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) |