Adverse Event, n (%) | DLX_DLX | PLA_DLX |
---|---|---|
N = 166 | N = 175 | |
Patients with ≥1 TEAE | 42 (25.3) | 81 (46.3) |
Dry mouth | 3 (1.8) | 15 (8.6) |
Somnolence | 4 (2.4) | 10 (5.7) |
Alanine aminotransferase increased | 3 (1.8) | 10 (5.7) |
Nausea | 5 (3.0) | 8 (4.6) |
Aspartate aminotransferase increased | 1 (0.6) | 8 (4.6) |
Dizziness | 3 (1.8) | 7 (4.0) |
Constipation | 1 (0.6) | 7 (4.0) |
Weight decreased | 0 | 4 (2.3) |