Table 1.
Adverse Events | Serious Adverse Events | |||
---|---|---|---|---|
Laboratory Event | AE Values | Infants n=746 (%) |
SAE Values | Infants n=746 (%) |
Hypernatremia | >155 mmol/L | 18 (2) | >160 mmol/L | 1 (0.1) |
Hypokalemia | <3 mmol/L | 43 (6) | <2.5 mmol/L | 10 (1) |
Elevated creatinine | >1.7 mg/dL | 14 (2) | >3.0 mg/dL | 0 (0) |
Leukopenia | <5000/mm3 | 93 (12) | <2000/mm3 | 7 (1) |
Thrombocytopenia | <100,000/mm3 | 242 (32) | <30,000/mm3 | 70 (9) |
Low hematocrit | <37% | 263 (35) | <30% | 60 (8) |
Prolonged prothrombin time | >15 sec | 16 (2) | - | - |
Prolonged partial thromboplastin time | >50 sec | 9 (1) | - | - |
High AST | >600 U/L | 7 (1) | >1200 U/L | 2 (0.3) |
High ALT | >225 U/L | 4 (0.5) | >450 U/L | 2 (0.3) |
Abbreviations: AST, aspartate aminotransferase; ALT, alanine transaminase