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 died06 (5)3 (2)9 (2)
    Cause of death
    Cardiac arrest01 (1)01 (<1)
    Death related to septic shock01 (1)01 (<1)
    Pulmonary cardiac arrest01 (1)01 (<1)
    Respiratory distress01 (1)01 (<1)
    Respiratory failure001 (1)1 (<1)
    Sepsis01 (1)01 (<1)
    Shortness of breath001 (1)1 (<1)
    Spontaneous bacterial peritonitis001 (1)1 (<1)
    Suspected arrhythmias01 (1)01 (<1)
During the entire 44-wk treatment period
    Total no. subjects who died4 (3)6 (5)4 (3)14 (4)
    Cause of death
    Sepsis1 (1)1 (1)02 (1)
    Advanced metastatic prostate cancer1 (1)001 (<1)
    Cardiac arrest01 (1)01 (<1)
    Death related to septic shock01 (1)01 (<1)
    Diabetic complications1 (1)001 (<1)
    Pulmonary cardiac arrest01 (1)01 (<1)
    Respiratory distress01 (1)01 (<1)
    Respiratory failure001 (1)1 (<1)
    Respiratory failure from asthma001 (1)1 (<1)
    Shortness of breath001 (1)1 (<1)
    Spontaneous bacterial peritonitis001 (1)1 (<1)
    Suspected arrhythmias01 (1)01 (<1)
    Unknown1 (1)001 (<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.