Table 3

Treatment emergent adverse events (TEAE) of special interest

Safety population
Morphine (n=142)Placebo (n=137)
Subjects with at least one special interest TEAE129 (90.8%)130 (94.9%)
Any respiratory disorder61 (43.0%)71 (51.8%)
Bronchospasm56 (39.4%)†65 (47.4%)†
Wheezing3 (2.1%)4 (2.9%)†
Any gastrointestinal disorder108 (76.1%)94 (68.6%)
Abdominal pain or discomfort10 (7.0%)5 (3.6%)
Constipation*79 (55.6%)†59 (43.1%)†
Dry mouth36 (25.4%)40 (29.2%)†
Nausea6 (4.2%)4 (2.9%)
Vomiting**53 (37.3%)32 (23.4%)†
Any cardiac disorders23 (16.2%)13 (9.5%)
Arrhythmia22 (15.5%)13 (9.5%)†
Bradycardia2 (1.4%)0 (0.0%)
Tachycardia1 (0.7%)0 (0.0%)
Vascular disorders20 (14.1%)23 (16.8%)
Flushing7 (4.9%)10 (7.3%)
Hypertension13 (9.2%)16 (11.7%)†
Any nervous system disorder105 (73.9%)95 (69.3%)
Dizziness37 (26.1%)†35 (25.5%)†
Headache29 (20.4%)†27 (19.7%)
Somnolence85 (59.9%)†70 (51.1%)
Tremor26 (18.3%)20 (14.6%)
Any psychiatric disorder56 (39.4%)53 (38.7%)
Agitation37 (26.1%)38 (27.7%)†
Delirium12 (8.5%)†10 (7.3%)†
Mood altered21 (14.8%)21 (15.3%)†
Skin disorder23 (16.2%)16 (11.7%)
Rash0 (0.0%)1 (0.7%)
Rash maculopapular0 (0.0%)1 (0.7%)
Urticaria23 (16.2%)15 (10.9%)
  • Data presented as frequency (percentage); *p=0.037 for difference between the groups; **p=0.012 for difference between groups.

  • †At least one participant experienced this TEAE with NCI-CTCAE severity grade 3, 4 or 5. The safety population included all participants who received at least one dose of study medication.

  • NCI-CTCAE, National Institutes of Health Common Terminology Criteria for Adverse Events.