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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
In a retrospective chart review study of 29 patients conducted at a tertiary care hospital in India, received posaconazole for the COVID-19–associated mucormycosis (CAM) during 1 March 2021 and 31 May 2021, two patients [ages and sexes not stated] were described, who developed nausea, vomiting and loss of appetite (n=1), or QT-interval prolongation (n=1) during treatment with posaconazole for CAM.
Both the patients were diagnosed with CAM. They started receiving oral delayed release tablet of posaconazole 300mg once a day after a loading dose of 300mg posaconazole delayed release tablet twice a day. After therapy, the first patient developed nausea, vomiting and loss of appetite as adverse drug reaction, whereas, the second patient developed QT-interval prolongation without symptoms, as adverse drug reaction [duration of treatments to reactions onset not stated].
Subsequently, both the patients' discontinued the treatment with posaconazole [outcomes not stated].