Table 3.
Treatment-emergent adverse events (reported in ≥10.0% of patients)
| Adverse event, n (%) | Combination therapya (n = 22)
|
Post-docetaxel enzalutamideb (n = 21)
|
||||
|---|---|---|---|---|---|---|
| All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | |
| Blood and lymphatic system disorders | ||||||
| Neutropenia | 19 (86.4) | 2 (9.1) | 17 (77.3) | 1 (4.8) | 1 (4.8) | 0 |
| Febrile neutropenia | 4 (18.2) | 3 (13.6) | 1 (4.5) | 0 | 0 | 0 |
| Anemia | 4 (18.2) | 1 (4.5) | 0 | 1 (4.8) | 0 | 0 |
| General disorders and administration site conditions | ||||||
| Fatigue | 17 (77.3) | 0 | 0 | 4 (19.0) | 0 | 0 |
| Pain | 4 (18.2) | 0 | 0 | 0 | 0 | 0 |
| Asthenia | 3 (13.6) | 0 | 0 | 2 (9.5) | 0 | 0 |
| Nervous system disorders | ||||||
| Neuropathy peripheral | 9 (40.9) | 0 | 0 | 1 (4.8) | 0 | 0 |
| Peripheral sensory neuropathy | 7 (31.8) | 1 (4.5) | 0 | 3 (14.3) | 0 | 0 |
| Dysgeusia | 5 (22.7) | 0 | 0 | 1 (4.8) | 0 | 0 |
| Dizziness | 4 (18.2) | 0 | 0 | 0 | 0 | 0 |
| Peripheral motor neuropathy | 3 (13.6) | 0 | 0 | 1 (4.8) | 0 | 0 |
| Headache | 3 (13.6) | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal disorders | ||||||
| Nausea | 8 (36.4) | 0 | 0 | 0 | 0 | 0 |
| Constipation | 7 (31.8) | 0 | 0 | 5 (23.8) | 0 | 0 |
| Diarrhea | 7 (31.8) | 0 | 0 | 0 | 0 | 0 |
| Dyspepsia | 4 (18.2) | 0 | 0 | 0 | 0 | 0 |
| Abdominal pain | 3 (13.6) | 0 | 0 | 1 (4.8) | 0 | 0 |
| Stomatitis | 3 (13.6) | 0 | 0 | 0 | 0 | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 6 (27.3) | 0 | 0 | 4 (19.0) | 0 | 0 |
| Dehydration | 3 (13.6) | 0 | 0 | 1 (4.8) | 1 (4.8) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 6 (27.3) | 0 | 0 | 3 (14.3) | 1 (4.8) | 0 |
| Back pain | 6 (27.3) | 0 | 0 | 3 (14.3) | 0 | 0 |
| Musculoskeletal pain | 3 (13.6) | 0 | 0 | 4 (19.0) | 1 (4.8) | 0 |
| Musculoskeletal chest pain | 3 (13.6) | 0 | 0 | 2 (9.5) | 0 | 0 |
| Pain in extremity | 3 (13.6) | 0 | 0 | 0 | 0 | 0 |
| Flank pain | 3 (13.6) | 1 (4.5) | 0 | 1 (4.8) | 1 (4.8) | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Dyspnea | 6 (27.3) | 0 | 0 | 1 (4.8) | 0 | 0 |
| Dyspnea exertional | 4 (18.2) | 0 | 0 | 0 | 0 | 0 |
| Skin and subcutaneous disorders | ||||||
| Alopecia | 6 (27.3) | 0 | 0 | 0 | 0 | 0 |
| Rash | 3 (13.6) | 0 | 0 | 2 (9.5) | 0 | 0 |
| Nail disorder | 3 (13.6) | 0 | 0 | 1 (4.8) | 0 | 0 |
| Eye disorders | ||||||
| Lacrimation increased | 5 (22.7) | 0 | 0 | 1 (4.8) | 0 | 0 |
| Investigations | ||||||
| White blood cell count decreased | 4 (18.2) | 3 (13.6) | 1 (4.5) | 1 (4.8) | 0 | 0 |
| Renal and urinary disorders | ||||||
| Pollakiuria | 3 (13.6) | 0 | 0 | 1 (4.8) | 0 | 0 |
| Psychiatric disorders | ||||||
| Insomnia | 3 (13.6) | 0 | 0 | 0 | 0 | 0 |
NOTE: Percentages are based on the number of patients in the safety population (N).
a
Starting the day of each docetaxel infusion to 30 days after the infusion.
b
From day 1 to 30 days after last enzalutamide dose, excluding the combination therapy window.