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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 55-year-old man and a 62-year-old woman developed ligament avulsion and tendon (hamstring) avulsion respectively following treatment with ciprofloxacin [not all dosages, routes and outcomes stated].
A 55-year-old man presented with a major complaint of right lateral thumb pain 1 week following a forceful extension and adduction incident. He reported a sudden onset of pain, which was rated as 6/10 by him. There was no bruising of the thumb after the incident. His pain relieved after treatment with an over-the-counter thumb splint. He also reported weakness while holding things without numbness or tingling of the thumb. Six weeks prior to presentation, he had developed gastroenteritis after travelling, and he was prescribed a 7-day course of oral...