Table 4.
Treatment-Related AEs Experienced by ≥ 10% of Patients in Either Treatment Arm
| AE | AD Plus Cixutumumab (n = 101) |
AD Alone (n = 104) |
||||
|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 | |
| ALT increased | 13 | 1 | 1 | 9 | 0 | 0 |
| AST increased | 11 | 1 | 1 | 10 | 0 | 0 |
| Anemia | 26 | 4 | 1 | 16 | 0 | 1 |
| Creatinine increased | 2 | 2 | 0 | 1 | 0 | 0 |
| Dry skin | 14 | 0 | 0 | 0 | 0 | 0 |
| Dysgeusia | 10 | 1 | 0 | 0 | 0 | 0 |
| Erectile dysfunction | 2 | 1 | 1 | 7 | 4 | 0 |
| Fatigue | 40 | 16 | 0 | 26 | 7 | 0 |
| Hot flashes | 31 | 5 | 1 | 43 | 13 | 1 |
| Hyperglycemia | 28 | 15 | 8 | 8 | 0 | 0 |
| Hypertension | 6 | 7 | 2 | 4 | 7 | 2 |
| Myalgia | 13 | 0 | 0 | 1 | 0 | 0 |
| Nausea | 9 | 2 | 1 | 1 | 2 | 0 |
| Neutrophil count decreased | 10 | 1 | 0 | 1 | 1 | 0 |
| Platelet count decreased | 23 | 1 | 0 | 2 | 0 | 0 |
Abbreviations: AD, androgen deprivation; AE, adverse event.