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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 study analysing the safety results for the risk of opportunistic infections from various clinical trials (GEMINI 1, GEMINI 2, GEMINI open-label extension study) and post marketing setting (vedolizumab Global safety database) described 14 patients including 6 male and 5 female patients [not all ages and sexes stated], who developed Pneumocystis jiroveci pneumonia, unspecified opportunistic infections, Cytomegalovirus (CMV) infection, pharyngitis, rash, dyspnoea, Clostridium difficile infection or various types of TB infections during treatment with vedolizumab, unspecified steroids, adalimumab, azathioprine, budesonide, infliximab, methylprednisolone, prednisolone or prednisone [not all routes, dosages, indications and outcomes stated]. Out of these patients, two patients...
- Ng SC, et al. Low frequency of opportunistic infections in patients receiving vedolizumab in clinical trials and post-marketing setting. Inflammatory Bowel Diseases 24: 2431-2441, No. 11, Nov 2018. Available from: URL: http://doi.org/10.1093/IBD/IZY153 - Hong Kong