TABLE 5

Treatment-emergent adverse eventsa

CharacteristicNeonate (<4 wk in CA)Infant (4 to <12 wk in CA)Total
<32 wk in GA≥32 to ≤44 weeks GA<32 wk in GA; group 5≥32 to ≤44 wk in GA; group 6
<14 days in CA; group 1≥14 days in CA; group 2<14 days in CA; group 3≥14 days in CA; group 4
n899871152
Subjects with adverse events, n (%)3 (37.5)7 (77.8)1 (11.1)3 (37.5)4 (57.1)3 (27.3)21 (40.4)
Most common adverse events (≥2% of subjects), n (%)
    Neonatal anemia03 (33.3)001 (14.3)04 (7.7)
    Hypoalbuminemia03 (33.3)00003 (5.8)
    Fungal infection01 (11.1)001 (14.3)02 (3.8)
    Nosocomial infection1 (12.5)1 (11.1)00002 (3.8)
    Hyperglycemia1 (12.5)1 (11.1)00002 (3.8)
    Peripheral edema01 (11.1)01 (12.5)002 (3.8)
    Diaper dermatitis00001 (14.3)1 (9.1)2 (3.8)
    Patent ductus arteriosus2 (25)000002 (3.8)
  • a Percentages were calculated with the number of subjects in each group as denominator. Incidence is based on number of subjects, not number of events.