Characterisation of seriousness and outcome of adverse drug reactions in patients received cancer chemotherapy drugs – A prospective observational study

Abstract

Background: Cancer chemotherapeutic drugs are commonly associated with serious adverse effect which contributes to increase in the duration of hospitalisation and economic burden. Aim: The aim of this study was to characterise the seriousness and outcome of adverse drug reactions (ADRs) produced by chemotherapy drugs in cancer patients. Materials and Methods: Patient's demographic characteristics and ADRs due to chemotherapeutic drugs were documented inpatient case report form. Frequencies of the seriousness of the ADRs, its outcome and preventability were studied using descriptive statistics. Proportion of life-threatening ADRs and ADRs linked to increase in duration of hospitalisation were studied. Factors associated with serious ADRs and patient characteristics were studied using calculation of odds ratio (OR) at 95% confidence interval (P < 0.5). Results: A total of 412 ADRs were noted in selected 120 patients received chemotherapy drugs. Majority of ADRs (61%) were linked to increase in duration of hospital admission. Some ADRs (12%) were noted as life-threatening to the patients. OR 1.58 was found on the association between patient age group and serious ADRs (P = 0.02). Association of preventability of ADRs and serious ADRs shows OR of 3.65 (P = 0.0001). Common serious ADRs were noted as anaemia, neutropenia, fever, thrombocytopenia, diarrhoea, mucositis and nausea and vomiting. Conclusion: The incidence of serious ADRs due to chemotherapy drugs amongst cancer patients is high. Studies on the nature of seriousness of ADRs, outcome and its triggering factors may help to prevent them. Early identification of serious ADRs may support to reduce hospital stay and economic burden.