (UMLS CUI [1,3])
    C0337514 (UMLS CUI [2])
    family medical history breast cancer; Daughter
    Item
    7. IF YES, DAUGHTER?
    boolean
    C0241889 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0006142 (UMLS CUI [1,3])
    C0011011 (UMLS CUI [2])
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