Table 5.

Incidence and causes of mortality

Cause of DeathQW (n = 108), n (%)Q2W (n = 107), n (%)Q4W (n = 215), n (%)Total (n = 430), n (%)
Total no. of subjects who died4 (4)3 (3)9 (4)16 (4)
Pulmonary edema1 (1)001 (<1)
Cardiac arrest001 (<1)1 (<1)
Cardiopulmonary arrest; etiology unknown001 (<1)1 (<1)
Cardiorespiratory arrest01 (1)01 (<1)
Intracerebral hemorrhage001 (<1)1 (<1)
Liver complications1 (1)001 (<1)
Myocardial infarction001 (<1)1 (<1)
Pneumonia01 (1)01 (<1)
Pulmonary edema001 (<1)1 (<1)
Respiratory failure001 (<1)1 (<1)
Ruptured colon001 (<1)1 (<1)
Severe calcific atherosclerotic heart disease with cardiomegaly001 (<1)1 (<1)
Severe sepsis syndrome001 (<1)1 (<1)
Sudden cardiac death2 (2)002 (<1)
Urosepsis01 (1)01 (<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.