Adverse drug reaction profile of cisplatin-based chemotherapy regimen in a tertiary care hospital in India

M. B. Sasmi


Background: This study was undertaken to analyze the pattern of occurrence of adverse drug reaction (ADR) to cisplatin-based chemotherapy regimen in an oncology ward of a tertiary care hospital.

Methods: Cancer patients who received cisplatin-based chemotherapy were monitored for ADRs. The collected reports were analyzed for demographic and drug details; causality, preventability, and severity of ADRs. Causality assessed by the WHO Causality Assessment Scale and Naranjo’s Algorithm. Preventability and severity assessed by Schumock–Thornton scale and modified Hartwig–Siegel scale, respectively.

Results: Among 138 patients, 125 developed adverse reactions to cisplatin-based chemotherapy. The results observed were alopecia, nausea, vomiting, renal toxicity, peripheral neuropathy, electrolyte imbalance, etc. The WHO Assessment Scale showed 95% possible and 5% probable reactions. Whereas Naranjo’s Algorithm showed 83% probable and 17% possible reactions. Most of the reactions belonged to the category of “not preventable.” Reactions such as nausea and vomiting belonged to the category of “definitively preventable.” Modified Hartwig–Siegel scale showed most of the reactions were of mild Level 1 category.

Conclusions: Cisplatin-based regimen has high potential to cause adverse effects. Most of the reactions were mild in nature, but not preventable. The common adverse effects, such as nausea and vomiting, were preventable.


Causality, Chemotherapy, Cisplatin, Pharmacovigilance

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