Informed Consent
Item
provision of signed, written and dated consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female, aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Locally Advanced Lung Non-Small Cell Carcinoma TNM clinical staging | Metastatic non-small cell lung cancer TNM clinical staging
Item
histological or cytological confirmation of locally advanced or metastatic nsclc (iiib-iv)
boolean
C5205550 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Gender Breast Feeding Absent | Gender Pregnancy test negative | Childbearing Potential Absent
Item
female patients must not be breast-feeding and have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Platinum Doublet | Selumetinib | Combined Modality Therapy
Item
patients must be eligible to receive treatment with the platinum doublet combination with which selumetinib is being combined and in accordance with the local product information
boolean
C5206469 (UMLS CUI [1])
C2980074 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Prior Chemotherapy Advanced Lung Non-Small Cell Carcinoma | Cancer treatment Systemic Advanced Lung Non-Small Cell Carcinoma
Item
prior chemotherapy or other systemic anti-cancer treatment for advanced nsclc.
boolean
C1514457 (UMLS CUI [1,1])
C5206378 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C5206378 (UMLS CUI [2,3])
Operative Surgical Procedure Recent | Therapeutic radiology procedure Recent | Palliative course of radiotherapy Recent
Item
prior surgery or radiotherapy within 6 months or palliative radiotherapy within 4 weeks of start of study treatment.
boolean
C0543467 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0475092 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent
Item
female patients who are breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
boolean
C0006147 (UMLS CUI [1])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
another primary malignancy within 5 years of starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Systemic disease Severe | Systemic disease Uncontrolled | Bleeding tendency | Kidney Transplantation | Communicable Disease
Item
as judged by the investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1458140 (UMLS CUI [3])
C0022671 (UMLS CUI [4])
C0009450 (UMLS CUI [5])