Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients

HIGHLIGHTS

• who: Intravenous immunoglobulin, IVIG and H. W., Schroeder Jr. from the primary efficacy endpoint as the rate of acute serious bacterial infections (SBIs) during the year of treatment with the study IVIGBased on the FDA's examination of historical data, the SBI rate was to be 1., per subject per year at thelevel of significance. SBIs were defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess. Essential diagnostic features for each infection were described. Safety endpoints were the overall incidence of adverse events (AEs) (regardless of causality) that occurred during or within . . .
  

   

  

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