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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
Two boys, aged 17 and 15 years respectively, developed myocarditis following administration of clozapine. The 15-year-old boy additionally developed vomiting and diarrhoea secondary to clozapine.
Patient A: A 17-year-old boy was diagnosed with treatment-refractory paranoid schizophrenia and had a history of depression, cannabis abuse and antisocial behaviour. His inpatient withdrawal treatment of cannabis and therapy with olanzapine and haloperidol in a sufficient dosage for an adequate duration did not show sufficient benefit in his productive symptoms. Subsequently, he started receiving therapy with clozapine 12.5mg for two days [route not stated]. The dose of clozapine was further titrated to 25mg daily along with weekly blood tests and daily controls of vital signs....