Factors associated with fatal coronavirus disease 2019 infections among cancer patients in the US FDA Adverse Event Reporting System database

Aim: To explore factors affecting coronavirus disease 2019 (COVID-19) mortality among cancer patients based on a pharmacovigilance database. Methods: US FDA Adverse Event Reporting System (FAERS) quarterly data extract files were reviewed for quarters two, three and four of 2020 (i.e., April to December). Patients with an indication related to malignancy and a reported COVID-related reaction were selected. Multivariate logistic regression analysis for factors associated with a fatal outcome was conducted. Results: A total of 2708 patients were included. The following factors were associated with fatal COVID-19 infection: older age (odds ratio [OR]: 1.03; 95% CI: 1.01-1.04), male sex (OR: 1.43; 95% CI: 1.07-1.91), non-US report source (OR: 2.46; 95% CI: 1.93-3.13), hematological malignancy (OR: 1.62; 95% CI: 1.28-2.07), potentially immunosuppressive treatment (OR: 1.83; 95% CI: 1.30-2.58) and diagnosis in quarter two versus quarter four (OR: 1.62; 95% CI: 1.27-2.07). Conclusion: Within FAERS reports, cancer patients who are older, males and receiving immunosuppressive treatment and those with hematological malignancies were at a higher risk of death because of COVID-19 infection. Lay abstract In this study, individuals with a diagnosis of cancer who were older and males and those receiving immunosuppressive treatment seemed to be at a higher risk of a fatal outcome of coronavirus disease 2019 infection.