Table 3.

AEs (≥25% in any cohort) by preferred term

Ipatasertib 400 mg + abirateroneIpatasertib 200 mg + abirateronePlacebo + abiraterone
AE, n (%)(n = 84)(n = 87)(n = 82)
Total patients with AEs83 (98.8)82 (94.3)76 (92.7)
Total patients with grade ≥3 AEs54 (64.3)44 (50.6)29 (35.4)
Total patients with SAEs36 (42.9)35 (40.2)15 (18.3)
Deaths30 (35.7)36 (41.4)38 (46.3)
 Due to AEs4 (4.8)6 (6.9)4 (4.9)
Diarrhea, any grade64 (76.2)39 (44.8)21 (25.6)
 Grade 310 (11.9)2 (2.3)1 (1.2)
 Grade 4000
 SAE2 (2.4)1 (1.1)0
Asthenia, any grade23 (27.4)17 (19.5)13 (15.9)
 Grade 35 (6.0)1 (1.1)1 (1.2)
 Grade 4000
 SAE1 (1.2)00
Fatigue, any grade21 (25.0)22 (25.3)24 (29.3)
 Grade 33 (3.6)3 (3.4)2 (2.4)
 Grade 4000
 SAE001 (1.2)
Decreased appetite, any grade21 (25.0)19 (21.8)12 (14.6)
 Grade 31 (1.2)00
 Grade 4000
 SAE000
Back pain, any grade15 (17.9)18 (20.7)21 (25.6)
 Grade 31 (1.2)3 (3.4)1 (1.2)
 Grade 4000
 SAE1 (1.2)1 (1.1)1 (1.2)
Nausea, any grade44 (52.4)30 (34.5)20 (24.4)
 Grade 32 (2.4)00
 Grade 4000
 SAE001 (1.2)
Vomiting, any grade26 (31.0)24 (27.6)12 (14.6)
 Grade 301 (1.1)0
 Grade 4000
 SAE001 (1.2)

Abbreviation: SAE, serious AE.