Type of bleeding	Definition
Major bleeding	Fatal bleeding, clinically overt bleeding associated with a decrease in the haemoglobin level of >2 g/dL (1.24 mmol/L) compared with the pre-bleeding level, clinically overt bleeding leading to transfusion of two or more units of whole blood or packed cells, and symptomatic bleeding in a critical area or organ, such as retroperitoneal, intracranial, intraocular, intra-spinal, intra-articular, pericardial, or intramuscular bleeding with compartment syndrome
CRNM bleeding	Any bleeding event considered as clinically relevant by the IAC that did not meet the criteria of a major bleeding event, e.g. any bleeding event that required medical attention or any bleeding requiring discontinuation of blinded study drug treatment
All other bleeding events	Those events not fulfilling the criteria of major or CRNM bleeding events. In addition, transfusions and the reasons behind them were tracked, and for each bleeding episode, an adjusted decrease in haemoglobin was computed by adding the number of units of packed red blood cells transfused to the decrease in haemoglobin

CRNM, clinically relevant non-major; IAC, independent adjudication committee.