TEAEs reported by ≥5% of patients in the DB maintenance phase (DB safety population)a
| AE, n (%) | Placebo (n = 152) | Tapentadol ER (n = 166) |
|---|---|---|
| Any AE | 93 (61.2) | 132 (79.5) |
| Gastrointestinal disorders | ||
| Nausea | 15 (9.9) | 35 (21.1) |
| Vomiting | 7 (4.6) | 21 (12.7) |
| Diarrhea | 10 (6.6) | 11 (6.6) |
| Constipation | 0 | 9 (5.4) |
| General disorders and administration site conditions | ||
| Fatigue | 1 (0.7) | 12 (7.2) |
| Infections and infestations | ||
| Nasopharyngitis | 4 (2.6) | 9 (5.4) |
| Nervous system disorders | ||
| Dizziness | 3 (2.0) | 12 (7.2) |
| Somnolence | 1 (0.7) | 10 (6.0) |
| Headache | 8 (5.3) | 4 (2.4) |
| Psychiatric disorders | ||
| Insomnia | 4 (2.6) | 9 (5.4) |
| Anxiety | 8 (5.3) | 8 (4.8) |
DB, double blind.
↵aPatients could report more than one AE.