Table 5.

Incidence and causes of mortality

Cause of Death	QW (n = 108), n (%)	Q2W (n = 107), n (%)	Q4W (n = 215), n (%)	Total (n = 430), n (%)
Total no. of subjects who died	4 (4)	3 (3)	9 (4)	16 (4)
Pulmonary edema	1 (1)	0	0	1 (<1)
Cardiac arrest	0	0	1 (<1)	1 (<1)
Cardiopulmonary arrest; etiology unknown	0	0	1 (<1)	1 (<1)
Cardiorespiratory arrest	0	1 (1)	0	1 (<1)
Intracerebral hemorrhage	0	0	1 (<1)	1 (<1)
Liver complications	1 (1)	0	0	1 (<1)
Myocardial infarction	0	0	1 (<1)	1 (<1)
Pneumonia	0	1 (1)	0	1 (<1)
Pulmonary edema	0	0	1 (<1)	1 (<1)
Respiratory failure	0	0	1 (<1)	1 (<1)
Ruptured colon	0	0	1 (<1)	1 (<1)
Severe calcific atherosclerotic heart disease with cardiomegaly	0	0	1 (<1)	1 (<1)
Severe sepsis syndrome	0	0	1 (<1)	1 (<1)
Sudden cardiac death	2 (2)	0	0	2 (<1)
Urosepsis	0	1 (1)	0	1 (<1)

Percentages were calculated with the number of subjects in each group as denominator. The serious adverse events that occurred within 30 days of the last exposure date of study drug and resulted in death were included.