Selected article for: "day mean and upper limit"
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_33
    Snippet: RI-002 was well tolerated in this study. The proportion of study infusions with a TAAE was 0.142 with an upper onesided 95 % confidence limit of 0.164, indicating that the study met the target (<0.40) for this safety endpoint. During the (Table 5 ). There were 793 infusions administered during the study, with an average of 13.4 infusions administered per subject. Of 793 study infusions, one was not completed as planned, and two infusions (in 2 di.....
    Document: RI-002 was well tolerated in this study. The proportion of study infusions with a TAAE was 0.142 with an upper onesided 95 % confidence limit of 0.164, indicating that the study met the target (<0.40) for this safety endpoint. During the (Table 5 ). There were 793 infusions administered during the study, with an average of 13.4 infusions administered per subject. Of 793 study infusions, one was not completed as planned, and two infusions (in 2 different subjects) were interrupted due to an AE and completed on the next day. The mean (SE) planned weight adjusted dose of RI-002 administered during this study was 505.2 (4.84) mg/kg, with a range of 284 to 1008 mg/kg.

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