Table 3.

Most Frequently Reported Adverse Events That Were Judged by the Blinded Investigator as Potentially Related to Study Drug*

PlaceboPalivizumabP Value
Fever3.0%2.8%.870
Nervousness2.6%2.5%.865
Injection site reaction1.6%2.3%.444
Diarrhea0.4%1.0%.357
Rash0.2%0.9%.179
AST increased0.6%0.5%.726
URI0.4%0.5%1.000
Liver function abnormal0.2%0.3%1.000
ALT increased0.4%0.3%.670
Vomiting0.4%0.3%.670
Cough0.2%0.3%1.000
Rhinitis0.6%0.3%.406
  • Abbreviations: AST, aspartate aminotransferase; URI, upper respiratory tract illness; ALT, alanine aminotransferase.

  • * Reported events in at least 3 children in the palivizumab group are provided along with the corresponding incidence in the placebo group. These represent adverse events reported by the investigator and include those identified by protocol mandated testing and other clinically indicated evaluations.

  • Refers primarily to elevations of both AST and ALT.