Efficacy, Safety, and Pharmacokinetics of a New 10 % Liquid Intravenous Immunoglobulin Containing High Titer Neutralizing Antibody to RSV and Other Respiratory Viruses in Subjects with Primary Immunodeficiency Disease

Wasserman, Richard L.; Lumry, William; Harris, James; Levy, Robyn; Stein, Mark; Forbes, Lisa; Cunningham-Rundles, Charlotte; Melamed, Isaac; Kobayashi, Ai Lan; Du, Wei; Kobayashi, Roger

Descriptive statistics were provided for the overall population and by treatment regimen (n, mean, SD, minimum, median, and maximum for continuous variables and counts and percentages for categorical variables). Infections were identified based on reported treatment emergent adverse events that were mapped to MedDRA 'Infection and Infestations' System Organ Class. The concomitant medications records were used to identify all antibiotic medications based on the WHO Drug Coding of ATC level, route and indication. Annualized rate (per person per year) was calculated by total episodes (e.g., total infection events) or total days (e.g., days lost due to infection) divided by total person-years. The one-sided 95 % upper bound for annualized rate was estimated from a general linear model for Poisson distribution with only the intercept parameter. Quartiles and mean days to resolution of infections were estimated using Kaplan-Meier estimates.