Abstract
Objective
To retrospectively analyze the clinical safety and adverse drug reactions (ADRs) of sintilimab, to evaluate risk factors for ADR occurrence, and to develop a predictive model to support individualized treatment strategies.Materials and methods
Medical records of patients who received sintilimab treatment in the period January 2021 to December 2022 were examined. Clinical data, including demographic characteristics, medication details, and ADRs were recorded and evaluated using univariate and multivariate logistic regression analyses to identify independent risk factors for sintilimab-induced ADRs. Variables such as gender, age, comorbidities, and treatment regimens were included. Receiver operating characteristic (ROC) curve analysis was performed to assess the predictive accuracy of individual and combined risk factors, enabling the safety profile of sintilimab to be established.Results
A total of 337 cases were retrieved of which 208 (61.72%) referred to patients who experienced ADRs. Multivariate analysis identified combination drug therapy (OR = 25.670, 95% CI: 11.319 - 58.218, p Conclusion
Combination therapy and pretreatment baseline assessment are independent risk factors for ADRs occurring during therapy with sintilimab. The combined predictive model derived shows high accuracy and may have value in predicting treatment risks and managing personalized medication.