Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural Effusion, Malignant | Malignant pericardial effusion
Item
diagnosis of stage iiib with malignant pleural or pericardial effusion or stage iv (american joint committee on cancer [ajcc]) nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0080032 (UMLS CUI [2])
C0220655 (UMLS CUI [3])
ECOG performance status
Item
ecog performance score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, hepatic, and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
New York Heart Association Classification
Item
new york heart association (nyha) score 1-2
boolean
C1275491 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential Contraceptive methods | Female Sterilization | Male sterilization | Postmenopausal state
Item
women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
C0015787 (UMLS CUI [3])
C0024559 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
Informed Consent | Informed Consent Patient Representatives | Protocol Compliance
Item
the patient or patient's legal representative has the ability to understand the requirements of the trial, has provided written informed consent, and agrees to abide by the trial restrictions and to return for the required assessments.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Subcutaneous Injections Daily Self Administration | Subcutaneous Injections Daily Administration Caregiver
Item
the patient must be able to self administer daily subcutaneous injections or his/her caregiver must be able to administer daily subcutaneous injections.
boolean
C0021499 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0036589 (UMLS CUI [1,3])
C0021499 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C0085537 (UMLS CUI [2,4])
Chemotherapy Non-Small Cell Lung Carcinoma Advanced | Neoadjuvant Chemotherapy Non-Small Cell Lung Carcinoma | Adjuvant Chemotherapy Non-Small Cell Lung Carcinoma
Item
prior chemotherapy for advanced nsclc or the patient has received prior neoadjuvant or adjuvant chemotherapy for nsclc in the year prior to the date of randomization
boolean
C0392920 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
C0085533 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
CNS metastases
Item
patients with central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Systemic disease Excludes Chemotherapy
Item
any systemic disease precluding chemotherapy
boolean
C0442893 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
CORTICOSTEROIDS FOR SYSTEMIC USE Dose chronic
Item
chronic use of systemic corticosteroids in pharmacological doses
boolean
C3653708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
known or history of hiv, hepatitis b virus (hbv) or hepatitis c virus (hcv) infection
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Medical contraindication Paclitaxel | Medical contraindication Carboplatin | Medical contraindication NOV 002 Component
Item
contraindication to treatment with paclitaxel or carboplatin or any of the components of nov-002
boolean
C1301624 (UMLS CUI [1,1])
C0144576 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0079083 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C1831919 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Medical condition Pre-existing Interferes with Study Subject Participation Status | Medical condition Pre-existing Interferes with Protocol Compliance | Substance Use Disorders
Item
any known preexisting medical condition, including substance abuse, that could interfere with the patient's participation in and completion of the protocol
boolean
C3843040 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C0038586 (UMLS CUI [3])
Investigational New Drugs Non-Prescription
Item
have received any investigational drug, defined as a drug for which there is no food and drug administration (fda) approved indication, within the 30 days prior to randomization
boolean
C0013230 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant female or nursing mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])