Table. Overview of Adverse Events in Men Taking Enzalutamide for Metastatic Castration-Resistant Prostate Cancer.
| Eventa | Event, No. (%)b | Total No. (%)c (N = 423) | |
|---|---|---|---|
| Grade <3 | Grade ≥3 | ||
| Adverse event | 357 (84.4) | ||
| Drug-related adverse eventd | 205 (48.5) | ||
| Serious adverse evente | 141 (33.3) | ||
| Drug-related serious adverse eventd | 29 (6.9) | ||
| Adverse event leading to permanent discontinuation of study drug | 66 (15.6) | ||
| Drug-related adverse event leading to permanent discontinuation of study drugd | 17 (4.0) | ||
| Death | 38 (9.0) | ||
| Frequently reported (≥5% of patients) treatment-emergent adverse events | |||
| Fatigue | 79 (18.7) | 8 (1.9) | 87 (20.6) |
| Asthenia | 64 (15.1) | 16 (3.8) | 80 (18.9) |
| Decreased appetite | 65 (15.4) | 5 (1.2) | 70 (16.5) |
| Anemia | 36 (8.5) | 17 (4.0) | 53 (12.5) |
| Back pain | 49 (11.6) | 4 (0.9) | 53 (12.5) |
| Nausea | 45 (10.6) | 3 (0.7) | 48 (11.3) |
| Constipation | 39 (9.2) | 2 (0.5) | 41 (9.7) |
| Diarrhea | 39 (9.2) | 1 (0.2) | 40 (9.5) |
| Arthralgia | 31 (7.3) | 0 | 31 (7.3) |
| Dyspnea | 22 (5.2) | 8 (1.9) | 30 (7.1) |
| Edema peripheral | 26 (6.1) | 2 (0.5) | 28 (6.6) |
| Vomiting | 25 (5.9) | 1 (0.2) | 26 (6.1) |
| Insomnia | 24 (5.7) | 0 | 24 (5.7) |
| Hot flash | 23 (5.4) | 0 | 23 (5.4) |
| Abdominal pain | 18 (4.3) | 5 (1.2) | 23 (5.4) |
| Pain | 16 (3.8) | 6 (1.4) | 22 (5.2) |
| Pain in extremity | 19 (4.5) | 3 (0.7) | 22 (5.2) |
| Hypertension | 13 (3.1) | 9 (2.1) | 22 (5.2) |
Preferred terms per Medical Dictionary for Regulatory Activities, Version 16.0 (http://www.meddra.org).
Grade refers to the severity of the adverse event with unique clinical descriptions of severity for each adverse event based on this general guideline: grade 1, mild adverse event; grade 2, moderate adverse event; grade 3, severe adverse event; grade 4, life-threatening or disabling adverse event; and grade 5, death related to adverse event.
All enrolled patients who took at least 1 dose of study drug and for whom any data were reported after the first dose of study drug (safety analysis set).
Possible or probable, as assessed by the investigator, or records where relationship was missing.
An adverse event was considered serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization, or a medically important event.