An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 31-year-old woman developed decreased levels of proteins C and S during to warfarin anticoagulation therapy and dysgeusia during treatment with crizotinib for an occult lung adenocarcinoma.
The woman presented to an emergency department with a painful, and cold and blue left leg with absent distal pulses. Four days prior, she had been diagnosed with a deep vein thrombosis (DVT) which had presented with left leg swelling
and was initiated on simultaneous dalteparin sodium [dalteparin] 200 U/kg, and warfarin at loading doses of 10mg, and 5mg on two occasions [route not stated]. Her INR was 5.78, with a platelet count of 205 [unit not stated]. A CT angiogram confirmed an extensive left leg DVT and a secondary arterial compromise, leading to venous gangrene. A preserved flow in...