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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
* Drug overdose
A 50‐year‐old woman developed hepatotoxicity, hepatic encephalopathy and mania secondary to drug intoxication following an intentional overdose of paracetamol with an unclear suicidal intent [not all times to reactions onset stated].
The woman was admitted due to severe depressive episode with psychotic features and treated with electroconvulsive therapy (ECT). After receiving 19 sessions of ECT, on day 106 of admission, she took an intentional overdose of paracetamol [acetaminophen] 16g with unclear suicidal intent. Additionally, she was receiving treatment with various medications concomitantly. Subsequently, she received activated charcoal and was shifted to the emergency department. During admission, laboratory investigation showed normal Glasgow Coma Scale...