Table 1.

Patient disposition

Patient dispositionn
Screened38
 Screen failure3
Enrolled35
 Discontinued before first dose1
Dosed patients34
 Discontinued before second dose5
Completed cycle 129
 Discontinuation before cycle 212
  Not eligible for continued treatment5
  Voluntary withdrawal1
  Treatment-emergent AE1
  Disease progression5
Received extended treatment17
 Voluntary withdrawal4
 Treatment-emergent AE2
 Disease progression11
Deaths3 a
  • aTwo patients died due to progressive disease, and 1 patient died due to an infection, unrelated to BI-505.