Table 1 Definition of serious adverse events

Any adverse event or adverse reaction that:

 a. Results in death

 b. Is life threatening

 c. Requires hospitalisation or prolongation of existing hospitalisation

 d. Results in persistent or significant disability or incapacity

 e. Consists of a congenital anomaly or birth defect

 f. Is otherwise considered medically significant by the investigator

 g. Is important but is not immediately life threatening or does not result in death or hospitalization, but may jeopardise the subject or may require intervention to prevent one of the other outcomes listed in the definitions above