Spectrum of Adverse Effects Associated with Immunotherapy and Biologicals in Patients with Malignancy

A BSTRACT Background: This study aimed to determine the toxicity profile of cancer drugs in the Indian population and to evaluate their usage patterns among Indian patients. Materials and Methods: A prospective and observational study was conducted in the department of medicine from April 2023 to March 2024. Patients aged ≥18 years with cancer receiving immunotherapy or biological therapy were enrolled, excluding pregnant/postpartum women and those with central nervous system-related causes of weakness. A total of 152 patients were included based on the sample size estimation. Demographic, clinical, laboratory, and imaging evaluations were performed. Adverse events (AEs) were graded using the Common Terminology Criteria for Adverse Events v5.0. Statistical analysis was performed using Fisher’s exact test, with P < 0.05 considered statistically significant.