ID

22319

Descripción

Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Disease History Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Link

https://clinicaltrials.gov/ct2/show/NCT00078572

Palabras clave

Versiones (1)
  1. 29/5/17 29/5/17 -
Subido en

29 de mayo de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572

    Inglés

    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572

    1 formularios  
    Disease History Screening
    Descripción

    Disease History Screening

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C1710477
    Subject number
    Descripción

    Subject number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of first diagnosis of breast cancer
    Descripción

    Date of first diagnosis of breast cancer

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C0678222
    Date of first diagnosis of metastatic breast cancer
    Descripción

    Date of first diagnosis of metastatic breast cancer

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C0027627
    UMLS CUI [1,3]
    C0678222
    Histology at first diagnosis, check one:
    Descripción

    Histology at first diagnosis

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0019638
    UMLS CUI [1,2]
    C0678222
    Estrogen Receptor Status
    Descripción

    Estrogen Receptor Status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1719706
    UMLS CUI [1,2]
    C1719707
    Progesterone Receptor Status
    Descripción

    Progesterone Receptor Status

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1514471
    Archived Tumor Tissue: HER2/neu overexpression status (defined as +3 by IHC or +2 by IHC and FISH+.)
    Descripción

    HER2/neu overexpression status

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1512413
    Stage of disease at first diagnosis, check one:
    Descripción

    Stage of disease at first diagnosis

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1300072
    UMLS CUI [1,2]
    C3172269
    UMLS CUI [1,3]
    C0678222
    Current stage of disease, check one:
    Descripción

    Current stage of disease

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1300072
    UMLS CUI [1,2]
    C0678222
    Current site of disease, check one:
    Descripción

    Site of disease

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0450429
    UMLS CUI [1,2]
    C0678222
    For subjects who have had surgery: Is there local recurrence of the original disease?
    Descripción

    local recurrence of the original disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0034897
    UMLS CUI [1,2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Abdomen/viscera
    Descripción

    metastatic disease site Abdomen/viscera

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0000726
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Adrenals
    Descripción

    metastatic disease site Adrenals

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0001625
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Bone
    Descripción

    metastatic disease site Bone

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262950
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Bone marrow
    Descripción

    metastatic disease site Bone marrow

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Breast
    Descripción

    metastatic disease site Breast

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0006141
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Chest Wall
    Descripción

    metastatic disease site Chest Wall

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205076
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: CNS
    Descripción

    metastatic disease site CNS

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0686377
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Heart
    Descripción

    metastatic disease site Heart

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0018787
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Liver
    Descripción

    metastatic disease site Liver

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0023884
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Lung
    Descripción

    metastatic disease site Lung

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0024109
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Lymph nodes
    Descripción

    metastatic disease site Lymph nodes

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0024204
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Pancreas
    Descripción

    metastatic disease site Pancreas

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0030274
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Peritoneum
    Descripción

    metastatic disease site Peritoneum

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0031153
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Pleura
    Descripción

    metastatic disease site Pleura

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0032225
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Skin
    Descripción

    metastatic disease site Skin

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1123023
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Stomach
    Descripción

    metastatic disease site Stomach

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0038351
    UMLS CUI [1,2]
    C0036525
    UMLS CUI [2]
    C0678222
    Is (are) there any current known metastatic disease site(s) in the: Other, specify
    Descripción

    metastatic disease site

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0036525
    UMLS CUI [2]
    C0678222
    Prior Anti-Cancer Surgery Screening
    Descripción

    Prior Anti-Cancer Surgery Screening

    Alias
    UMLS CUI-1
    C0543467
    UMLS CUI-2
    C0920425
    Has this subject received surgery for the cancer under study?
    Descripción

    received surgery for the cancer

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0920425
    Date of surgery
    Descripción

    If YES, record in chronological order below:

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0543467
    Procedure
    Descripción

    Procedure

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0184661
    Prior Anti-Cancer Systemic Therapy Screening
    Descripción

    Prior Anti-Cancer Systemic Therapy Screening

    Alias
    UMLS CUI-1
    C1515119
    UMLS CUI-2
    C0920425
    Has this subject received prior anti-cancer systemic therapy for the cancer under study?
    Descripción

    prior anti-cancer systemic therapy for the cancer

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1515119
    UMLS CUI [1,2]
    C0920425
    Regimen no
    Descripción

    If NO, leave remainder of page blank. If YES, record, in chronological order, all prior therapies for the cancer under study.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0040808
    UMLS CUI [1,2]
    C0237753
    Therapy
    Descripción

    Therapy

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1515119
    Intent
    Descripción

    Intent

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1283828
    UMLS CUI [1,2]
    C1515119
    No. of cycles
    Descripción

    No. of cycles

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1515119
    UMLS CUI [1,2]
    C0750480
    Total cumulative dose of Anthracycline (mg/m2)
    Descripción

    Total cumulative dose of Anthracycline

    Tipo de datos

    float

    Unidades de medida
    • mg/m2
    Alias
    UMLS CUI [1,1]
    C0003234
    UMLS CUI [1,2]
    C3174092
    UMLS CUI [2]
    C1515119
    mg/m2
    Date started
    Descripción

    Date started

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1515119
    Date stopped
    Descripción

    Date stopped

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1515119
    Best response
    Descripción

    Best response

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2986560
    UMLS CUI [1,2]
    C1515119
    Date of progression
    Descripción

    Date of progression

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0242656
    UMLS CUI [1,3]
    C1515119
    Prior Anti-Cancer Radiotherapy Screening
    Descripción

    Prior Anti-Cancer Radiotherapy Screening

    Alias
    UMLS CUI-1
    C1522449
    UMLS CUI-2
    C0920425
    Has this subject received prior radiotherapy for the cancer under study?
    Descripción

    prior radiotherapy for the cancer

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0920425
    Site
    Descripción

    If YES, record in chronological order below.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C1522449
    Date started
    Descripción

    Date started

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1522449
    Date stopped
    Descripción

    Date stopped

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1522449
    Estimated total dose: amount
    Descripción

    Estimated total dose amount

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C1265611
    Estimated total dose: units
    Descripción

    Estimated total dose units

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1519795
    Best response
    Descripción

    Best response

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2986560
    UMLS CUI [1,2]
    C1522449
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    Similar models

    XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Disease History Screening
    C0262926 (UMLS CUI-1)
    C1710477 (UMLS CUI-2)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Date of first diagnosis of breast cancer
    Item
    Date of first diagnosis of breast cancer
    date
    C2316983 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])
    Date of first diagnosis of metastatic breast cancer
    Item
    Date of first diagnosis of metastatic breast cancer
    date
    C2316983 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [1,3])
    Item
    Histology at first diagnosis, check one:
    text
    C0019638 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])
    Histology at first diagnosis
    Code List
    Histology at first diagnosis, check one:
    CL Item
    Infiltrating Duct NOS (IDN)
    CL Item
    Medullary (M)
    CL Item
    Lobular Invasive (LI)
    CL Item
    Mucinous (MU)
    CL Item
    Tubular (T)
    CL Item
    Adenocystic (A)
    CL Item
    Papillary (P)
    CL Item
    Carcinosarcoma (CA)
    CL Item
    Other, specify (X)
    Item
    Estrogen Receptor Status
    text
    C1719706 (UMLS CUI [1,1])
    C1719707 (UMLS CUI [1,2])
    Estrogen Receptor Status
    Code List
    Estrogen Receptor Status
    CL Item
    ER Positive (EP)
    CL Item
    ER Negative (EN)
    CL Item
    ER Status Not Available (EO)
    Item
    Progesterone Receptor Status
    text
    C1514471 (UMLS CUI [1])
    Progesterone Receptor Status
    Code List
    Progesterone Receptor Status
    CL Item
    PR Positive (PP)
    CL Item
    PR Negative (PN)
    CL Item
    PR Status Not Available (PO)
    Item
    Archived Tumor Tissue: HER2/neu overexpression status (defined as +3 by IHC or +2 by IHC and FISH+.)
    text
    C1512413 (UMLS CUI [1])
    HER2/neu overexpression status
    Code List
    Archived Tumor Tissue: HER2/neu overexpression status (defined as +3 by IHC or +2 by IHC and FISH+.)
    CL Item
    Overexpression (OE)
    CL Item
    Non-overexpression (NE)
    Item
    Stage of disease at first diagnosis, check one:
    integer
    C1300072 (UMLS CUI [1,1])
    C3172269 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [1,3])
    Stage of disease at first diagnosis
    Code List
    Stage of disease at first diagnosis, check one:
    CL Item
    Stage I (1)
    CL Item
    Stage II (2)
    CL Item
    Stage III (3)
    CL Item
    Stage IV (4)
    Item
    Current stage of disease, check one:
    integer
    C1300072 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])
    Current stage of disease
    Code List
    Current stage of disease, check one:
    CL Item
    Stage IIIb or Stage IIIc with T4 lesion (1)
    CL Item
    Stage IV (2)
    Item
    Current site of disease, check one:
    text
    C0450429 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])
    Site of disease
    Code List
    Current site of disease, check one:
    CL Item
    Visceral (V)
    CL Item
    Non-Visceral (NV)
    local recurrence of the original disease
    Item
    For subjects who have had surgery: Is there local recurrence of the original disease?
    boolean
    C0034897 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])
    metastatic disease site Abdomen/viscera
    Item
    Is (are) there any current known metastatic disease site(s) in the: Abdomen/viscera
    boolean
    C0000726 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Adrenals
    Item
    Is (are) there any current known metastatic disease site(s) in the: Adrenals
    boolean
    C0001625 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Bone
    Item
    Is (are) there any current known metastatic disease site(s) in the: Bone
    boolean
    C0262950 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Bone marrow
    Item
    Is (are) there any current known metastatic disease site(s) in the: Bone marrow
    boolean
    C0005953 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Breast
    Item
    Is (are) there any current known metastatic disease site(s) in the: Breast
    boolean
    C0006141 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Chest Wall
    Item
    Is (are) there any current known metastatic disease site(s) in the: Chest Wall
    boolean
    C0205076 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site CNS
    Item
    Is (are) there any current known metastatic disease site(s) in the: CNS
    boolean
    C0686377 (UMLS CUI [1])
    C0678222 (UMLS CUI [2])
    metastatic disease site Heart
    Item
    Is (are) there any current known metastatic disease site(s) in the: Heart
    boolean
    C0018787 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Liver
    Item
    Is (are) there any current known metastatic disease site(s) in the: Liver
    boolean
    C0023884 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Lung
    Item
    Is (are) there any current known metastatic disease site(s) in the: Lung
    boolean
    C0024109 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Lymph nodes
    Item
    Is (are) there any current known metastatic disease site(s) in the: Lymph nodes
    boolean
    C0024204 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Pancreas
    Item
    Is (are) there any current known metastatic disease site(s) in the: Pancreas
    boolean
    C0030274 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Peritoneum
    Item
    Is (are) there any current known metastatic disease site(s) in the: Peritoneum
    boolean
    C0031153 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Pleura
    Item
    Is (are) there any current known metastatic disease site(s) in the: Pleura
    boolean
    C0032225 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Skin
    Item
    Is (are) there any current known metastatic disease site(s) in the: Skin
    boolean
    C1123023 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site Stomach
    Item
    Is (are) there any current known metastatic disease site(s) in the: Stomach
    boolean
    C0038351 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2])
    metastatic disease site
    Item
    Is (are) there any current known metastatic disease site(s) in the: Other, specify
    text
    C0036525 (UMLS CUI [1])
    C0678222 (UMLS CUI [2])
    Item Group
    Prior Anti-Cancer Surgery Screening
    C0543467 (UMLS CUI-1)
    C0920425 (UMLS CUI-2)
    Item
    Has this subject received surgery for the cancer under study?
    text
    C0543467 (UMLS CUI [1,1])
    C0920425 (UMLS CUI [1,2])
    received surgery for the cancer
    Code List
    Has this subject received surgery for the cancer under study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of surgery
    Item
    Date of surgery
    date
    C0011008 (UMLS CUI [1,1])
    C0543467 (UMLS CUI [1,2])
    Procedure
    Item
    Procedure
    text
    C0184661 (UMLS CUI [1])
    Item Group
    Prior Anti-Cancer Systemic Therapy Screening
    C1515119 (UMLS CUI-1)
    C0920425 (UMLS CUI-2)
    Item
    Has this subject received prior anti-cancer systemic therapy for the cancer under study?
    text
    C1515119 (UMLS CUI [1,1])
    C0920425 (UMLS CUI [1,2])
    received surgery for the cancer
    Code List
    Has this subject received prior anti-cancer systemic therapy for the cancer under study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Regimen no
    Item
    Regimen no
    text
    C0040808 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Therapy
    Item
    Therapy
    text
    C1515119 (UMLS CUI [1])
    Item
    Intent
    text
    C1283828 (UMLS CUI [1,1])
    C1515119 (UMLS CUI [1,2])
    Intent
    Code List
    Intent
    CL Item
    Neo-adjuvant (N )
    CL Item
    Adjuvant (A )
    CL Item
    Advanced or metastatic  (M )
    CL Item
    Not applicable (NA )
    No. of cycles
    Item
    No. of cycles
    text
    C1515119 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Total cumulative dose of Anthracycline
    Item
    Total cumulative dose of Anthracycline (mg/m2)
    float
    C0003234 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    C1515119 (UMLS CUI [2])
    Date started
    Item
    Date started
    date
    C0808070 (UMLS CUI [1,1])
    C1515119 (UMLS CUI [1,2])
    Date stopped
    Item
    Date stopped
    date
    C0806020 (UMLS CUI [1,1])
    C1515119 (UMLS CUI [1,2])
    Item
    Best response
    text
    C2986560 (UMLS CUI [1,1])
    C1515119 (UMLS CUI [1,2])
    Best response
    Code List
    Best response
    CL Item
    Complete response (CR )
    CL Item
    Partial response (PR )
    CL Item
    Stable disease (SD )
    CL Item
    Progressive disease (PD )
    CL Item
    Unknown (UNK )
    CL Item
    Not applicable (e.g., adjuvant therapy) (NA )
    Date of progression
    Item
    Date of progression
    date
    C0011008 (UMLS CUI [1,1])
    C0242656 (UMLS CUI [1,2])
    C1515119 (UMLS CUI [1,3])
    Item Group
    Prior Anti-Cancer Radiotherapy Screening
    C1522449 (UMLS CUI-1)
    C0920425 (UMLS CUI-2)
    Item
    Has this subject received prior radiotherapy for the cancer under study?
    text
    C1522449 (UMLS CUI [1,1])
    C0920425 (UMLS CUI [1,2])
    received surgery for the cancer
    Code List
    Has this subject received prior radiotherapy for the cancer under study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Site
    Item
    Site
    text
    C1515974 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    Date started
    Item
    Date started
    date
    C0808070 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    Date stopped
    Item
    Date stopped
    date
    C0806020 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    Estimated total dose amount
    Item
    Estimated total dose: amount
    float
    C1522449 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    Estimated total dose units
    Item
    Estimated total dose: units
    text
    C1522449 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Item
    Best response
    text
    C2986560 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    Best response
    Code List
    Best response
    CL Item
    Complete response (CR )
    CL Item
    Partial response (PR )
    CL Item
    Stable disease (SD )
    CL Item
    Progressive disease (PD )
    CL Item
    Unknown (UNK )
    CL Item
    Not applicable (e.g., adjuvant therapy) (NA )
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