ID.1
Item
if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
boolean
C0015780 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0015895 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
ID.2
Item
eighteen years of age or older
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
karnofsky perfomance status of 70% or 0-2 swog performance status
boolean
C0206065 (UMLS CUI [1])
ID.4
Item
no other malignancy, except non-melanoma skin cancer, cin, or in-situ cervical cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ID.5
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
ID.6
Item
suitable candidate for treatment with paclitaxel
boolean
C0144576 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
ID.7
Item
previously treated with taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
boolean
C0144576 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
ID.8
Item
if, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
ID.9
Item
if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dl; creatinine levels less than or equal to 2 mg/dl; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
ID.10
Item
patient has an expected survival of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
ID.11
Item
patient or his/her representative has signed an informed consent statement
boolean
C0021430 (UMLS CUI [1])