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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
An 80-year-old man developed lumbar discitis and osteomyelitis due to Mycobacterial bovis infections during treatment with BCG for superficial bladder cancer.
The man was admitted to the hospital with a 2 week history of increasing lumbar back pain. His medical history included hypertension, hyperlipidaemia and bladder cancer. For bladder cancer, he had been treated with BCG [Bacillus Calmette-Guerin] instillation chemotherapy [route and dosage not stated]. During the previous 2 years, he had received more than 27 BCG instillation therapies and more than 10 cystoscopies for bladder cancer. The most recent instillation of BCG and cystoscopy was administered 1 month previously. He exhibited malaise, right ring finger pain and low back pain. Physical examination of his back showed...