TABLE 2.
Protocol targeted adverse events in infants
| Adverse event | Gradea | No. of instances (in 13 infants) | Relationship to treatment |
|---|---|---|---|
| Anemia | 3 | 3 | Possibly related |
| Neutropenia | 3 | 3 | Possibly related |
| Hyperbilirubinemia | 4 | 1 | Possibly related |
| 4 | 1 | Nonrelated | |
| Hyperkalemia | 3 | 1 | Nonrelated |
| 4 | 1 | Nonrelated | |
| Hyperglycemia | 3 | 1 | Nonrelated |
| Hypoglycemia | 3 | 1 | Nonrelated |
| Clinical events | 7 | ||
| Hyperbilirubinemia | 2 | Nonrelated | |
| Asthma | 1 | Nonrelated | |
| Bronchiolitis | 1 | Nonrelated | |
| Oral candidiasisb | 1 | Nonrelated | |
| Meningitis | 1 | Nonrelated | |
| Transient tachypnea of the newborn | 1 | Nonrelated |
a
Only laboratory abnormalities and signs and symptoms were graded. Protocol-targeted, infant adverse events included all grade 3 and 4 events, with drug discontinuation except for anemia and neutropenia and with repeat testing performed within 72 h and discontinued if toxicity persisted. All adverse events were reviewed by the study team and classified as definitely related, possibly related, or not related to study medications.
b
The infant was infected.