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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 report, a 53-year-old man and a 63-year-old man developed severe disseminated gonococcal infection with polyarticular gout following self-medication with indometacin and colchicine, respectively, for presumed gout [routes, dosages and times to reactions onsets not stated].
Case 1: The 53-year-old man had a history of up to 6 episodes/year of acute gout for 10 years along with hazardous alcohol use. He had not been taking preventative therapy for gout. Four days following unprotected sexual intercourse with a commercial sex worker in Manila, Philippines, he developed left ankle pain and swelling, fevers and chills. He self-medicated himself with indometacin [indomethacin] for presumed gout, and the response was noted. Then, he developed polyarthritis, which included the...