Table 2.
Serious adverse events
SAE, n (%) | Lyophilized palivizumab (n = 202) | Liquid palivizumab (n = 211) | Total (n = 413) |
---|---|---|---|
Total number of subjects reporting ≥1 SAE | 12 (5.9) | 18 (8.5) | 30 (7.3) |
Bronchiolitis | 3 (1.5) | 6 (2.8) | 9 (2.2) |
Gastroenteritis | 2 (1.0) | 2 (0.9) | 4 (1.0) |
Respiratory distress | 2 (1.0) | 0 (0.0) | 2 (0.5) |
Viral infection | 0 (0.0) | 2 (0.9) | 2 (0.5) |
Cleft lip | 1 (0.5) | 1 (0.5) | 2 (0.5) |
Inguinal hernia | 1 (0.5) | 1 (0.5) | 2 (0.5) |
Abscess | 1 (0.5) | 0 (0.0) | 1 (0.2) |
Anal fissure | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Apnea | 1 (0.5) | 0 (0.0) | 1 (0.2) |
Asphyxia | 1 (0.5) | 0 (0.0) | 1 (0.2) |
Bronchopneumonia | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Cellulitis | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Complex partial seizures | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Convulsions | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Craniosynostosis | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Dehydration | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Dyspnea | 1 (0.5) | 0 (0.0) | 1 (0.2) |
Failure to thrive | 1 (0.5) | 0 (0.0) | 1 (0.2) |
Gastroenteritis rotavirus | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Gastroesophageal reflux disease | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Hydronephrosis | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Infectious croup | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Lymphadenitis | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Occult blood positive | 1 (0.5) | 0 (0.0) | 1 (0.2) |
Umbilical hernia | 0 (0.0) | 1 (0.5) | 1 (0.2) |
SAE Serious adverse event