Table 1.
Summary of the most common AEs reported in the clinical trials.
| AEs | PLC Ntotal, NAE (%) |
Oxycodone Ntotal, NAE (%) |
Oxymorphone Ntotal, NAE (%) |
Tramadol Ntotal, NAE (%) |
|---|---|---|---|---|
| Digestive system | ||||
| • Nausea | 2505, 206 (8.22) | 1566, 518 (33.1) | 674, 277 (41.1) | 3175, 642 (20.2) |
| • Constipation | 2168, 104 (4.80) | 1224, 332 (27.1) | 674, 158 (23.2) | 3175, 508 (16.0) |
| • Vomiting | 2291, 47 (2.05) | 1566, 267 (17.1) | 674, 150 (22.3) | 2743, 219 (7.98) |
| • Diarrhea | 1464, 67 (4.58) | 1055, 69 (6.54) | 432, 11 (2.55) | 1853, 105 (5.67) |
| Central nervous system | ||||
| • Dizziness | 2505, 129 (5.15) | 1441, 330 (22.9) | 674, 144 (21.3) | 3175, 522 (16.4) |
| • Somnolence | 2505, 89 (3.55) | 1566, 305 (19.5) | 674, 129 (19.1) | 3175, 326 (10.3) |
| • Headache | 2101, 221 (10.5) | 1495, 190 (12.7) | 674, 63 (9.35) | 2590, 256 (9.88) |
| • Insomnia | 786, 22 (2.80) | 310, 21 (6.77) | no reported data. | 1740, 131 (7.53) |
| Integumentary system | ||||
| • Pruritus | 1791, 30 (1.68) | 1497, 199 (13.3) | 674, 102 (15.1) | 2417, 167 (6.91) |
| • Hyperhidrosis | 869, 6 (0.69) | 366, 23 (6.28) | 279, 21 (7.53) | 1331,60 (4.51) |
| Respiratory system | ||||
| • Xerostomia | 1396, 30 (2.15) | 1023, 103 (10.1) | 521, 52 (9.98) | 1870, 124 (6.63) |
| • Hypoventilation | 125, 0 (0) | 125, 0 (0) | 242, 0 (0) | no reported data. |
| Locomotor system | ||||
| • Fatigue | 1354, 32 (2.36) | 1156, 92 (7.96) | 432, 21 (4.86) | 1573, 86 (5.47) |
| • Asthenia | 271, 3 (1.11) | 310, 11 (3.56) | no reported data. | 211, 10 (4.88) |
Ntotal: the total number of patients involved in the clinical trials.
NAE: the total number of patient experienced AEs.
%: percentage of patients with AEs.