Skip to main content

Advertisement

Table 1 Summary of adverse events by system organ class

From: Further analyses of the safety of verubecestat in the phase 3 EPOCH trial of mild-to-moderate Alzheimer’s disease

System organ class Number (%) Treatment difference (95% CIa)
12 mg (N = 652) 40 mg (N = 652) Placebo (N = 653) 12 mg vs. placebo 40 mg vs. placebo
Any
 ≥ 1 adverse event 582 (89.3) 601 (92.2) 533 (81.6) 7.64 (3.84, 11.48) 10.55 (6.96, 14.23)
Gastrointestinal
 Diarrhea 53 (8.1) 57 (8.7) 38 (5.8) 2.31 (− 0.46, 5.14) 2.92 (0.10, 5.81)
 Gastritis 11 (1.7) 9 (1.4) 3 (0.5) 1.23 (0.13, 2.59) 0.92 (− 0.14, 2.20)
Infections
 Conjunctivitis 5 (0.8) 13 (2.0) 4 (0.6) 0.15 1.38 (0.17, 2.84)
Injury
 Head injury 3 (0.5) 9 (1.4) 2 (0.3) 0.15 1.07 (0.10, 2.33)
 Skin abrasion 9 (1.4) 15 (2.3) 6 (0.9) 0.46 (− 0.78, 1.79) 1.38 (0.02, 2.95)
Investigations
 Weight decreased 42 (6.4) 42 (6.4) 20 (3.1) 3.38 (1.10, 5.81) 3.38 (1.10, 5.81)
Metabolism/nutrition
 Decreased appetite 16 (2.5) 29 (4.4) 16 (2.5) 0.00 (− 1.76, 1.77) 2.00 (0.02, 4.11)
Musculoskeletal and connective tissue
 Muscle spasms 9 (1.4) 16 (2.5) 6 (0.9) 0.46 (− 0.78, 1.79) 1.54 (0.15, 3.13)
 Pain in extremity 14 (2.1) 20 (3.1) 8 (1.2 0.92 (− 0.52, 2.49) 1.84 (0.29, 3.60)
Nervous system
 Dizziness 31 (4.8) 53 (8.1) 32 (4.9) − 0.15 (− 2.53, 2.23) 3.23 (0.56, 5.99)
Psychiatric
 Anxiety 39 (6.0) 46 (7.1) 24 (3.7) 2.31 (− 0.02, 4.73) 3.38 (0.96, 5.93)
 Insomnia 35 (5.4) 29 (4.4) 20 (3.1) 2.31 (0.13, 4.60) 1.39 (− 0.70, 3.55)
 Sleep disorder 18 (2.8) 8 (1.2) 3 (0.5) 2.30 (1.04, 3.91) 0.77 (− 0.27, 2.00)
 Suicidal ideation 39 (6.0) 38 (5.8) 21 (3.2) 2.77 (0.51, 5.15) 2.61 (0.37, 4.98)
Renal and urinary
 Hypertonic bladder 2 (0.3) 7 (1.1) 1 (0.2) 0.15 0.92 (0.10, 2.06)
Skin and subcutaneous tissue
 Alopecia 1 (0.2) 7 (1.1) 0 (0.0) 0.15 1.07 (0.49, 2.20)
 Hair color changes 12 (1.8) 16 (2.5) 0 (0.0) 1.84 (1.06, 3.19) 2.45 (1.52, 3.95)
 Urticaria 14 (2.1) 12 (1.8) 3 (0.5) 1.69 (0.52, 3.16) 1.38 (0.26, 2.78)
  1. Data shown are for adverse events with incidence of ≥ 1% in one or more verubecestat groups and where the lower bound of the 95% confidence interval for the difference versus placebo is > 0 in at least one verubecestat group
  2. aConfidence intervals only produced for those comparisons for which at least one of the treatment groups (verubecestat or placebo) had an incidence ≥ 1%