Randomized, Open-Label Phase 2 Study of Apalutamide plus Androgen Deprivation Therapy versus Apalutamide Monotherapy versus Androgen Deprivation Monotherapy in Patients with Biochemically Recurrent Prostate Cancer
Table 5
Summary of treatment-emergent adverse events in the safety population.
Apalutamide + ADT (n = 31)
Apalutamide (n = 29)
ADT (n = 29)
Any treatment-related AE
31 (100%)
29 (100%)
28 (96.6%)
Serious AE
5 (16.1%)
0
3 (10.3%)
AE leading to death
0
0
1 (3.4%)
AE leading to discontinuation of study agent or termination of study participation
0
2 (6.9%)
1 (3.4%)
Grade ≥3 AEs
9 (29.0%)
5 (17.2%)
4 (13.8%)
Drug-related grade ≥3 AEs
2 (6.5%)
2 (6.9%)
0
Most frequently reported AEs occurring in ≥25% of patients
Fatigue
24 (77.4%)
19 (65.5%)
22 (75.9%)
Hot flush
26 (83.9%)
9 (31.0%)
25 (86.2%)
Arthralgia
7 (22.6%)
8 (27.6%)
5 (17.2%)
Gynecomastia
1 (3.2%)
12 (41.4%)
3 (10.3%)
Nipple pain
0
12 (41.4%)
0
Insomnia
10 (32.3%)
1 (3.4%)
2 (6.9%)
AEs of special interest
11 (35.5%)
11 (37.9%)
5 (17.2%)
Rash†
6 (19.4%)
10 (34.5%)
3 (10.3%)
Fall
4 (12.9%)
1 (3.4%)
2 (6.9%)
Hypothyroidism
2 (6.5%)
1 (3.4%)
0
Fracture‡
1 (3.2%)
0
1 (3.4%)
Patient experienced a fatal event of toxic epidermal necrolysis within 30 days of the last dose of ADT; it was not considered related to the study treatment. †Grouped term; includes rash, rash pruritic, rash maculo-papular, conjunctivitis, rash generalized, rash papular, stomatitis, and toxic epidermal necrolysis. ‡Grouped term; includes fracture pain, hand fracture, rib fracture.
