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_22
Snippet: The Intent-To-Treat (ITT) population included all screened subjects who fulfilled eligibility criteria for RI-002 treatment. All ITT subjects who received at least one RI-002 infusion in the study (referenced to as mITT) were the primary population for efficacy and safety analyses. The PK population includes all mITT subjects who enrolled to participate in the PK portion of the study and who had sufficient plasma samples drawn to derive PK parame.....
Document: The Intent-To-Treat (ITT) population included all screened subjects who fulfilled eligibility criteria for RI-002 treatment. All ITT subjects who received at least one RI-002 infusion in the study (referenced to as mITT) were the primary population for efficacy and safety analyses. The PK population includes all mITT subjects who enrolled to participate in the PK portion of the study and who had sufficient plasma samples drawn to derive PK parameters.
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