Table 6.

Incidence and causes of mortality

	TIW(n = 123)[n (%)]	QW(n = 125)[n (%)]	Q2W(n = 125)[n (%)]	Total(n = 373)[n (%)]
During first 22 wk of treatment
Total no. subjects who died	0	6 (5)	3 (2)	9 (2)
Cause of death
Cardiac arrest	0	1 (1)	0	1 (<1)
Death related to septic shock	0	1 (1)	0	1 (<1)
Pulmonary cardiac arrest	0	1 (1)	0	1 (<1)
Respiratory distress	0	1 (1)	0	1 (<1)
Respiratory failure	0	0	1 (1)	1 (<1)
Sepsis	0	1 (1)	0	1 (<1)
Shortness of breath	0	0	1 (1)	1 (<1)
Spontaneous bacterial peritonitis	0	0	1 (1)	1 (<1)
Suspected arrhythmias	0	1 (1)	0	1 (<1)
During the entire 44-wk treatment period
Total no. subjects who died	4 (3)	6 (5)	4 (3)	14 (4)
Cause of death
Sepsis	1 (1)	1 (1)	0	2 (1)
Advanced metastatic prostate cancer	1 (1)	0	0	1 (<1)
Cardiac arrest	0	1 (1)	0	1 (<1)
Death related to septic shock	0	1 (1)	0	1 (<1)
Diabetic complications	1 (1)	0	0	1 (<1)
Pulmonary cardiac arrest	0	1 (1)	0	1 (<1)
Respiratory distress	0	1 (1)	0	1 (<1)
Respiratory failure	0	0	1 (1)	1 (<1)
Respiratory failure from asthma	0	0	1 (1)	1 (<1)
Shortness of breath	0	0	1 (1)	1 (<1)
Spontaneous bacterial peritonitis	0	0	1 (1)	1 (<1)
Suspected arrhythmias	0	1 (1)	0	1 (<1)
Unknown	1 (1)	0	0	1 (<1)

Percentages calculated with the number of subjects in each group as denominator. SAEs resulting in death within 30 days of the last dose were included.

n, number; Q2W, every 2 wk; QW, once weekly; TIW, three times weekly.