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Table 3 Summary of treatment-emergent adverse events from both studies, n (%)

From: ABT-126 monotherapy in mild-to-moderate Alzheimer’s dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension

  Double-blind study Open-label study
Placebo (n = 104) ABT-126 25 mg (n = 77) ABT-126 50 mg (n = 107) ABT-126 75 mg (n = 73) Donepezil 10 mg (n = 75) ABT-126 75 mg (n = 349)
Any AE 56 (53.8) 42 (54.5) 62 (57.9) 38 (52.1) 47 (62.7) 167 (47.9)
Possibly relateda 20 (19.2) 16 (20.8) 27 (25.2) 14 (19.2) 24 (32.0) 66 (18.9)
Discontinued due to AE 4 (3.8) 5 (6.5) 7 (6.5) 2 (2.7) 9 (12.0) 13 (3.7)
Severe AE 2 (1.9) 3 (3.9) 2 (1.9) 1 (1.4) 3 (4.0) 18 (5.2)
Serious AE 5 (4.8) 6 (7.8) 7 (6.5) 2 (2.7) 3 (4.0) 17 (4.9)
Deathsb 0 0 0 0 2 (2.7)c 4 (1.1)d
AEs reported by ≥ 5.0 % of subjects in any treatment group in the double-blind study (MedDRA preferred term)
Constipatione 3 (2.9) 7 (9.1) 16 (15.0)e 3 (4.1) 2 (2.7) 17 (4.9)
Headache 7 (6.7) 5 (6.5) 4 (3.7) 5 (6.8) 8 (10.7) 11 (3.2)
Fall 4 (3.8) 4 (5.2) 5 (4.7) 3 (4.1) 5 (6.7) 15 (4.3)
Nausea 3 (2.9) 1 (1.3) 4 (3.7) 2 (2.7) 6 (8.0) 7 (2.0)
Diarrhea 2 (1.9) 2 (2.6) 4 (3.7) 2 (2.7) 4 (5.3) 6 (1.7)
Anxiety 1 (1.0) 1 (1.3) 7 (6.5) 2 (2.7) 0 6 (1.7)
Depressed mood 1 (1.0) 1 (1.3) 0 0 4 (5.3) 3 (0.9)
  1. aAny AE determined by the investigator as having a reasonable possibility of being related to the study drug
  2. bIncludes all deaths, whether or not considered treatment emergent. In both studies all events related to deaths were considered as having no reasonable possibility of being related to the study drug
  3. cCerebrovascular accident (day 6) and septic shock (day 143)
  4. dAdvanced age (open-label extension day 7); cerebral infarction, brain edema, brain stem syndrome, and pulmonary edema (open-label extension day 40); arterial thrombosis and gastrointestinal necrosis (open-label extension day 21); and myocardial infarction (open-label extension day 172)
  5. eStatistically significant vs placebo (P = 0.0019 for ABT-126 combined and P = 0.003 for ABT-126 50 mg)
  6. All data are presented as n (%)
  7. AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, n number of subjects