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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