Treatment emergent adverse events (TEAE) of special interest
| Safety population | |||
| Morphine (n=142) | Placebo (n=137) | ||
| Subjects with at least one special interest TEAE | 129 (90.8%) | 130 (94.9%) | |
| Any respiratory disorder | 61 (43.0%) | 71 (51.8%) | |
| Bronchospasm | 56 (39.4%)† | 65 (47.4%)† | |
| Wheezing | 3 (2.1%) | 4 (2.9%)† | |
| Any gastrointestinal disorder | 108 (76.1%) | 94 (68.6%) | |
| Abdominal pain or discomfort | 10 (7.0%) | 5 (3.6%) | |
| Constipation* | 79 (55.6%)† | 59 (43.1%)† | |
| Dry mouth | 36 (25.4%) | 40 (29.2%)† | |
| Nausea | 6 (4.2%) | 4 (2.9%) | |
| Vomiting** | 53 (37.3%) | 32 (23.4%)† | |
| Any cardiac disorders | 23 (16.2%) | 13 (9.5%) | |
| Arrhythmia | 22 (15.5%) | 13 (9.5%)† | |
| Bradycardia | 2 (1.4%) | 0 (0.0%) | |
| Tachycardia | 1 (0.7%) | 0 (0.0%) | |
| Vascular disorders | 20 (14.1%) | 23 (16.8%) | |
| Flushing | 7 (4.9%) | 10 (7.3%) | |
| Hypertension | 13 (9.2%) | 16 (11.7%)† | |
| Any nervous system disorder | 105 (73.9%) | 95 (69.3%) | |
| Dizziness | 37 (26.1%)† | 35 (25.5%)† | |
| Headache | 29 (20.4%)† | 27 (19.7%) | |
| Somnolence | 85 (59.9%)† | 70 (51.1%) | |
| Tremor | 26 (18.3%) | 20 (14.6%) | |
| Any psychiatric disorder | 56 (39.4%) | 53 (38.7%) | |
| Agitation | 37 (26.1%) | 38 (27.7%)† | |
| Delirium | 12 (8.5%)† | 10 (7.3%)† | |
| Mood altered | 21 (14.8%) | 21 (15.3%)† | |
| Skin disorder | 23 (16.2%) | 16 (11.7%) | |
| Rash | 0 (0.0%) | 1 (0.7%) | |
| Rash maculopapular | 0 (0.0%) | 1 (0.7%) | |
| Urticaria | 23 (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.