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_16
Snippet: Assuming time-weighted average change (standard deviation) in RSV log 10 viral load from day 1 to day 9 of -1.5 (1.75) log 10 copies/mL in placebo-treated patients, 25 patients per treatment group were planned to provide approximately 85% power to detect a ≥1.5 log 10 decrease in the primary endpoint in patients receiving presatovir relative to placebo using a 2-sided α of 0.05. We estimated 85% of patients would be evaluable and planned to en.....
Document: Assuming time-weighted average change (standard deviation) in RSV log 10 viral load from day 1 to day 9 of -1.5 (1.75) log 10 copies/mL in placebo-treated patients, 25 patients per treatment group were planned to provide approximately 85% power to detect a ≥1.5 log 10 decrease in the primary endpoint in patients receiving presatovir relative to placebo using a 2-sided α of 0.05. We estimated 85% of patients would be evaluable and planned to enroll 60 patients.
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