Table 3.
Adverse Events.
| Event | Enzalutamide Group (N = 930) | Placebo Group (N = 465) | ||
|---|---|---|---|---|
| All Grades | Grade ≥3 | All Grades | Grade ≥3 | |
| number of patients (percent) | ||||
| Any adverse event | 808 (87) | 292 (31) | 360 (77) | 109 (23) |
| Any serious adverse event* | 226 (24) | — | 85 (18) | — |
| Adverse event leading to discontinuation of trial regimen | 87 (9) | — | 28 (6) | — |
| Adverse event leading to death | 32 (3) | — | 3 (1) | — |
| Most common adverse events, occurring in ≥5% of patients† | ||||
| Fatigue | 303 (33) | 27 (3) | 64 (14) | 3 (1) |
| Hot flush | 121 (13) | 1 (<1) | 36 (8) | 0 |
| Nausea | 106 (11) | 3 (<1) | 40 (9) | 0 |
| Diarrhea | 91 (10) | 3 (<1) | 45 (10) | 2 (<1) |
| Hypertension | 111 (12) | 43 (5) | 24 (5) | 10 (2) |
| Fall | 106 (11) | 12 (1) | 19 (4) | 3 (1) |
| Constipation | 85 (9) | 2 (<1) | 32 (7) | 2 (<1) |
| Dizziness | 91 (10) | 4 (<1) | 20 (4) | 0 |
| Arthralgia | 78 (8) | 1 (<1) | 32 (7) | 1 (<1) |
| Asthenia | 82 (9) | 11 (1) | 28 (6) | 1 (<1) |
| Decreased appetite | 89 (10) | 2 (<1) | 18 (4) | 1 (<1) |
| Back pain | 73 (8) | 2 (<1) | 33 (7) | 1 (<1) |
| Headache | 85 (9) | 2 (<1) | 21 (5) | 0 |
| Hematuria | 62 (7) | 16 (2) | 36 (8) | 13 (3) |
| Urinary tract infection | 38 (4) | 7 (1) | 30 (6) | 3 (1) |
| Weight loss | 55 (6) | 2 (<1) | 7 (2) | 0 |
| Urinary retention | 20 (2) | 4 (<1) | 28 (6) | 5 (1) |
| Adverse events of special interest | ||||
| Hypertension‡ | 114 (12) | 43 (5) | 25 (5) | 11 (2) |
| Major adverse cardiovascular event§ | 48 (5) | 34 (4) | 13 (3) | 8 (2) |
| Mental impairment disorders¶ | 48 (5) | 1 (<1) | 9 (2) | 0 |
| Hepatic impairment | 11 (1) | 5 (1) | 9 (2) | 2 (<1) |
| Neutropenia | 9 (1) | 5 (1) | 1 (<1) | 1 (<1) |
| Convulsion | 3 (<1) | 2 (<1) | 0 | 0 |
| Posterior reversible encephalopathy syndrome | 0 | 0 | 0 | 0 |
Serious adverse events were events that resulted in death, were life-threatening, resulted in or prolonged hospitalization, resulted in inability to conduct normal life functions, or led to a congenital anomaly or birth defect. A full definition is provided in the protocol.
Listed in descending order are the adverse events that were reported in at least 5% of the patients in either group.
This adverse event includes increased blood pressure.
This adverse event includes acute myocardial infarction, hemorrhagic cerebrovascular conditions, ischemic cerebrovascular conditions, and heart failure.
This adverse event includes memory impairment, disturbance in attention, cognitive disorders, amnesia, Alzheimer’s disease, senile dementia, mental impairment, and vascular dementia.