title: Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.
abstract: OBJECTIVE
  To evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice.
  
  
  METHODS
  High-risk children prophylaxed against RSV infection were recruited into a prospective, observational, Canadian RSV Evaluation Study of Palivizumab (CARESS) registry with active, serious adverse event (SAE) monitoring from 2008 to 2013. SAE reports were systematically collected and assessed for severity and relationship to palivizumab. Data were analyzed by Chi-square or Fisher Exact Tests to examine group differences in proportions.
  
  
  RESULTS
  13025 infants received 57392 injections. Hospitalizations for respiratory-related illness (RIH) were reported in 915 patients, and SAEs other than RIH were reported in 52 patients. Of these, 6 (0.05%) patients had a total of 14 hypersensitivity reactions that were deemed possibly or probably related to palivizumab (incidence: 2.8 per 10,000 patient-months). The SAEs of 42 patients were assessed as not related to palivizumab. SAEs in the remaining 4 patients were not classifiable as their records were incomplete. There were no significant demographic predictors of SAE occurrence.
  
  
  CONCLUSIONS
  Under active surveillance, a small proportion of infants in the CARESS registry experienced SAEs that had a potential relationship with palivizumab and these appeared to be unpredictable in terms of onset. Palivizumab appears to be a safe and well-tolerated antibody for RSV prophylaxis in high-risk children in routine practice.
authors.affiliation: Medical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Jinghan Jenny
authors.initials: JJ
authors.lastname: Chen
authors.affiliation: Medical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Parco
authors.initials: P
authors.lastname: Chan
authors.affiliation: Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Bosco
authors.initials: B
authors.lastname: Paes
authors.affiliation: Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Ian
authors.initials: I
authors.lastname: Mitchell
authors.affiliation: Medical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Abby
authors.initials: A
authors.lastname: Li
authors.affiliation: Medical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Krista L
authors.initials: KL
authors.lastname: Lanctôt
mesh_terms: D004342:Drug Hypersensitivity / Q000453:epidemiology*; D005260:Female; D006760:Hospitalization; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D000069455:Palivizumab / Q000009:adverse effects* / Q000627:therapeutic use; D011446:Prospective Studies; D012042:Registries; D018357:Respiratory Syncytial Virus Infections / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D000069455:Palivizumab