Table 3.
Adverse drug reactions
| Cumulative total in the specified use–results study (N = 304) | ||
|---|---|---|
| Total | Serious | |
| Adverse events | ||
| Number of subjects (events) | 99 (220) | 53 (89) |
| Incidence (%) | 32.56 | 17.43 |
| Adverse reactions | ||
| Number of subjects (events) | 25 (33) | 11 (13) |
| Incidence (%) | 8.22 | 3.62 |
| Type of adverse reaction | ||
| Infections and infestations | 14 (4.61) | 8 (2.63) |
| Pneumonia | 3 (0.99) | 3 (0.99) |
| Respiratory syncytial virus infection | 3 (0.99) | 2 (0.66) |
| Influenza | 2 (0.66) | |
| Nasopharyngitis | 2 (0.66) | |
| Septic shocka | 1 (0.33) | 1 (0.33) |
| Pneumonia, bacterial | 1 (0.33) | 1 (0.33) |
| Acute sinusitisa | 1 (0.33) | |
| Bronchitis | 1 (0.33) | 1 (0.33) |
| Conjunctivitisa | 1 (0.33) | |
| Gastroenteritisa | 1 (0.33) | |
| Device-related infectiona | 1 (0.33) | 1 (0.33) |
| Respiratory, thoracic, and mediastinal disorders | 6 (1.97) | 2 (0.66) |
| Upper respiratory tract inflammation | 5 (1.64) | 1 (0.33) |
| Asthmaa | 1 (0.33) | 1 (0.33) |
| Gastrointestinal disorders | 2 (0.66) | |
| Diarrhea | 2 (0.66) | |
| Hepatobiliary disorders | 2 (0.66) | 1 (0.33) |
| Liver disordera | 1 (0.33) | |
| Drug-induced liver injurya | 1 (0.33) | 1 (0.33) |
| Neoplasms, benign, malignant, and unspecified (including cysts and polyps) | 1 (0.33) | 1 (0.33) |
| Nephroblastomaa | 1 (0.33) | 1 (0.33) |
| Immune system disorders | 1 (0.33) | |
| Graft-versus-host diseasea | 1 (0.33) | |
| Endocrine disorders | 1 (0.33) | |
| Adrenal insufficiencya | 1 (0.33) | |
| Metabolism and nutrition disorders | 1 (0.33) | |
| Hypokalemiaa | 1 (0.33) | |
| Vascular disorders | 1 (0.33) | |
| Hypertensiona | 1 (0.33) | |
| Renal and urinary disorders | 1 (0.33) | |
| Nephrotic syndromea | 1 (0.33) | |
Adverse reactions were classified using Medical Dictionary for Regulatory Activities/Japanese Version 18.1
aAdverse reactions/infections previously not mentioned in the precautions of the Japanese package insert for palivizumab