Table 5.
Most common (>5% in any treatment group) TEAEs during the treatment phase (safety sample)
| System organ class Preferred term TEAE, n (%) | Oxycodone HCl 40/0 mg (n = 48) | Oxycodone HCl 80/0 mg (n = 47) | Oxycodone HCl-niacin 40/240 mg (n = 48) | Oxycodone HCl-niacin 80/480 mg (n = 49) | Placebo (n = 48) |
|---|---|---|---|---|---|
| Participants with any TEAE | 37 (77) | 46 (98) | 47 (98) | 49 (100) | 6 (13) |
| Skin and subcutaneous tissue disorders | 29 (60) | 35 (74) | 43 (90) | 48 (98) | 3 (6) |
| Pruritus | 29 (60) | 34 (72) | 36 (75) | 39 (80) | 2 (4) |
| Skin burning sensation | 0 | 1 (2) | 24 (50) | 40 (82) | 1 (2) |
| Skin warm | 1 (2) | 3 (6) | 15 (31) | 9 (18) | 0 |
| Nervous system disorders | 24 (50) | 30 (64) | 18 (38) | 29 (59) | 1 (2) |
| Dizziness | 6 (13) | 9 (19) | 4 (8) | 8 (16) | 0 |
| Headache | 2 (4) | 7 (15) | 3 (6) | 6 (12) | 0 |
| Somnolence | 17 (35) | 18 (38) | 13 (27) | 22 (45) | 1 (2) |
| Vascular disorders | 0 | 3 (6) | 43 (90) | 46 (94) | 0 |
| Flushing | 0 | 3 (6) | 43 (90) | 46 (94) | 0 |
| Gastrointestinal disorders | 8 (17) | 24 (51) | 12 (25) | 22 (45) | 1 (2) |
| Constipation | 2 (4) | 6 (13) | 5 (10) | 3 (6) | 0 |
| Nausea | 4 (8) | 18 (38) | 5 (10) | 17 (35) | 0 |
| Vomiting | 1 (2) | 11 (23) | 4 (8) | 8 (16) | 0 |
| General disorders and administration site conditions | 3 (6) | 7 (15) | 4 (8) | 3 (6) | 0 |
| Chills | 0 | 0 | 1 (2) | 3 (6) | 0 |
| Feeling hot | 1 (2) | 3 (6) | 1 (2) | 0 | 0 |
| Irritability | 2 (4) | 4 (9) | 1 (2) | 0 | 0 |
| Investigations | 1 (2) | 10 (21) | 0 | 4 (8) | 0 |
| Oxygen saturation decreased | 1 (2) | 10 (21) | 0 | 4 (8) | 0 |
| Renal and urinary disorders | 2 (4) | 4 (9) | 1 (2) | 0 | 0 |
| Dysuria | 2 (4) | 4 (9) | 1 (2) | 0 | 0 |
Abbreviation: TEAE, treatment-emergent adverse event.