Author: Beigel, John H.; Tebas, Pablo; Elie-Turenne, Marie-Carmelle; Bajwa, Ednan; Bell, Todd E.; Cairns, Charles B.; Shoham, Shmuel; Deville, Jaime G.; Feucht, Eric; Feinberg, Judith; Luke, Thomas; Raviprakash, Kanakatte; Danko, Janine; O’Neil, Dorothy; Metcalf, Julia A.; King, Karen; Burgess, Timothy H.; Aga, Evgenia; Lane, H. Clifford; Hughes, Michael D.; Davey, Richard T.
Title: A Randomized Study of Immune Plasma for the Treatment of Severe Influenza Document date: 2017_5_15
ID: 2g22oqf2_16
Snippet: All efficacy results are presented for the Primary Efficacy Population (PEP) unless otherwise noted. The PEP included all randomized participants with influenza infection confirmed by PCR from Day 0 by the central laboratory. Analysis is per Intention-to-Treat (ITT). The logrank test and Cox proportional hazards model were used to compare the primary endpoint between treatments using ITT approach. For the primary endpoint, participants who died w.....
Document: All efficacy results are presented for the Primary Efficacy Population (PEP) unless otherwise noted. The PEP included all randomized participants with influenza infection confirmed by PCR from Day 0 by the central laboratory. Analysis is per Intention-to-Treat (ITT). The logrank test and Cox proportional hazards model were used to compare the primary endpoint between treatments using ITT approach. For the primary endpoint, participants who died without prior normalization were censored after Day 28. Participants who were not evaluable at a scheduled visit (either due to prior loss to follow-up or an incomplete or missing evaluation) were considered as not having a normalized respiratory status at that visit. Adverse event data, coded using MedDRA, are presented by treatment received.
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