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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, four male patients were described, aged 66-77 years, the patients developed granulomatous prostatitis, seminal vesiculitis, anejaculation and dysuria (first patient), mycotic aneurysm (second patient), fever, weight loss and malaise (third patient), and pneumonitis and hepatitis following administration with BCG for bladder cancer (fourth patient). The fourth patient additionally developed hepatotoxicity during treatment with ethambutol, isoniazid and rifampicin [not all routes, dosages and duration of treatments to reactions onsets stated].
Patient 1: A 66-year-old man received intravesicular BCG for bladder cancer. He underwent transurethral resection (TUR) once. After 47 days of TUR, he received first BCG. He received total six instillation of BCG. After...
- Bilsen MP, et al. A novel view on the pathogenesis of complications after intravesical BCG for bladder cancer. International Journal of Infectious Diseases 72: 63-68, Jul 2018. Available from: URL: http://doi.org/10.1016/j.ijid.2018.05.006 - Netherlands