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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 59-year-old man developed massive haemoptysis due to Bacillus cereus necrotising pneumonia while receiving immunosuppressive therapy with carboplatin and paclitaxel for oesophageal adenocarcinoma [duration of treatments to reactions onsets not stated].
The man, who had stage IIIa distal oesophageal adenocarcinoma, started receiving neoadjuvant radiation and chemotherapy with paclitaxel and carboplatin [dosages and routes not stated]. Subsequently, he presented to an emergency department (ED) with sudden onset of haemoptysis (approximately 200mL). He rapidly developed epigastric pain, nausea and a history of retching coinciding with the haemoptysis. His initial vital signs were as follows: temperature 39.2C, BP 90/65mm Hg, heart rate (HR) 147 bpm, 18 respirations/min and...