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Table 2 Treatment emergent adverse event profiles during study period (safety population)

From: Safety and tolerability of donepezil 23 mg with or without intermediate dose titration in patients with Alzheimer’s disease taking donepezil 10 mg: a multicenter, randomized, open-label, parallel-design, three-arm, prospective trial

Variables, incidence (95% CI) Group 1, 15 mg (n = 51) Group 2, 10/23 mg (n = 55) Group 3, no titration (n = 54) p value G1,2 vs G3
AE_Total 28/51, 54.9% (40.34~68.87) 37/55, 67.3% (55.32~79.34) 36/54, 66.7% (52.56~78.94) 0.34
AESI 20/51, 39.2% (25.83~53.87) 22/51, 40.0% (27.02~54.09) 25/54, 46.3% (32.63~60.39) 0.72
AE-GI symptoms 17/51, 33.3% (20.73~47.89) 20/55, 36.4% (23.85~50.47) 24/54, 44.4% (30.88~58.56) 0.48
Anorexia 10/51, 19.6% (9.82~33.11) 14/55, 25.5% (14.71~39.05) 12/54, 22.2% (12.03~35.58) 0.77
Dizziness 4/51, 7.8% (2.16~18.82) 8/55, 14.5% (6.50~26.66) 12/54, 22.2% (12.03~35.58) 0.07
Nausea 5/51, 9.8% (3.26~21.41) 5/55, 9.1% (3.02~19.97) 13/54, 24.1% (13.51~37.67) 0.04*
Vomiting 4/51, 7.8% (2.16~18.82) 7/55, 12.7% (5.26~24.45) 9/54, 16.7% (7.94~29.33) 0.39
Generalized weakness 4/51, 7.8% (2.16~18.82) 8/55, 14.5% (6.50~26.66) 6/54, 11.1% (4.18~22.62) 0.97
Weight loss 4/51, 7.8% (2.16~18.82) 5/55, 9.1% (3.02~19.97) 3/54, 5.6% (1.18~15.45) 0.81
Diarrhea 2/51, 3.9% (0.47~13.43) 5/55, 9.1% (3.02~19.97) 6/54, 11.1% (4.18~22.62) 0.41
Dyspepsia 0/51, 0% (0~6.98) 5/55, 9.1% (3.02~19.97) 3/54, 5.6% (1.18~15.45) 1.00
Urinary frequency 3/51, 5.9% (1.23~16.24) 5/55, 9.1% (3.02~19.97) 0/54, 0% (0~6.60) 0.05
Increased neuropsychiatric sx. 0/51, 0% (0~6.98) 2/55, 3.6% (0~6.60) 3/54, 5.6% (1.18~15.45) 0.34
Insomnia 1/51, 2.0% (0.1~10.45) 3/55, 5.5% (1.14~15.12) 0/54, 0% (0~6.60) 0.30
Headache 0/51, 0% (0~6.98) 0/55, 0% (0~6.49) 3/54, 5.6% (1.18~15.45) 0.07
Tremor 1/51, 2.0% (0.1~10.45) 1/55, 1.8% (0~9.72) 1/54, 1.9% (0~9.72) 1.00
Dropout d/t AEs 13, 25.5% 19, 34.5% 18, 33.3% 0.69
AESI, severity (mild/moderate/severe) 19/1/0 18/4/0 19/5/1 0.19
Most common AEs leading to discontinuation Anorexia 7.8%, nausea/vomiting 5.9%, dizziness 3.9% Anorexia 10.9%, nausea/vomiting 7.3%, generalized weakness 7.3% Nausea/vomiting 18.5%, dizziness 14.8%, anorexia 7.4% n/a
  1. *Significantly different incidences between titration and no-titration groups. AE-GI symptoms include anorexia, nausea, vomiting, and diarrhea. AESI includes nausea, vomiting, diarrhea, anorexia, abdominal pain, headache, bradycardia, and weight loss. Severities of AEs were rated as mild, moderate, or severe
  2. AE adverse event, AESI adverse events of special interests