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ID

41563

Description

A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01079676

Link

https://clinicaltrials.gov/show/NCT01079676

Keywords

Versions (1)
  1. 11/11/20 11/11/20 -
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see on clinicaltrials.gov

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November 11, 2020

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Creative Commons BY 4.0
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    Eligibility Neutropenia in Breast Cancer NCT01079676

    English

    Eligibility Neutropenia in Breast Cancer NCT01079676

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    signed icf;
    Description

    signed informed consent form

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer;
    Description

    diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C1265900
    UMLS CUI [2,1]
    C0678222
    UMLS CUI [2,2]
    C0449575
    clinical or imaging confirmation of stage II to IV disease, according to the tnm classification;
    Description

    clinical or imaging confirmation of TNM Breast Tumor staging

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1456356
    UMLS CUI [1,2]
    C0474926
    UMLS CUI [2,1]
    C0011923
    UMLS CUI [2,2]
    C0474926
    indication for chemotherapy with one of the eligible regimens, as long as the treatment in the first cycle is planned as full dose (without adjustments relative to the original regimen)
    Description

    indication for chemotherapy with one of the eligible regimens except for relative dose adjustments in the first cycle

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C1548635
    UMLS CUI [1,3]
    C0392920
    UMLS CUI [2,1]
    C0332300
    UMLS CUI [2,2]
    C2826232
    UMLS CUI [2,3]
    C0205435
    UMLS CUI [2,4]
    C1302181
    performance status from 0 to 1 on the zubrod scale
    Description

    performance status on the zubrod scale

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3714786
    no more than one previous chemotherapeutic regimen for metastatic disease
    Description

    no more than one previous chemotherapeutic regimen for metastatic disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205156
    UMLS CUI [1,2]
    C0392920
    UMLS CUI [1,3]
    C0027627
    UMLS CUI [1,4]
    C0332300
    UMLS CUI [1,5]
    C0439064
    proper organic functions, as indicated by all the following conditions: anc >1500/mm3, platelet count >150000/mm3, serum creatinine <1,2 mg/dl, bilirubins and transaminases (aspartate aminotransferase [ast] and alanine aminotransferase [alt]) <1.5 times the upper limit of normal
    Description

    proper organic functions, as indicated by: anc >1500/mm3, platelet count >150000/mm3, serum creatinine <1,2 mg/dl, bilirubins and transaminases (aspartate aminotransferase [ast] and alanine aminotransferase [alt]) <1.5 times the upper limit of normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2]
    C0032181
    UMLS CUI [3]
    C0201976
    UMLS CUI [4]
    C0005437
    UMLS CUI [5]
    C0201899
    UMLS CUI [6]
    C0201836
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    forecast of prophylactic or therapeutic use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy;
    Description

    forecast of use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0681842
    UMLS CUI [1,2]
    C0003232
    UMLS CUI [1,3]
    C0205435
    UMLS CUI [1,4]
    C1302181
    UMLS CUI [2,1]
    C0681842
    UMLS CUI [2,2]
    C0003308
    UMLS CUI [2,3]
    C0205435
    UMLS CUI [2,4]
    C1302181
    UMLS CUI [3,1]
    C0681842
    UMLS CUI [3,2]
    C2363964
    UMLS CUI [3,3]
    C0205435
    UMLS CUI [3,4]
    C1302181
    previous radiotherapy involving pelvis or radiotherapy of any site on the last 6 weeks before randomization;
    Description

    previous radiotherapy involving pelvis or recent radiotherapy of any site

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205156
    UMLS CUI [1,2]
    C1536155
    UMLS CUI [2,1]
    C0332185
    UMLS CUI [2,2]
    C1522449
    history of bone marrow transplantation (as receptor)
    Description

    history of bone marrow transplantation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005961
    presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous basal cell carcinoma properly treated, cutaneous spinocellular carcinoma properly treated, t1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
    Description

    presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous spinocellular carcinoma properly treated, t1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0027651
    UMLS CUI [2,1]
    C0332300
    UMLS CUI [2,2]
    C0851140
    UMLS CUI [3,1]
    C0332300
    UMLS CUI [3,2]
    C0007099
    UMLS CUI [3,3]
    C0005682
    UMLS CUI [4,1]
    C0332300
    UMLS CUI [4,2]
    C0007117
    UMLS CUI [4,3]
    C0087111
    UMLS CUI [4,4]
    C0205410
    UMLS CUI [5,1]
    C0332300
    UMLS CUI [5,2]
    C0553723
    UMLS CUI [5,3]
    C0087111
    UMLS CUI [5,4]
    C0205410
    UMLS CUI [6,1]
    C0332300
    UMLS CUI [6,2]
    C0042930
    UMLS CUI [6,3]
    C0006826
    UMLS CUI [6,4]
    C0475372
    UMLS CUI [6,5]
    C0544452
    UMLS CUI [7,1]
    C0332300
    UMLS CUI [7,2]
    C0006826
    UMLS CUI [7,3]
    C0205156
    UMLS CUI [7,4]
    C0087111
    UMLS CUI [8,1]
    C0332300
    UMLS CUI [8,2]
    C0006826
    UMLS CUI [8,3]
    C0332288
    UMLS CUI [8,4]
    C0035020
    presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, neurological, hematological, infectious, skin, neurological or psychiatric disease
    Description

    presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, hematological, infectious, skin, neurological or psychiatric disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205082
    UMLS CUI [1,2]
    C0009488
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C0007226
    UMLS CUI [3,1]
    C0009488
    UMLS CUI [3,2]
    C0264220
    UMLS CUI [4,1]
    C0009488
    UMLS CUI [4,2]
    C0022658
    UMLS CUI [5,1]
    C0009488
    UMLS CUI [5,2]
    C0023895
    UMLS CUI [6,1]
    C0009488
    UMLS CUI [6,2]
    C0027765
    UMLS CUI [7,1]
    C0009488
    UMLS CUI [7,2]
    C0018939
    UMLS CUI [8,1]
    C0009488
    UMLS CUI [8,2]
    C0151317
    UMLS CUI [9,1]
    C0009488
    UMLS CUI [9,2]
    C0275518
    UMLS CUI [10,1]
    C0009488
    UMLS CUI [10,2]
    C0037274
    UMLS CUI [11,1]
    C0009488
    UMLS CUI [11,2]
    C0004936
    recent (< 12 months) or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject, as per cns/ms resolution 251/97, item iii.j.
    Description

    recent or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C3274035
    UMLS CUI [2,1]
    C0681842
    UMLS CUI [2,2]
    C2348568
    UMLS CUI [2,3]
    C0205394
    UMLS CUI [2,4]
    C3274035
    UMLS CUI [3,1]
    C0332300
    UMLS CUI [3,2]
    C0814225
    UMLS CUI [3,3]
    C2348568
    intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study.
    Description

    intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1744706
    UMLS CUI [1,2]
    C1705248
    UMLS CUI [1,3]
    C0210630
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C1705248
    UMLS CUI [2,3]
    C0210630
    pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization).
    Description

    pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0022925
    UMLS CUI [3,1]
    C0332185
    UMLS CUI [3,2]
    C3831118
    UMLS CUI [3,3]
    C0430061
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    Similar models

    Eligibility Neutropenia in Breast Cancer NCT01079676

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    signed informed consent form
    Item
    signed icf;
    boolean
    C0021430 (UMLS CUI [1])
    diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer
    Item
    diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer;
    boolean
    C0678222 (UMLS CUI [1,1])
    C1265900 (UMLS CUI [1,2])
    C0678222 (UMLS CUI [2,1])
    C0449575 (UMLS CUI [2,2])
    clinical or imaging confirmation of TNM Breast Tumor staging
    Item
    clinical or imaging confirmation of stage II to IV disease, according to the tnm classification;
    boolean
    C1456356 (UMLS CUI [1,1])
    C0474926 (UMLS CUI [1,2])
    C0011923 (UMLS CUI [2,1])
    C0474926 (UMLS CUI [2,2])
    indication for chemotherapy with one of the eligible regimens except for relative dose adjustments in the first cycle
    Item
    indication for chemotherapy with one of the eligible regimens, as long as the treatment in the first cycle is planned as full dose (without adjustments relative to the original regimen)
    boolean
    C3146298 (UMLS CUI [1,1])
    C1548635 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [1,3])
    C0332300 (UMLS CUI [2,1])
    C2826232 (UMLS CUI [2,2])
    C0205435 (UMLS CUI [2,3])
    C1302181 (UMLS CUI [2,4])
    performance status on the zubrod scale
    Item
    performance status from 0 to 1 on the zubrod scale
    boolean
    C3714786 (UMLS CUI [1])
    no more than one previous chemotherapeutic regimen for metastatic disease
    Item
    no more than one previous chemotherapeutic regimen for metastatic disease
    boolean
    C0205156 (UMLS CUI [1,1])
    C0392920 (UMLS CUI [1,2])
    C0027627 (UMLS CUI [1,3])
    C0332300 (UMLS CUI [1,4])
    C0439064 (UMLS CUI [1,5])
    proper organic functions, as indicated by: anc >1500/mm3, platelet count >150000/mm3, serum creatinine <1,2 mg/dl, bilirubins and transaminases (aspartate aminotransferase [ast] and alanine aminotransferase [alt]) <1.5 times the upper limit of normal
    Item
    proper organic functions, as indicated by all the following conditions: anc >1500/mm3, platelet count >150000/mm3, serum creatinine <1,2 mg/dl, bilirubins and transaminases (aspartate aminotransferase [ast] and alanine aminotransferase [alt]) <1.5 times the upper limit of normal
    boolean
    C0948762 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    C0201976 (UMLS CUI [3])
    C0005437 (UMLS CUI [4])
    C0201899 (UMLS CUI [5])
    C0201836 (UMLS CUI [6])
    Item Group
    C0680251 (UMLS CUI)
    forecast of use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy
    Item
    forecast of prophylactic or therapeutic use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy;
    boolean
    C0681842 (UMLS CUI [1,1])
    C0003232 (UMLS CUI [1,2])
    C0205435 (UMLS CUI [1,3])
    C1302181 (UMLS CUI [1,4])
    C0681842 (UMLS CUI [2,1])
    C0003308 (UMLS CUI [2,2])
    C0205435 (UMLS CUI [2,3])
    C1302181 (UMLS CUI [2,4])
    C0681842 (UMLS CUI [3,1])
    C2363964 (UMLS CUI [3,2])
    C0205435 (UMLS CUI [3,3])
    C1302181 (UMLS CUI [3,4])
    previous radiotherapy involving pelvis or recent radiotherapy of any site
    Item
    previous radiotherapy involving pelvis or radiotherapy of any site on the last 6 weeks before randomization;
    boolean
    C0205156 (UMLS CUI [1,1])
    C1536155 (UMLS CUI [1,2])
    C0332185 (UMLS CUI [2,1])
    C1522449 (UMLS CUI [2,2])
    history of bone marrow transplantation
    Item
    history of bone marrow transplantation (as receptor)
    boolean
    C0005961 (UMLS CUI [1])
    presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous spinocellular carcinoma properly treated, t1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
    Item
    presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous basal cell carcinoma properly treated, cutaneous spinocellular carcinoma properly treated, t1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
    boolean
    C0205394 (UMLS CUI [1,1])
    C0027651 (UMLS CUI [1,2])
    C0332300 (UMLS CUI [2,1])
    C0851140 (UMLS CUI [2,2])
    C0332300 (UMLS CUI [3,1])
    C0007099 (UMLS CUI [3,2])
    C0005682 (UMLS CUI [3,3])
    C0332300 (UMLS CUI [4,1])
    C0007117 (UMLS CUI [4,2])
    C0087111 (UMLS CUI [4,3])
    C0205410 (UMLS CUI [4,4])
    C0332300 (UMLS CUI [5,1])
    C0553723 (UMLS CUI [5,2])
    C0087111 (UMLS CUI [5,3])
    C0205410 (UMLS CUI [5,4])
    C0332300 (UMLS CUI [6,1])
    C0042930 (UMLS CUI [6,2])
    C0006826 (UMLS CUI [6,3])
    C0475372 (UMLS CUI [6,4])
    C0544452 (UMLS CUI [6,5])
    C0332300 (UMLS CUI [7,1])
    C0006826 (UMLS CUI [7,2])
    C0205156 (UMLS CUI [7,3])
    C0087111 (UMLS CUI [7,4])
    C0332300 (UMLS CUI [8,1])
    C0006826 (UMLS CUI [8,2])
    C0332288 (UMLS CUI [8,3])
    C0035020 (UMLS CUI [8,4])
    presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, hematological, infectious, skin, neurological or psychiatric disease
    Item
    presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, neurological, hematological, infectious, skin, neurological or psychiatric disease
    boolean
    C0205082 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [2,1])
    C0007226 (UMLS CUI [2,2])
    C0009488 (UMLS CUI [3,1])
    C0264220 (UMLS CUI [3,2])
    C0009488 (UMLS CUI [4,1])
    C0022658 (UMLS CUI [4,2])
    C0009488 (UMLS CUI [5,1])
    C0023895 (UMLS CUI [5,2])
    C0009488 (UMLS CUI [6,1])
    C0027765 (UMLS CUI [6,2])
    C0009488 (UMLS CUI [7,1])
    C0018939 (UMLS CUI [7,2])
    C0009488 (UMLS CUI [8,1])
    C0151317 (UMLS CUI [8,2])
    C0009488 (UMLS CUI [9,1])
    C0275518 (UMLS CUI [9,2])
    C0009488 (UMLS CUI [10,1])
    C0037274 (UMLS CUI [10,2])
    C0009488 (UMLS CUI [11,1])
    C0004936 (UMLS CUI [11,2])
    recent or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject
    Item
    recent (< 12 months) or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject, as per cns/ms resolution 251/97, item iii.j.
    boolean
    C0332185 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C3274035 (UMLS CUI [1,4])
    C0681842 (UMLS CUI [2,1])
    C2348568 (UMLS CUI [2,2])
    C0205394 (UMLS CUI [2,3])
    C3274035 (UMLS CUI [2,4])
    C0332300 (UMLS CUI [3,1])
    C0814225 (UMLS CUI [3,2])
    C2348568 (UMLS CUI [3,3])
    intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study
    Item
    intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study.
    boolean
    C1744706 (UMLS CUI [1,1])
    C1705248 (UMLS CUI [1,2])
    C0210630 (UMLS CUI [1,3])
    C0020517 (UMLS CUI [2,1])
    C1705248 (UMLS CUI [2,2])
    C0210630 (UMLS CUI [2,3])
    pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization)
    Item
    pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization).
    boolean
    C0032961 (UMLS CUI [1])
    C0022925 (UMLS CUI [2])
    C0332185 (UMLS CUI [3,1])
    C3831118 (UMLS CUI [3,2])
    C0430061 (UMLS CUI [3,3])
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