Table 3.

Treatment-emergent SAEs

0.6 mg/kg (n = 6)0.9 mg/kg (n = 9)1.2 mg/kg (n = 14)Overall (n = 29)
Preferred termn (%)n (%)n (%)n (%)
Dyspneaa1 (16.7)01 (7.1)2 (6.9)
Bile duct stenosis001 (7.1)1 (3.4)
Convulsion01 (11.1)01 (3.4)
Fluid overloada001 (7.1)1 (3.4)
Gait disturbance001 (7.1)1 (3.4)
Pulmonary embolisma1 (16.7)001 (3.4)
Renal failure001 (7.1)1 (3.4)
Renal failure acutea001 (7.1)1 (3.4)
Soft tissue injury001 (7.1)1 (3.4)
Transaminases increased001 (7.1)1 (3.4)
  • aDetermined to be possibly or probably related to study treatment by the investigator.