Author: Marty, Francisco M; Chemaly, Roy F; Mullane, Kathleen M; Lee, Dong-Gun; Hirsch, Hans H; Small, Catherine B; Bergeron, Anne; Shoham, Shmuel; Ljungman, Per; Waghmare, Alpana; Blanchard, Elodie; Kim, Yae-Jean; McKevitt, Matt; Porter, Danielle P; Jordan, Robert; Guo, Ying; German, Polina; Boeckh, Michael; Watkins, Timothy R; Chien, Jason W; Dadwal, Sanjeet S
Title: A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract Document date: 2019_12_3
ID: sl45z4i0_14
Snippet: The primary endpoint was time-weighted average change in nasal RSV viral load measured by RT-qPCR (log 10 copies/mL) from day 1 to day 9. Key secondary endpoints were number of supplemental oxygen-free days [3] , proportion of patients developing respiratory failure requiring invasive or noninvasive mechanical ventilation, and all-cause mortality through day 28. Prespecified exploratory endpoints are described in Supplemental methods. Safety was .....
Document: The primary endpoint was time-weighted average change in nasal RSV viral load measured by RT-qPCR (log 10 copies/mL) from day 1 to day 9. Key secondary endpoints were number of supplemental oxygen-free days [3] , proportion of patients developing respiratory failure requiring invasive or noninvasive mechanical ventilation, and all-cause mortality through day 28. Prespecified exploratory endpoints are described in Supplemental methods. Safety was assessed from AEs and clinical and laboratory parameters.
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