Table 2 Number (%) of participants with composite adverse events and treatment differences
Composite adverse event | Number (%) | Treatment difference (95% CI) | |||
|---|---|---|---|---|---|
12 mg (N = 652) | 40 mg (N = 652) | Placebo (N = 653) | 12 mg vs. placebo | 40 mg vs. placebo | |
Delirium-like events | 13 (2.0) | 31 (4.8) | 22 (3.4) | − 1.38 (− 3.26, 0.40) | 1.39 (− 0.78, 3.63) |
Injury or fall | 132 (20.2) | 151 (23.2) | 103 (15.8) | 4.47 (0.30, 8.65) | 7.39 (3.10, 11.68) |
Overactive bladder symptoms | 12 (1.8) | 27 (4.1) | 12 (1.8) | 0.00 (− 1.56, 1.57) | 2.30 (0.48, 4.31) |
Psychotic symptoms | 30 (4.6) | 36 (5.5) | 20 (3.1) | 1.54 (− 0.56, 3.73) | 2.46 (0.27, 4.77) |
Rash, dermatitis, urticaria | 79 (12.1) | 66 (10.1) | 38 (5.8) | 6.30 (3.24, 9.47) | 4.30 (1.38, 7.32) |
Sleep disturbance | 67 (10.3) | 55 (8.4) | 31 (4.7) | 5.53 (2.71, 8.48) | 3.69 (1.01, 6.47) |
Syncopal like events | 26 (4.0) | 27 (4.1) | 17 (2.6) | 1.38 (− 0.58, 3.44) | 1.54 (− 0.44, 3.62) |