An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 29-year-old man developed leptospirosis leading to pulmonary haemorrhage syndrome during treatment with prednisolone for lumbar disc prolapse.
The man had travelled to Indonesia for 3 weeks, where he was involved in trekking in the rainforest and swimming in fresh water pools. He received oral prednisolone 25mg daily for 5 days because of suspected lumbar disc prolapse until a few days before departure to Indonesia. In <24 hours following his return from Indonesia, he presented to the emergency room with headache, diarrhoea, chills, fever and myalgia, which lasted for <2 days. He experienced similar symptoms 8 days previously. At first presentation, heart rate was 109/minute, RR was 18/minute, peripheral oxygen saturation 100%, BP was 118/67mm Hg and body temperature was...
- Schonfeld A, et al. Severe pulmonary haemorrhage syndrome in leptospirosis in a returning traveller. Infection 47: 125-128, No. 1, Feb 2019. Available from: URL: http://doi.org/10.1007/s15010-018-1220-7 - Germany