Table 2.
Adverse events occurring in ≥5% of patients
| Open-label titration period – safety analysis set
|
Double-blind treatment period – full analysis set
|
|||
|---|---|---|---|---|
| Opioid-naïve (n=189) | Opioid-experienced (n=200) | Placebo (n=147) | HydrocodoneER (n=146) | |
| Patients with ≥1 AE, n (%) | 111 (59) | 116 (58) | 91 (62) | 93 (64) |
| AEs with incidence ≥5%, n (%) | ||||
| Nausea | 39 (21) | 31 (16) | 9 (6) | 19 (13) |
| Headache | 17 (9) | 26 (13) | 8 (5) | 10 (7) |
| Back pain | 0 | 3 (2) | 7 (5) | 1 (<1) |
| Constipation | 28 (15) | 27 (14) | 7 (5) | 19 (13) |
| URTI | 3 (2) | 1 (<1) | 7 (5) | 7 (5) |
| Vomiting | 15 (8) | 10 (5) | 5 (3) | 9 (6) |
| Dry mouth | 9 (5) | 6 (3) | 2 (1) | 2 (1) |
| Fatigue | 8 (4) | 10 (5) | 2 (1) | 1 (<1) |
| Dizziness | 14 (7) | 8 (4) | 1 (<1) | 3 (2) |
| Pruritus | 16 (8) | 4 (2) | 1 (<1) | 3 (2) |
| Somnolence | 23 (12) | 22 (11) | 1 (<1) | 3 (2) |
Note: All values are number of patients (percentage of patients).
Abbreviations: AE, adverse event; ER, extended release; URTI, upper respiratory tract infection.