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])
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])