Adenocarcinoma of colon | Adenocarcinoma of rectum | Neoplasm Metastasis TNM clinical staging unresectable
Item
histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (m1) disease
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C1519810 (UMLS CUI [3,3])
Measurable lesion Linear Quantity | Measurable lesion Size
Item
patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified response evaluation criteria in solid tumors (recist) guidelines
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Tumor status Wild Type KRAS gene | Test Method Validation
Item
wild-type kras tumor status confirmed by an amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
boolean
C0475752 (UMLS CUI [1,1])
C1883559 (UMLS CUI [1,2])
C1537502 (UMLS CUI [1,3])
C0871511 (UMLS CUI [2,1])
C1519941 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
men or women 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Metabolic function normal | Coagulation function analysis
Item
adequate hematologic, renal, hepatic, metabolic, and coagulation function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0438212 (UMLS CUI [4])
C3516400 (UMLS CUI [5])
CNS metastases
Item
history of prior or concurrent central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Prior Chemotherapy Colorectal Carcinoma metastatic | Cancer treatment Systemic Colorectal cancer metastatic
Item
prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
boolean
C1514457 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0948380 (UMLS CUI [2,3])
Heart Disease
Item
clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Sensory neuropathy
Item
clinically significant peripheral sensory neuropathy
boolean
C0151313 (UMLS CUI [1])
Inflammatory Bowel Disease
Item
active inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
Peptic Ulcer | Peptic Ulcer Uncontrolled
Item
recent gastroduodenal ulcer to be active or uncontrolled
boolean
C0030920 (UMLS CUI [1])
C0030920 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Lung Diseases, Interstitial
Item
history of interstitial lung disease
boolean
C0206062 (UMLS CUI [1])
Pulmonary Embolism | Deep Vein Thrombosis | Disorder of vein
Item
recent pulmonary embolism, deep vein thrombosis, or other significant venous event
boolean
C0034065 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0235522 (UMLS CUI [3])
Bleeding tendency Pre-existing | Blood Coagulation Disorders Pre-existing | Exception Anticoagulation Therapy Well controlled
Item
pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
boolean
C1458140 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0003281 (UMLS CUI [3,2])
C3853142 (UMLS CUI [3,3])
Major surgery | Incisional biopsy | Traumatic injury | Major surgery Previous Recovery Lacking
Item
recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0679637 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C2004454 (UMLS CUI [4,3])
C0332268 (UMLS CUI [4,4])