2.4. Methods
Tumors
ADVERSE EVENT, ADVERSE EVENTS, EVENT, TUMORS, ADVERSE EVENT
The safety and effectiveness analyses were performed with all included patients who received at least one dose of nimotuzumab. The main variable was the proportion of patients with serious adverse events related to the administration of nimotuzumab (very probable, probable, and possible), and the corresponding 95% confidence interval was calculated. The frequency of patients with each adverse event was calculated, and the frequency distributions of each type of reported event. Severity and causality were determined by using the Common Terminology Criteria for Adverse Events (CTCAE, version 4.0).The effectiveness analysis was performed independently for each stratum: locally advanced, metastatic, or recurrent patients, and overall survival (OS) and progression-free survival (PFS) were determined. The clinical response was evaluated as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.