De Bono J et al. J Clin Oncol 2016;34(suppl):abstract 5008 - ClinicalTrials.gov NCT01308580
PROSELICA – Most frequent grade ≥3 TEAEs
CABA 20 + P
N=580
CABA 25 + P
N=595
Grade 3-4
Grade 3-4
Febrile neutropenia
12 (2.1)
55 (9.2)
Hematuria
11 (1.9)
25 (4.2)
Diarrhea
8 (1.4)
24 (4.0)
Fatigue
15 (2.6)
22 (3.7)
Urinary tract infection
10 (1.7)
13 (2.2)
Bone pain
10 (1.7)
13 (2.2)
Asthenia
11 (1.9)
12 (2.0)
Vomiting
7 (1.2)
8 (1.3)
Nausea
4 (0.7)
7 (1.2)
Prophylactic (G-CSF) not allowed at cycle 1
TEAE ≥ 5%
G-CSF: granulocyte-colony stimulating factor
SAEU.CAB.16.07.0040j
