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_12
Snippet: Clinical assessments included vital signs, weight, and oxygen saturation by pulse oximetry; laboratory safety assessments included complete blood counts and serum electrolyte and liver enzyme measurements. Patients were observed without oxygen supplementation at each study visit, and the lowest oxygen saturation during observation was recorded. Cardiac safety was assessed via local electrocardiograms and troponin testing on days 1, 17, and 28. Ad.....
Document: Clinical assessments included vital signs, weight, and oxygen saturation by pulse oximetry; laboratory safety assessments included complete blood counts and serum electrolyte and liver enzyme measurements. Patients were observed without oxygen supplementation at each study visit, and the lowest oxygen saturation during observation was recorded. Cardiac safety was assessed via local electrocardiograms and troponin testing on days 1, 17, and 28. Additional safety assessments included evaluation of adverse events (AEs) and documentation of all concomitant medications, hospitalizations, rehospitalizations, intensive care unit care, invasive and noninvasive mechanical ventilation, and supplemental oxygen use (≥2 L/min).
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