Informed Consent
Item
written (signed) informed consent(s)
boolean
C0021430 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Inoperable incurable | Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer recurrent | Non-small cell lung cancer metastatic
Item
inoperable and incurable, locally advanced, recurrent or metastatic nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0175969 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0278517 (UMLS CUI [3])
C0278987 (UMLS CUI [4])
Chemotherapy | Relapse | Combination Chemotherapy | Combination Chemotherapy Pharmaceutical Preparations Two | Chemotherapy, single agent Patients Elderly | Chemotherapy, single agent Patients poor performance status
Item
relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients)
boolean
C3665472 (UMLS CUI [1])
C0035020 (UMLS CUI [2])
C1521750 (UMLS CUI [3])
C1521750 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0205448 (UMLS CUI [4,3])
C3846440 (UMLS CUI [5,1])
C0030705 (UMLS CUI [5,2])
C0001792 (UMLS CUI [5,3])
C3846440 (UMLS CUI [6,1])
C0030705 (UMLS CUI [6,2])
C1831741 (UMLS CUI [6,3])
Age
Item
age >=18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 to 3
boolean
C1520224 (UMLS CUI [1])
Toxic effect Due to Prior Therapy | Patient Recovered
Item
recovered from the toxic effects of prior therapy
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
Protocol Compliance
Item
able to comply with study and follow-up procedures
boolean
C0525058 (UMLS CUI [1])
Able to take medication Oral
Item
able to take oral medication
boolean
C4075001 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Fertility Contraceptive methods
Item
use of an effective means of contraception (for patients with reproductive potential)
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Granulocyte count
Item
granulocyte count >=1.0 x 10^9/l
boolean
C0857490 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >=75 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin <1.5 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Aspartate aminotransferase increased Due to Secondary malignant neoplasm of liver
Item
sgot (ast) <2 x uln unless elevation is clearly due to liver metastases; then sgot (ast) must be <5 x uln
boolean
C0201899 (UMLS CUI [1])
C0151904 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0494165 (UMLS CUI [2,3])
Creatinine measurement, serum
Item
serum creatinine <=1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Systemic disease Unstable | Communicable Diseases | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Liver diseases | Kidney Diseases | Metabolic Diseases
Item
any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease)
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
HER1 Antagonists Small Molecule Systemic | gefitinib | Iressa | erlotinib | Tarceva | Investigational New Drugs
Item
prior therapy with any systemic her1/egfr small molecule inhibitor, including gefitinib (iressa), erlotinib (tarceva), or other investigational agents in this class
boolean
C2916831 (UMLS CUI [1,1])
C1328819 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C1122962 (UMLS CUI [2])
C0919281 (UMLS CUI [3])
C1135135 (UMLS CUI [4])
C1135136 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
Malignant Neoplasm | Malignant Neoplasm Treated Adequate | Continuance of life Anticipated
Item
history of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of >=90%
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0038952 (UMLS CUI [3,1])
C3840775 (UMLS CUI [3,2])
CNS metastases untreated | Operative Surgical Procedures | Therapeutic radiology procedure | CNS metastases Symptomatic | CNS metastases Unstable
Item
known central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0686377 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0686377 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
Breast Feeding | Pregnancy
Item
nursing mothers or pregnant females
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])