Table 4.
Summary of safety in the randomized clinical trials
| Population | Study | Study drug dose | Subjects with ≥1 at least possibly related, % | Most commonly reported AEs, % | Commonly reported SAEs, % | Injection site reaction, % | AEs leading to D/C, % | Deaths, % | |
|---|---|---|---|---|---|---|---|---|---|
| AE | SAE | ||||||||
| BPD/CLDP, prematurity, or CHD | Expanded Access [32] | Palivizumab (n = 565) | 6.9 | NA | Fever 1.5%, diarrhea 0.8%, nervousness/irritability 0.8%a | NA | 2.3a | 1.9 | 0.4 |
| Lacaze-Masmonteil et al. [38] | Palivizumab, season 1 (n = 71) | NA | 0 | Infection, injection site reaction, diarrhea 1.4% eacha | Bronchiolitis 5.6%, BPD aggravation 2.8%, vomiting 2.8% | 1.4a | 0 | 0 | |
| Palivizumab, season 2 (n = 63) | NA | 0 | Fever 3.2%; anorexia, epistaxis, ataxia 1.6% eacha | Bronchiolitis 4.8%, fever 3.2% | 0a | 0 | 0 | ||
| Turti et al. [40] | Palivizumab (n = 100) | 2.0 | 0 | Rhinitis, dermatitis 1.0% each | NA | NA | 1.0 | 0 | |
| BPD/CLDP or prematurity | Subramanian et al. [29] | Placebo (n = 20) | 15.0 | NA | NA | NA | NA | 0 | 5.0 |
| Palivizumab 15 mg/kg (n = 22) | 23.0 | NA | NA | NA | NA | 0 | 0 | ||
| IMpact-RSV [24] | Placebo (n = 500) | 10.0 | NA | Fever 3.0%, nervousness 2.6%, injection site reaction 1.6%a | NA | 1.8 | NA | 1.0 | |
| Palivizumab 15 mg/kg (n = 1,002) | 11.0 | NA | Fever 2.8%, nervousness 2.5%, injection site reaction 2.3%a | NA | 2.7 | 0.3 | 0.4 | ||
| Carbonell-Estrany et al. [70] | Palivizumab 15 mg/kg (n = 3,298) | NA | NA | URTI 30.1%, pyrexia 16.9%, rhinitis 13.5%, otitis media 12.8%, bronchiolitis 9.9%, teething 8.6%, diarrhea 8.5%, respiratory disorder 8.4%, nasal congestion 8.0%, conjunctivitis 7.6%, gastroenteritis 7.1%, bronchitis 6.9%, constipation 6.9%, cough 6.5%, gastroesophageal reflux disease 6.3%, diaper dermatitis 5.8%, vomiting 5.2%, irritability 5.0% | NA | 2.7 | 0.3 | 0.1 | |
| Prematurity | MAKI [30] | Placebo (n = 215) | NA | NA | NA | NA | NA | NA | 0 |
| Palivizumab 15 mg/kg (n = 214) | NA | NA | NA | NA | NA | NA | 0 | ||
| CHD | Cardiac [23] | Placebo (n = 648) | 6.9 | 0.5 | URTI 46.1%, fever 23.9%, conjunctivitis 9.3%, cyanosis 6.9%, infection 2.9%, arrhythmia 1.7% | Arrhythmia 0.3%, cyanosis 2.2% | 2.2 | 0a | 4.2 |
| Palivizumab 15 mg/kg (n = 639) | 7.2 | 0 | URTI 47.4%, fever 27.1%, conjunctivitis 11.3%, cyanosis 9.1%, infection 5.6%, arrhythmia 3.1% | Arrhythmia 0.2%, cyanosis 3.6% | 3.4 | 0a | 3.3 | ||
| Feltes et al. [71] | Palivizumab 15 mg/kg (n = 612) | 8.8 | 1.0 | Pyrexia 29.2%, URTI 28.1%, rhinitis 12.6%, cough 11.6%, otitis media 11.4%, gastroenteritis 10.8%, diarrhea 10.6%, nasopharyngitis 9.5%, vomiting 8.3%, Tetralogy of Fallot 8.2%, bronchitis 7.8%, rhinorrhea 7.4%, ventricular septal defect 6.2%, teething 5.9%, pneumonia 5.9%, blood urea increased 5.6%, nasal congestion 5.4%, constipation 5.1%, viral infection 5.1%, dermatitis diaper 5.1% | Tetralogy of Fallot 8.0%, ventricular septal defect 5.9%, pneumonia 3.8%, atrioventricular septal defect 3.6% | NA | 0.2 | 1.6 | |
Detailed characteristics of these studies are presented in Appendix Table A1. The Tavsu et al. 2014 [31] trial did not report safety events and was therefore not included in this table
AE adverse event, BPD bronchopulmonary dysplasia, CHD congenital heart disease, CLDP chronic lung disease of prematurity, D/C discontinuation of study drug, NA not available, SAE serious adverse event, URTI upper respiratory tract infection
aConsidered at least possibly related to study drug