Table 1.
Proportion of patients receiving ARIs who experienced AEs
| All Patients (N = 699) |
Apalutamidea (N = 368) |
Enzalutamidea (N = 333) |
|
|---|---|---|---|
| Any AE, proportion (95% CI) | 75.1% (71.8, 78.2%) | 72.0% (67.2, 76.4%) | 78.7% (74.0, 82.7%) |
| Adverse events that occurred in ≥5% of patients in either group, proportion (95% CI) | |||
| Hot flush | 13.9% (11.5, 16.6%) | 14.1% (10.9, 18.1%) | 13.5% (10.3, 17.6%) |
| Arthralgia | 13.6% (11.2, 16.3%) | 14.4% (11.2, 18.4%) | 12.9% (9.7, 16.9%) |
| Decreased appetite | 9.4% (7.5, 11.8%) | 6.5% (4.4, 9.5%) | 12.9% (9.7, 16.9%) |
| Diarrhea | 6.7% (5.1, 8.8%) | 5.4% (3.5, 8.2%) | 8.1% (5.6, 11.5%) |
| Dizziness/vertigo | 5.9% (4.4, 7.9%) | 5.2% (3.3, 7.9%) | 6.6% (4.4, 9.8%) |
| Peripheral edema | 4.0% (2.8, 5.7%) | 3.0% (1.7, 5.3%) | 5.1% (3.2, 8.0%) |
| Adverse events of special interest, proportion (95% CI)b | |||
| Fatigue/asthenia | 34.3% (30.9, 37.9%) | 30.2% (25.7, 35.0%) | 38.7% (33.7, 44.1%) |
| Hypertension | 7.2% (5.5, 9.3%) | 7.3% (5.1, 10.5%) | 6.9% (4.6, 10.2%) |
| Mental impairment disorderc | 6.4% (4.8, 8.5%) | 5.4% (3.5, 8.2%) | 7.5% (5.1, 10.8%) |
| Rash | 4.7% (3.4, 6.6%) | 6.3% (4.2, 9.2%) | 3.0% (1.6, 5.4%) |
| Cardiovascular events | 3.1% (2.1, 4.7%) | 2.4% (1.3, 4.6%) | 3.9% (2.3, 6.6%) |
| Headache | 3.1% (2.1, 4.7%) | 3.5% (2.1, 5.9%) | 2.7% (1.4, 5.1%) |
| Falls | 2.3% (1.4, 3.7%) | 1.6% (0.7, 3.5%) | 3.0% (1.6, 5.4%) |
| Fracture | 1.1% (0.6, 2.2%) | 1.9% (0.9, 3.9%) | 0.3% (0.1, 1.7%) |
| Weight decrease | 1.6% (0.9, 2.8%) | 1.4% (0.6, 3.1%) | 1.8% (0.8, 3.9%) |
| Hypothyroidism | 1.1% (0.6, 2.2%) | 1.4% (0.6, 3.1%) | 0.9% (0.3, 2.6%) |
| Seizure/convulsion | 0.7% (0.3, 1.7%) | 0.3% (0.0, 1.5%) | 1.2% (0.5, 3.0%) |
| Hepatic impairment | 0.4% (0.1, 1.3%) | 0.0% (0.0, 1.0%) | 0.9% (0.3, 2.6%) |
Abbreviations: AE Adverse event; ARI Androgen receptor inhibitor; CI Confidence interval
aTwo patients received both apalutamide and enzalutamide. The specific AEs have been attributed to the respective therapy cohort, and therefore the Ns add to > 100%
bNo patients experienced neutropenia, cerebral ischemia, heart failure, or posterior reversible encephalopathy syndrome
cIncluded cognitive and attention disorders, memory impairment, mental and cognitive changes, and mental impairment disorder