Table 3.
Treatment-emergent adverse events—safety analysis set (5% in either group).
| Degarelix (N=142) | Goserelin (N=141) | |
|---|---|---|
| All AEs, n (%) | 108 (76.1%) | 83 (58.9%) |
| Cardiac disorders | 11 (7.7%) | 15 (10.6%) |
| Gastrointestinal disorders | 11 (7.7%) | 12 (8.5%) |
| General disorders and administration site conditions | 74 (52.1%) | 12 (8.5%) |
| Infections and infestations | 27 (19.0%) | 20 (14.2%) |
| Procedural complications investigations | 18 (12.7%) | 29 (20.6%) |
| Musculoskeletal and connective tissue disorders | 11 (7.7%) | 15 (10.6%) |
| Nervous system disorders | 6 (4.2%) | 7 (5.0%) |
| Renal and urinary disorders | 9 (6.3%) | 11 (7.8%) |
| Skin and subcutaneous tissue | 10 (7.0%) | 4 (2.8%) |
| Vascular disorders | 18 (12.7%) | 18 (12.8%) |
| Any injection site reactions (initiation dose) | 49 (35.0%) | 1 (0.7%) |
| Any injection site reactions (maintenance dose) | 41 (29.0%) | 1 (0.7%) |
AEs, adverse events.