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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 37-year-old year woman developed psychotic symptoms and mood symptoms during treatment with cabergoline, and a 29-year-old woman developed psychotic symptoms and mood symptoms secondary to cabergoline, and hypomania due to escitalopram [routes not stated].
The 37-year-old woman had galactorrhoea and menstrual irregularities. She was diagnosed with pituitary prolactinomas. She was administered cabergoline 0.25mg two times a week. Her condition improved. After 8 months of treatment with cabergoline, she developed symptoms like insomnia, persistent sadness, anhedonia, reduced personal hygiene without any probable stressors, decreased appetite, reduced interaction and low energy. She also developed auditory hallucinations and delusions during which, she suspected her husband was...