Table 4.
Summary of treatment-emergent adverse eventsa
| Placebo (n=79) | Oliceridine demand dose regimen | Morphine 1 mg regimen (n=76) | |||
|---|---|---|---|---|---|
| 0.1 mg (n=76) | 0.35 mg (n=79) | 0.5 mg (n=79) | |||
| Total number of AEs | 166 | 176 | 317 | 349 | 387 |
| Patients with ≥1 AE, n (%) | 54 (68.4) | 56 (73.7) | 68 (86.1) | 72 (91.1) | 73 (96.1) |
| Patients with ≥1 serious AE, n (%) | 0 | 0 | 0 | 0 | 0 |
| Patients with AE by severity, n (%) | |||||
| Mild | 26 (32.9) | 31 (40.8) | 30 (38.0) | 24 (30.4) | 21 (27.6) |
| Moderate | 27 (34.2) | 21 (27.6) | 34 (43.0) | 44 (55.7) | 42 (55.3) |
| Severe | 1 (1.3) | 4 (5.3) | 4 (5.1) | 4 (5.1) | 10 (13.2) |
| Patients discontinued due to AE, n (%) | 0 | 0 | 1 (1.3) | 5 (6.3) | 6 (7.9) |
| Most common AE, n (% of patients)b | |||||
| Nausea | 19 (24.1) | 27 (35.5) | 44 (55.7) | 50 (63.3) | 49 (64.5) |
| Vomiting | 5 (6.3) | 13 (17.1) | 31 (39.2) | 32 (40.5) | 38 (50.0) |
| Headache | 24 (30.4) | 19 (25.0) | 20 (25.3) | 26 (32.9) | 23 (30.3) |
| Dizziness | 8 (10.1) | 21 (27.6) | 25 (31.6) | 28 (35.4) | 26 (34.2) |
| Constipation | 9 (11.4) | 8 (10.5) | 9 (11.4) | 11 (13.9) | 13 (17.1) |
| Somnolence or sedation | 6 (7.6) | 6 (7.9) | 19 (24.1) | 12 (15.2) | 12 (15.8) |
| Pruritus or generalized pruritus | 6 (7.6) | 2 (2.6) | 13 (16.5) | 5 (6.3) | 24 (31.6) |
| Dry mouth | 1 (1.3) | 1 (1.3) | 4 (5.1) | 4 (5.1) | 12 (15.8) |
Notes:
a
Occurring during the treatment or follow-up period (7 days).
b
Occurring in ≥10% of patients in any treatment group.
Abbreviation: AE, adverse event.