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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 71-year-old man developed opioid toxicity during treatment with morphine for left-sided chest pain. Additionally, he developed abdominal pain and haemodynamic instability secondary to increase in bleeding from a ruptured spleen due to anti-coagulated state during treatment with aspirin, clopidogrel and enoxaparin sodium for suspected pulmonary embolism (PE) or acute coronary syndrome [dosages not stated; not all routes stated; durations of treatments to reactions onsets not clearly stated].
The man was referred for urgent colonoscopy due to a suspected sigmoid diverticulosis and sigmoid tumour on a CT scan of kidney ureter bladder. He had a medical history of ischaemic heart disease, renal calculi, rheumatoid arthritis, hypertension and glaucoma. He had also undergone...