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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 65-year-old woman and a 76-year-old man developed Cryptococcal organising pneumonia during treatment with prednisolone and methotrexate for neurosarcoidosis and rheumatoid arthritis, respectively [not all route stated].
Patient 1: The woman, who was diagnosed with neurosarcoidosis, started receiving oral prednisolone 45 mg/day. Four months later, methotrexate 8 mg/week was added to her regimen. A month later, she developed productive cough and fever. A chest CT scan showed right pleural effusion and an abnormal shadow in the upper lobe of the right lung. She received treatment with levofloxacin, but her abnormal chest shadow and symptoms did not improve. She presented to another hospital for further investigation and treatment. On day 1 of presentation, she started receiving...
- Chikumoto A, et al. Cryptococcosis as a cause of organizing pneumonia. Respiratory Medicine Case Reports 27: 2019. Available from: URL: http://doi.org/10.1016/j.rmcr.2019.100851 - Japan