Table 3.

Treatment-emergent adverse events (safety population)

Treatment-emergent adverse events*	Grade ≥3 Patients (%) (n=61)	Prior use of abiraterone
		No (n=35)	Yes (n=25)
Patients with TEAEs	42 (68.9)	21 (60.0)	20 (80.0)†
Hematological TEAEs
Neutropenia	9 (14.8)	4 (11.4)	5 (20.0)
Anemia	6 (9.8)	3 (8.6)	3 (12.0)
Febrile neutropenia	6 (9.8)	3 8.6)	3 (12.0)
White blood cell count decreased	3 (4.9)	2 (5.7)	1 (4.0)
Non-hematological TEAEs
Fatigue	6 (9.8)	3 (8.6)	3 (12.0)
Diarrhea	5 (8.2)	3 (8.6)	2 (8.0)
Back pain	3 (4.9)	0 (0.0)	3 (12.0)
Dehydration	4 (6.6)	1 (2.9)	3 (12.0)
Spinal cord compression	4 (6.6)	2 (5.7)	1 (4.0)
Nausea	3 (4.9)	2 (5.7)	1 (4.0)
Vomiting	3 (4.9)	2 (5.7)	1 (4.0)
Cellulitis	3 (4.9)	2 (5.7)	1 (4.0)
Sepsis	3 (4.9)	2 (5.7)	1 (4.0)
Pain in extremity	1(1.6)	1 (2.9)	0 (0.0)
Asthenia	2 (3.3)	2 (5.7)	0 (0.0)
Pulmonary embolism	2 (3.3)	1 (2.9)	1 (4.0)
Renal failure acute	2 (3.3)	0 (0.0)	2 (8.0)

^*TEAEs with a frequency ≥2% for Grade ≥3 adverse events. TEAEs are classified based on the frequency of grade ≥3 TEAEs.

^†p=0.16. Significance of specific hematological and nonhematological TEAEs was not assessed as analyses would be underpowered due to the small number of events in each group. TEAE: treatment-emergent adverse events.