Table 4.
Frequently Occurring (≥5 Participants) Adverse Events
| GA <32 Weeks |
GA ≥32 Weeks |
Total | |||
|---|---|---|---|---|---|
| PNA <2 Weeks, No. (%) | PNA ≥2 Weeks, No. (%) | PNA <2 Weeks, No. (%) | PNA ≥2 Weeks, No (%) | ||
| No. | 39 | 103 | 31 | 27 | 200 |
| AST increaseda | 0 (0) | 3 (3) | 0 (0) | 2 (7) | 5 (3) |
| Atelectasis | 2 (5) | 0 (0) | 0 (0) | 3 (11) | 5 (3) |
| Conjugated bilirubin increaseda | 5 (13) | 3 (3) | 0 (0) | 1 (4) | 9 (5) |
| Hyperglycemiaa | 2 (5) | 2 (2) | 1 (3) | 0 (0) | 5 (3) |
| Hypoglycemiaa | 3 (8) | 2 (2) | 0 (0) | 0 (0) | 5 (3) |
| Hypokalemiaa | 2 (5) | 6 (6) | 0 (0) | 1 (4) | 9 (5) |
| Hypotensiona | 1 (3) | 5 (5) | 0 (0) | 0 (0) | 6 (3) |
| Patent ductus arteriosus | 4 (10) | 1 (1) | 0 (0) | 1 (4) | 6 (3) |
| Retinopathy of prematurity | 0 (0) | 5 (5) | 0 (0) | 0 (0) | 5 (3) |
| Sepsis | 5 (13) | 5 (5) | 1 (3) | 1 (4) | 12 (6) |
| Seizures | 4 (10) | 3 (3) | 1 (3) | 2 (7) | 10 (5) |
| Vomiting | 0 (0) | 1 (1) | 4 (13) | 0 (0) | 5 (3) |
Abbreviations: AST, aspartate aminotransferase; GA, gestational age; PNA, postnatal age.
a Defined per the local site.