Table 4.
Adverse events (AEs) in Japanese prostate cancer subjects treated with degarelix (n = 117) and goserelin (n = 117): Study part 1
| Degarelix, n (%) | Goserelin, n (%) | |
|---|---|---|
| SAF, n | 117 | 117 |
| Total AEs, n (%) | 117 (100.0) | 106 (90.6) |
| Grade | ||
| 1 | 28 (23.9) | 31 (26.5) |
| 2 | 66 (56.4) | 57 (48.7) |
| 3 | 20 (17.1) | 12 (10.3) |
| 4 | 3 (2.6) | 5 (4.3) |
| 5 | 0 (0.0) | 1 (0.9) |
| ADRs | 114 (97.4) | 73 (62.4) |
| SAEs | 15 (12.8) | 16 (13.7) |
| AE incidence ≥5% (in either group), n (%) | ||
| Anemia | 3 (2.6) | 12 (10.3) |
| Constipation | 12 (10.3) | 11 (9.4) |
| Injection site erythema | 81 (69.2) | 1 (0.9) |
| Injection site induration | 77 (65.8) | 1 (0.9) |
| Injection site pain | 88 (75.2) | 7 (6.0) |
| Injection site pruritus | 17 (14.5) | 1 (0.9) |
| Injection site swelling | 26 (22.2) | 1 (0.9) |
| Injection site warmth | 7 (6.0) | 0 (0.0) |
| Malaise | 10 (8.5) | 4 (3.4) |
| Pyrexia | 18 (15.4) | 1 (0.9) |
| Nasopharyngitis | 34 (29.1) | 25 (21.4) |
| ALT increased | 7 (6.0) | 5 (4.3) |
| AST increased | 6 (5.1) | 5 (4.3) |
| Weight gain | 11 (9.4) | 7 (6.0) |
| Back pain | 6 (5.1) | 5 (4.3) |
| Hot flush | 27 (23.1) | 38 (32.5) |
| Hypertension | 7 (6.0) | 2 (1.7) |
ADR, adverse drug reaction; ALT, alanine aminotransferase; AST, aspartate aminotransferase; SAE, serious adverse event; SAF, safety analysis set.