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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, a 25-year-old man developed acute psychotic schizophrenia and a 28-year-old woman developed acute psychosis during treatment with cycloserine for multi-drug resistance tuberculosis [route not stated].
Case 1: A 25-year-old man, who had pulmonary multi-drug resistance tuberculosis, started receiving anti-multi-drug resistance tuberculosis (anti-MDR-TB) therapy with cycloserine 750mg along with kanamycin, levofloxacin, ethionamide, ethambutol, pyrazinamide and pyridoxine on 22 March 2014. He had a history of treatment failure [specific drugs not stated] and loss to follow-up. Twenty eight days after anti-TB treatment, he came to hospital due to crying, agitation and he kept moving around to do prays. Then, he was hospitalised in a psychiatric ward. His eye...