Table 2.
Adverse events occurring in ≥3% of patients in either phase
| Adverse events, n (%) | Titration phase (n=506) | Long-term treatment phase (n=435) |
|---|---|---|
| Patients with at least 1 adverse event | 218 (43.1) | 235 (54.0) |
| Infections and infestations | 57 (11.3) | 94 (21.6) |
| Upper respiratory tract infection | 10 (2.0) | 21 (4.8) |
| Nasopharyngitis | 3 (0.6) | 14 (3.2) |
| Urinary tract infection | 11 (2.2) | 13 (3.0) |
| Gastrointestinal disorders | 91 (18.0) | 77 (17.7) |
| Nausea | 52 (10.3) | 36 (8.3) |
| Vomiting | 12 (2.4) | 22 (5.1) |
| Constipation | 30 (5.9) | 17 (3.9) |
| Diarrhea | 11 (2.2) | 15 (3.4) |
| Nervous system disorders | 48 (9.5) | 46 (10.6) |
| Headache | 18 (3.6) | 19 (4.4) |
| Musculoskeletal and connective tissue disorders | 24 (4.7) | 49 (11.3) |
| Back pain | 4 (0.8) | 16 (3.7) |
| Injury, poisoning, and procedural complications | 20 (4.0) | 49 (11.3) |
| Falls | 6 (1.2) | 13 (3.0) |