Appendix A.2. Exclusion Criteria
NSCLC, death, myocardial infarction, autoimmune disorder, cardiovascular diseases, cancer, idiopathic pulmonary fibrosis, hypothyroidism, prostate cancer, malignant disease
HYPOTHYROIDISM, BRAIN METASTASIS, DUCTAL CARCINOMA IN SITU, METASTASIS, MYOCARDIAL INFARCTION, SQUAMOUS CELL SKIN CANCER, AUTOIMMUNE DISORDER, CARDIOVASCULAR DISEASES, CANCER, TYPE 1 DIABETES, HYPERSENSITIVITY, NSCLC, CARCINOMA IN SITU, IDIOPATHIC PULMONARY FIBROSIS, HEART, PROSTATE CANCER, MALIGNANT DISEASE
Subjects were not included in the study if any of the following exclusion criteria were met:Active central nervous system (CNS) metastasis
Patients with a history of pretreated, asymptomatic CNS metastasis or patients with asymptomatic brain metastasis could be registered.Presence of an active double cancer other than NSCLC within five years prior to enrollment, except malignant disease with negligible risk of metastasis or death and treated with curative intent such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or ductal carcinoma in situ treated with curative intent.
If there were a history of a malignant disease other than NSCLC, the patient could be registered if the diagnosis of the malignant disease exceeded five years based on the enrollment and treatment was completedPregnant and lactating women
A woman of childbearing age: Very effective contraception should be used during the administration of atezolizumab and for at least five months after the last administration.Significant cardiovascular diseases such as New York Heart Association (NYHA) class II or higher or myocardial infarction within three months prior to enrollmentA patient with an active autoimmune disorder or a history of a chronic or recurrent autoimmune disorder
A patient with a history of autoimmune-mediated hypothyroidism when administering stable doses of thyroid hormone replacement may have been eligible for registration in this studyPatients with type 1 diabetes controlled by a stable insulin dose could be registeredUncontrolled idiopathic pulmonary fibrosis or drug-induced pneumonitisAdministration of systemic corticosteroids or other systemic immunosuppressive drugs (prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within two weeks prior to enrollment
Inhaled corticosteroids, megestrol acetate, and premedication up to three days were acceptable.Hypersensitivity to atezolizumab and its component