Table 4.
Summary of AEs
| EU (n = 684) | NA (n = 395) | |||||||
|---|---|---|---|---|---|---|---|---|
| Enzalutamide (n = 461) | Placebo (n = 223) | Enzalutamide (n = 263) | Placebo (n = 132) | |||||
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| AE | % of patients | |||||||
| ≥1 AE | 97.8 | 45.3 | 98.2 | 50.7 | 98.5 | 46.4 | 98.5 | 58.3 |
| Any serious AE | 34.1 | 28.6 | 39.5 | 33.2 | 31.2 | 27.0 | 36.4 | 34.1 |
| Discontinuation due to AE | 6.1 | 3.5 | 8.1 | 5.4 | 10.3 | 6.5 | 13.6 | 10.6 |
| AE leading to death | 2.6 | 2.6 | 4.0 | 4.0 | 3.0 | 3.0 | 3.0 | 3.0 |
| AE of interest | ||||||||
| Any cardiac disorder | 5.6 | 1.1 | 5.4 | 0.9 | 7.2 | 0.8 | 12.1 | 3.8 |
| Myocardial infarction | 0.2 | 0.2 | 0.0 | 0.0 | 0.4 | 0.4 | 1.5 | 1.5 |
| Abnormality on liver function testing | 1.1 | 0.2 | 0.4 | 0.0 | 1.1 | 0.8 | 3.0 | 1.5 |
| Seizure* | 0.87 | 0.87 | 0.0 | 0.0 | 0.38 | 0.38 | 0.0 | 0.0 |
*Events of seizure were reported in three EU patients and one NA patient at the pre-specified interim analysis. In the AFFIRM manuscript, these four events and one event in an Australian patient were included for a total of five patients 6. Subsequently, one additional patient (EU) was identified with an event term ‘vasovagal syndrome’ with features suggestive of seizure. Thus, five patients with an event of seizure are included in these data for EU and NA patients. The overall incidence of seizure in the AFFIRM analysis population was ≤0.9%.