Table 3.
Number (%) of patients with treatment-emergent adverse events occurring in >5% of patients (safety population) from any prior opioid type
| TD fentanyl (n=77) |
IR hydrocodone (n=164) |
IR hydromorphone (n=22) |
IR oxycodone (n=160) |
IR morphine (n=53) |
Methadone (n=64) |
ER oxycodone (n=107) |
ER oxymorphone (n=25) |
Excluded opioid/unclassif (n=12) |
Total (N=684) |
|
|---|---|---|---|---|---|---|---|---|---|---|
| Pts with ≥1 TEAE | 47 (61.0) | 90 (54.9) | 8 (36.4) | 81 (50.6) | 30 (56.6) | 28 (43.8) | 45 (42.1) | 12 (48.0) | 2 (16.7) | 343 (50.1) |
| Cardiac disorders | ||||||||||
| Dyspnea | 1 (1.3) | 0 | 0 | 3 (1.9) | 0 | 1 (1.6) | 0 | 0 | 1 (8.3) | 6 (0.9) |
| Gastrointestinal disorders | ||||||||||
| Constipation | 8 (10.4) | 26 (15.9) | 0 | 17 (10.6) | 5 (9.4) | 3 (4.7) | 14 (13.1) | 3 (12.0) | 0 | 76 (11.1) |
| Nausea | 7 (9.1) | 13 (7.9) | 2 (9.1) | 13 (8.1) | 8 (15.1) | 3 (4.7) | 7 (6.5) | 3 (12.0) | 1 (8.3) | 57 (8.3) |
| Vomiting | 4 (5.2) | 11 (6.7) | 1 (4.5) | 7 (4.4) | 2 (3.8) | 4 (6.3) | 3 (2.8) | 2 (8.0) | 0 | 34 (5.0) |
| General disorders and administration site conditions | ||||||||||
| Fatigue | 4 (5.2) | 3 (1.8) | 0 | 8 (5.0) | 2 (3.8) | 0 | 2 (1.9) | 1 (4.0) | 0 | 20 (2.9) |
| Nervous system disorders | ||||||||||
| Dizziness | 0 | 7 (4.3) | 0 | 2 (1.3) | 2 (3.8) | 0 | 6 (5.6) | 1 (4.0) | 0 | 18 (2.6) |
| Headache | 4 (5.2) | 5 (3.0) | 2 (9.1) | 8 (5.0) | 6 (11.3) | 5 (7.8) | 5 (4.7) | 1 (4.0) | 1 (8.3) | 37 (5.4) |
| Somnolence | 3 (3.9) | 8 (4.9) | 2 (9.1) | 6 (3.8) | 3 (5.7) | 1 (1.6) | 2 (1.9) | 0 | 0 | 25 (3.7) |
| Tremor | 1 (1.3) | 0 | 1 (4.5) | 0 | 1 (1.9) | 0 | 0 | 0 | 1 (8.3) | 4 (0.6) |
| Psychiatric disorders | ||||||||||
| Anxiety | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.9) | 0 | 1 (8.3) | 2 (0.3) |
| Skin and subcutaneous tissue disorders | ||||||||||
| Rash | 1 (1.3) | 1 (0.6) | 1 (4.5) | 1 (0.6) | 1 (1.9) | 0 | 1 (0.9) | 2 (8.0) | 0 | 8 (1.2) |
Note: An adverse event is defined as treatment emergent if it has a start date/time at any point after the patient filled the initial MSN prescription.
Abbreviations: ER, extended-release; IR, immediate-release; MSN, extended-release morphine sulfate surrounding sequestered naltrexone hydrochloride; Pts, patients; TD, transdermal; TEAE, treatment-emergent adverse event; Unclassif, unclassified.