Author: 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
Title: 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 Document date: 2016_6_20
ID: 1mmn0f98_16
Snippet: The primary efficacy endpoint was the demonstration of a serious bacterial infection (SBI) rate of less than 1.0 per person-year during the 12-month treatment with RI-002. Secondary efficacy endpoints included: the incidence of all infections of any kind, the number of days lost from work/school/usual activity due to infection and their treatment, the number of unscheduled visits to physician/ER due to infections, the time to resolution of infect.....
Document: The primary efficacy endpoint was the demonstration of a serious bacterial infection (SBI) rate of less than 1.0 per person-year during the 12-month treatment with RI-002. Secondary efficacy endpoints included: the incidence of all infections of any kind, the number of days lost from work/school/usual activity due to infection and their treatment, the number of unscheduled visits to physician/ER due to infections, the time to resolution of infections, the number of hospitalizations and days of hospitalizations due to infections, the number of days of antibiotic therapy (prophylactic and treatment), the relationship among dose, trough level and risk of serious and non-serious infections, and trough total IgG and specific antibody levels.
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