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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
An 18-year-old boy developed respiratory arrest, coma, increased HR, decreased BP, dilated pupils, tonic clonic seizure, prolonged QRS and QTc, absent brainstem and upper limb reflexes, hypotonia and unresponsiveness following toxicity and overdose of amitriptyline [time to reactions onset not stated; not all outcomes stated].
The boy, who had Raynaud's phenomenon, presented to the emergency department after a suspected mixed overdose of oral amitriptyline 6g [amount ingested not stated] and diazepam. His friends found him unresponsive and grunting with empty packets of amitriptyline and diazepam. His initial Glasgow coma score (GCS) was 7. He developed respiratory arrest on the way to hospital. At the emergency department, the GCS was 3, saturations on 15L...