Objectives: This study focuses on the severity of the adverse effects induced by monoclonal antibodies in Indian population. This study is performed in a multispecialty hospital and adverse effects were monitored in the study population. Therefore, the main objective of the study was active surveillance of adverse effects induced by monoclonal antibodies.
Methodology: A cohort study was conducted in 120 patients with breast and gynaecological cancer for a period of 6 months in a multispecialty hospital.
Result: Among 120 patients Breast cancer was the most prevalent followed by cervical cancer. Adverse effects were seen in all age groups, most adverse effects were reported with Trastuzumab (37.50%) and Bevacizumab (26.78%). Monoclonal antibodies were well tolerated by the patients with minimum adverse effects which are manageable with supportive therapy, the most prevalent adverse effect was anaemia.
Conclusion: By assessing Adverse effects using Naranjo scale, most of them were found to be possible (32%) and probable (67%). In WHO scale, the most of the adverse effects were also follow under category of possible (38.14%) and probable (61.20%). Of all adverse effects no severe adverse effects were seen in the patients, i.e. monoclonal antibodies were well tolerated by the patients.
Key words: Naranjo Scale, WHO Scale, Monoclonal Antibodies, Breast cancer, Gynaecological cancers