Age
Item
man or woman at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Colorectal cancer metastatic
Item
diagnosis of metastatic colorectal cancer
boolean
C0948380 (UMLS CUI [1])
Measurable lesion Linear Quantity | Measurable lesion Size
Item
at least 1 uni-dimensionally measurable lesion of at least 20 mm per modified recist
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0449453 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Primary tumor Paraffin Embedded Tissue Available | Neoplasm Metastasis Paraffin Embedded Tissue Available | Exclusion Criteria
Item
paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyse exclusion criteria:
boolean
C0677930 (UMLS CUI [1,1])
C1519524 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C1519524 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
C0680251 (UMLS CUI [3])
CNS metastases
Item
history or known presence of central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Primary malignant neoplasm | Curative treatment Carcinoma in situ of uterine cervix | Skin carcinoma Resected Curative | Curative treatment Solid tumour Primary
Item
history of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization
boolean
C1306459 (UMLS CUI [1])
C1273390 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C0699893 (UMLS CUI [3,1])
C1521996 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
C1273390 (UMLS CUI [4,1])
C0280100 (UMLS CUI [4,2])
C0205225 (UMLS CUI [4,3])
Chemotherapy Colorectal cancer metastatic | Systemic therapy Colorectal cancer metastatic | Adjuvant Chemotherapy Fluoropyrimidine Based | Fluoropyrimidine Radiosensitization Related
Item
prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy administered solely for the purpose of radiosensitization
boolean
C0392920 (UMLS CUI [1,1])
C0948380 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0948380 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3,1])
C0596581 (UMLS CUI [3,2])
C1705938 (UMLS CUI [3,3])
C0596581 (UMLS CUI [4,1])
C0279024 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
oxaliplatin
Item
prior oxaliplatin therapy
boolean
C0069717 (UMLS CUI [1])
EGFR Antibody | cetuximab | Epidermal growth factor receptor inhibitor Small Molecule | erlotinib
Item
prior anti-epidermal growth factor receptor (egfr) antibody therapy (eg, cetuximab) or treatment with small molecule egfr inhibitors (eg, erlotinib)
boolean
C4055105 (UMLS CUI [1])
C0995188 (UMLS CUI [2])
C1443775 (UMLS CUI [3,1])
C1328819 (UMLS CUI [3,2])
C1135135 (UMLS CUI [4])
Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure | Cardiac Arrhythmia Uncontrolled Serious | Lung Diseases, Interstitial | Pneumonia | Pulmonary Fibrosis | Interstitial Lung Disease Evidence Chest CT
Item
clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year prior to randomization history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (ct) scan
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0205404 (UMLS CUI [5,3])
C0206062 (UMLS CUI [6])
C0032285 (UMLS CUI [7])
C0034069 (UMLS CUI [8])
C0206062 (UMLS CUI [9,1])
C0332120 (UMLS CUI [9,2])
C0202823 (UMLS CUI [9,3])
Inflammatory Bowel Disease | Intestinal Disease Causing Chronic diarrhea CTCAE Grades
Item
active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > common terminology criteria (ctc) grade 2 [ctcae version 3.0])
boolean
C0021390 (UMLS CUI [1])
C0021831 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0401151 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])
Peripheral sensory neuropathy | Impairment Functional
Item
peripheral sensory neuropathy with functional impairment
boolean
C0151313 (UMLS CUI [1])
C0221099 (UMLS CUI [2,1])
C0205245 (UMLS CUI [2,2])