4.5. Evaluation Methods
Tumors
TUMORS, ADVERSE EVENT
All data analyses were performed using a predetermined statistical plan. The full analysis set (FAS) included patients receiving at least one dose of durvalumab, one dose of cisplatin, and one session of CIRT. The population of patients that complied with the guidelines for GCP was defined as the safety analysis set (SAS), and AEs in the SAS were evaluated [All AEs were evaluated using the Common Terminology Criteria for Adverse Events version 5.0 [Regarding efficacy analyses, the OR was the percentage of patients with CR or partial response among the PPS that could be evaluated, as confirmed based on Response Evaluation Criteria in Solid Tumors version 1.1 [