Table 13. Summary of serious adverse events, shown by reasons for which they were considered serious, not shown by study arm.

	Causes death (N=XX)	Life threatening event * (N=XX)	Hospitalisation of prolongation of hospitalisation (N=XX)	Persistent or significant disability/ incapacity ** (N=XX)	Congenital anomaly/birth defect (N=XX)	Important medical event which may jeopardise the patient and/or require intervention (N=XX)
	N Summary statistic	n Summary statistic	N Summary statistic	n Summary statistic	n Summary statistic	n Summary Statistic
Name of event	XX (XX%)	XX (XX%)	XX (XX%)	XX (XX%)	XX (XX%)	XX (XX%)

* Subjects were at immediate risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. ** A substantial disruption of a person's ability to conduct normal life functions. N is the number of all patients; n is the number of patients with a non-missing value. Summary statistic is absolute count (%) for categorical variable(s).