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Table 4 Summary of all-causality treatment-emergent AEs

From: A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer’s disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil

  Placebo run-in (n = 195) SAM-760 (n = 91)a Placebo (n = 94) Placebo washout (n = 164)
Number of AEs 39 53 62 22
Number of subjects (%)
 With AEs 25 (12.8) 38 (41.8) 39 (41.5) 19 (11.6)
 With serious AEs 1 (0.5) 2 (2.2) 2 (2.1) 4 (2.4)
 With severe AEs 2 (1.0) 0 0 2 (1.2)
 Discontinued due to AEs 2 (1.0) 2 (2.2) 0 1 (0.6)
 Dose reduced or temporary discontinuation due to AEs 1 (0.5) 2 (2.2) 1 (1.1) 0
  1. aOne subject was randomized but not treated; therefore n = 91 not n = 92
  2. AE adverse event