Selected article for: "aged year and study population"
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_27
    Snippet: Efficacy RI-002 was efficacious in the treatment of subjects with PIDD aged 3 to 74 years, over a 1-year period. The efficacy of RI-002 (Table 2 ) was demonstrated by the absence of any SBIs in the study population. The observed incidence of zero (0) SBIs in 55.88 subject years (20,396 total study days) of treatment resulted in a SBI rate below the criteria of <1.0 SBI per subject per year set by FDA. Other key efficacy secondary endpoints includ.....
    Document: Efficacy RI-002 was efficacious in the treatment of subjects with PIDD aged 3 to 74 years, over a 1-year period. The efficacy of RI-002 (Table 2 ) was demonstrated by the absence of any SBIs in the study population. The observed incidence of zero (0) SBIs in 55.88 subject years (20,396 total study days) of treatment resulted in a SBI rate below the criteria of <1.0 SBI per subject per year set by FDA. Other key efficacy secondary endpoints included lost days from work/school/daycare due to infection (1.66 days per subject per year), unscheduled emergency room/medical visits due to infection (0.966 visits per subject per year), and hospitalizations due to infection (0.018 hospitalizations per subject per year).

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