Table 5.
Incidence of treatment-emergent adverse events reported by ≥5 % of patients in either treatment group (safety population)
| System organ class TEAE |
Tapentadol ER (n = 50) |
Morphine SR (n = 50) |
|---|---|---|
| General disorders and administration-site conditions | 21 (42.0) | 20 (40.0) |
| Disease progression | 16 (32.0) | 17 (34.0) |
| Malaise | 4 (8.0) | 0 |
| Pyrexia | 3 (6.0) | 4 (8.0) |
| Nervous system disorders | 18 (36.0) | 17 (34.0) |
| Somnolence | 8 (16.0) | 10 (20.0) |
| Headache | 1 (2.0) | 4 (8.0) |
| Gastrointestinal disorders | 19 (38.0) | 27 (54.0) |
| Nausea | 7 (14.0) | 7 (14.0) |
| Constipation | 6 (12.0) | 10 (20.0) |
| Vomiting | 3 (6.0) | 13 (26.0) |
| Diarrhea | 3 (6.0) | 4 (8.0) |
| Blood and lymphatic system disorders | 8 (16.0) | 3 (6.0) |
| Anemia | 4 (8.0) | 1 (2.0) |
| Psychiatric disorders | 5 (10.0) | 1 (2.0) |
| Insomnia | 4 (8.0) | 0 |
| Injury, poisoning, and procedural complications | 4 (8.0) | 4 (8.0) |
| Fall | 4 (8.0) | 1 (2.0) |
| Investigations | 8 (16.0) | 13 (26.0) |
| γ-Glutamyltransferase increased | 1 (2.0) | 4 (8.0) |
| Skin and subcutaneous tissue disorders | 8 (16.0) | 10 (20.0) |
| Pruritus | 1 (2.0) | 4 (8.0) |
Values are expressed as n (%)
ER extended release, SR sustained release, TEAE treatment-emergent adverse event