Table 2

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 AE93 (61.2)132 (79.5)
Gastrointestinal disorders
 Nausea15 (9.9)35 (21.1)
 Vomiting7 (4.6)21 (12.7)
 Diarrhea10 (6.6)11 (6.6)
 Constipation09 (5.4)
General disorders and administration site conditions
 Fatigue1 (0.7)12 (7.2)
Infections and infestations
 Nasopharyngitis4 (2.6)9 (5.4)
Nervous system disorders
 Dizziness3 (2.0)12 (7.2)
 Somnolence1 (0.7)10 (6.0)
 Headache8 (5.3)4 (2.4)
Psychiatric disorders
 Insomnia4 (2.6)9 (5.4)
 Anxiety8 (5.3)8 (4.8)
  • DB, double blind.

  • aPatients could report more than one AE.