Colorectal cancer metastatic unresectable | Disease Progression | Chemotherapy Regimen Quantity | Fluorouracil
Item
pathologically confirmed unresectable mcrc which has progressed on at least one prior 5-fluorouracil (5fu)-containing chemotherapy regimen
boolean
C0948380 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0016360 (UMLS CUI [4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of >/= 3 months as documented by the investigator
boolean
C0023671 (UMLS CUI [1])
Body Weight
Item
baseline actual body weight </=160 kg
boolean
C0005910 (UMLS CUI [1])
Informed Consent
Item
competent to comprehend, sign, and date a written iec/irb approved informed consent form before any study-specific procedures are performed
boolean
C0021430 (UMLS CUI [1])
Therapeutic radiology procedure
Item
treatment with radiotherapy </= 14 days before enrollment. patients must have recovered from all radiotherapy-related toxicities
boolean
C1522449 (UMLS CUI [1])
CNS metastases
Item
known presence of central nervous systems (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of
Item
any prior malignancy (except for non-melanomatous skin cancer or in situ cervical cancer) other than the study disease, unless treated with curative intent with no evidence of disease </= 2 years before enrollment
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Lung Diseases, Interstitial | Pneumonitis | Pulmonary Fibrosis | Interstitial Lung Disease Chest CT
Item
history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest ct scan
boolean
C0206062 (UMLS CUI [1])
C3714636 (UMLS CUI [2])
C0034069 (UMLS CUI [3])
C0206062 (UMLS CUI [4,1])
C0202823 (UMLS CUI [4,2])
Inflammatory Bowel Diseases | Intestinal Diseases Causing Chronic diarrhea | Intestinal Diseases CTCAE Grades
Item
active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > ctc grade 2 [ctcae version 3])
boolean
C0021390 (UMLS CUI [1])
C0021831 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0401151 (UMLS CUI [2,3])
C0021831 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure | Cardiac Arrhythmia Serious Uncontrolled
Item
clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) </= 1 year before enrollment
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0205318 (UMLS CUI [5,3])
UGT1A1*28 Allele Genetic Polymorphism | Gilbert Disease
Item
ugt1a1*28 ta7/7, ta7/8, ta8/8 genetic polymorphisms; gilbert's disease
boolean
C2825127 (UMLS CUI [1,1])
C0032529 (UMLS CUI [1,2])
C0017551 (UMLS CUI [2])
CYP3A4 Inhibitors | CYP3A4 Inducer
Item
treatment with cyp3a4 enzyme inhibiting or inducing medications </= 2 weeks before enrollment
boolean
C3850053 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
Anti-egfr monoclonal antibody therapy | cetuximab | Small Molecule EGFR inhibitor | gefitinib | erlotinib | lapatinib
Item
prior anti-egfr antibody therapy (eg, cetuximab) or treatment with small molecule egfr inhibitors (eg, gefitinib, erlotinib, lapatinib)
boolean
C4316122 (UMLS CUI [1])
C0995188 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C1443775 (UMLS CUI [3,2])
C1122962 (UMLS CUI [4])
C1135135 (UMLS CUI [5])
C1506770 (UMLS CUI [6])
Systemic Chemotherapy | Hormone Therapy | Immunotherapy | Proteins Investigational | Antibodies Investigational | Proteins Approved | Antibodies Approved | Bevacizumab
Item
systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (eg, bevacizumab) </= 30 days before enrollment
boolean
C1883256 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0033684 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
C3495458 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C0033684 (UMLS CUI [6,1])
C0205540 (UMLS CUI [6,2])
C3495458 (UMLS CUI [7,1])
C0205540 (UMLS CUI [7,2])
C0796392 (UMLS CUI [8])
Immunosuppressive Agents | Methotrexate | Cyclosporine | Adrenal Cortex Hormones allowed
Item
subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine), however corticosteroids are allowed
boolean
C0021081 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
C0010592 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Major surgery | Minor Surgical Procedures | Exception Catheter placement
Item
major surgery < 28 days prior to enrollment or minor surgery (excluding catheter placement) < 14 days before enrollment
boolean
C0679637 (UMLS CUI [1])
C0038904 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0883301 (UMLS CUI [3,2])