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