Table 7.
All adverse events reported by ≥2% of patients by age group (treated patients)—active-comparator trials
| Preferred term | Fentanyl ITS | Morphine IV PCA | ||||||
|---|---|---|---|---|---|---|---|---|
| <65 years (N = 901) [n (%)] | 65–74 years (N = 250) [n (%)] | 75–84 years (N = 125) [n (%)] | ≥85 years (N = 12) [n (%)] | <65 years (N = 931) [n (%)] | 65–74 years (N = 234) [n (%)] | 75–84 years (N = 135) [n (%)] | ≥85 years (N = 13) [n (%)] | |
| Nausea | 399 (44.3) | 81 (32.4) | 37 (29.6) | 2 (16.7) | 416 (44.7) | 96 (41.0) | 64 (47.4) | 8 (61.5) |
| Pyrexia | 169 (18.8) | 51 (20.4) | 15 (12.0) | 2 (16.7) | 152 (16.3) | 49 (20.9) | 20 (14.8) | 1 (7.7) |
| Application-site erythema | 152 (16.9) | 23 (9.2) | 4 (3.2) | 1 (8.3) | 0 | 0 | 0 | 0 |
| Vomiting | 128 (14.2) | 25 (10.0) | 12 (9.6) | 2 (16.7) | 113 (12.1) | 31 (13.2) | 16 (11.9) | 3 (23.1) |
| Headache | 106 (11.8) | 7 (2.8) | 7 (5.6) | 0 | 66 (7.1) | 9 (3.8) | 2 (1.5) | 0 |
| Pruritus | 61 (6.8) | 8 (3.2) | 1 (0.8) | 1 (8.3) | 106 (11.4) | 15 (6.4) | 3 (2.2) | 0 |
| Dizziness | 53 (5.9) | 5 (2.0) | 5 (4.0) | 0 | 49 (5.3) | 9 (3.8) | 4 (3.0) | 0 |
| Application-site pruritus | 41 (4.6) | 4 (1.6) | 1 (0.8) | 1 (8.3) | 0 | 0 | 0 | 0 |
| Application-site vesicles | 37 (4.1) | 1 (0.4) | 0 | 0 | 0 | 0 | 0 | 0 |
| Anemia | 36 (4.0) | 23 (9.2) | 17 (13.6) | 1 (8.3) | 39 (4.2) | 31 (13.2) | 16 (11.9) | 1 (7.7) |
| Hypotension | 32 (3.6) | 11 (4.4) | 5 (4.0) | 0 | 42 (4.5) | 20 (8.5) | 9 (6.7) | 1 (7.7) |
| Constipation | 29 (3.2) | 7 (2.8) | 9 (7.2) | 0 | 16 (1.7) | 11 (4.7) | 2 (1.5) | 2 (15.4) |
| Hypoxia | 28 (3.1) | 8 (3.2) | 5 (4.0) | 2 (16.7) | 33 (3.5) | 12 (5.1) | 8 (5.9) | 2 (15.4) |
| Insomnia | 28 (3.1) | 7 (2.8) | 4 (3.2) | 0 | 19 (2.0) | 10 (4.3) | 4 (3.0) | 0 |
| Abdominal pain | 23 (2.6) | 5 (2.0) | 2 (1.6) | 0 | 19 (2.0) | 3 (1.3) | 1 (0.7) | 0 |
| Urinary retention | 14 (1.6) | 5 (2.0) | 2 (1.6) | 0 | 22 (2.4) | 8 (3.4) | 4 (3.0) | 1 (7.7) |
| Tachycardia | 12 (1.3) | 4 (1.6) | 2 (1.6) | 0 | 29 (3.1) | 5 (2.1) | 3 (2.2) | 0 |
IV PCA intravenous patient-controlled analgesia