Statistical analysis
Cancer
ONCOLOGY, ADVERSE EVENT, ADVERSE EVENT, CANCER
SAS software version 9.4 (SAS Institute Japan Ltd.) was used for statistical analyses. The following efficacy analyses were performed on the full analysis set (FAS) that included all the enrolled participants except for those with screening failure, no administration of the study drug, or no efficacy data after starting study treatment. Safety assessments were performed in the safety population, which included all the participants who received the investigational drug and provided any safety data. Adverse events were coded according to the Medical Dictionary for Regulatory Activities, version 25.0. Severity was defined in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ver. 5.0 (Japanese translation: Japan Clinical Oncology Group [JCOG] edition [CTCAE v5.0-JCOG]).Further details on the Methods can be found in the full protocol provided in the Additional file 