Table 3.
Summary of treatment-emergent adverse events
| Opioid RM
|
No opioid RM
|
Total | ||||
|---|---|---|---|---|---|---|
| Placebo (n=183) |
DPLFC 25 mg (n=101) |
Placebo (n=17) |
DPLFC 25 mg (n=100) |
Placebo (N=200) |
DPLFC 25 mg (N=201) |
|
| Patients with ≥1 AE | 102 (55.7) | 41 (40.6) | 5 (29.4) | 26 (26.0) | 107 (53.5) | 67 (33.3) |
| Patients with ≥1 SAE | 2 (1.1) | 0 | 0 | 0 | 2 (1.0) | 0 |
| Most common AEs*, n (%) | ||||||
| Nausea | 44 (24.0) | 21 (20.8) | 1 (5.9) | 5 (5.0) | 45 (22.5) | 26 (12.9) |
| Vomiting | 16 (8.7) | 11 (10.9) | 1 (5.9) | 1 (1.0) | 17 (8.5) | 12 (6.0) |
| Headache | 15 (8.2) | 10 (9.9) | 1 (5.9) | 3 (3.0) | 16 (8.0) | 13 (6.5) |
| Dizziness | 11 (6.0) | 6 (5.9) | 1 (5.9) | 1 (1.0) | 12 (6.0) | 7 (3.5) |
| Constipation | 7 (3.8) | 6 (5.9) | 0 | 2 (2.0) | 7 (3.5) | 8 (4.0) |
| Abdominal pain | 2 (1.1) | 4 (4.0) | 1 (5.9) | 5 (5.0) | 3 (1.5) | 9 (4.5) |
| Pyrexia | 8 (4.4) | 0 | 0 | 0 | 8 (4.0) | 0 |
| Somnolence | 5 (2.7) | 4 (4.0) | 0 | 2 (2.0) | 5 (2.5) | 6 (3.0) |
| Diarrhea | 5 (2.7) | 0 | 0 | 3 (3.0) | 5 (2.5) | 3 (1.5) |
| Pruritus | 5 (2.7) | 1 (1.0) | 0 | 2 (2.0) | 5 (2.5) | 3 (1.5) |
| Hyperhidrosis | 4 (2.2) | 1 (1.0) | 0 | 0 | 4 (2.0) | 1 (0.5) |
| Anxiety | 4 (2.2) | 1 (1.0) | 0 | 0 | 4 (2.0) | 1 (0.5) |
Notes:
*
Occurring in ≥2% of patients.
Abbreviations: AE, adverse event; SAE, serious adverse event; RM, rescue medication; DPLFC, diclofenac potassium liquid-filled capsule.