Table 1.

Demographics and baseline characteristics

Rilotumumab 15 mg/kg + MP (n = 45)Rilotumumab 7.5 mg/kg + MP (n = 48)Placebo + MP (n = 49)
Age, y
 Median676769
 Range48–8754–8749–84
Age group at randomization, n (%)
 <65 y16 (36)15 (31)13 (27)
 ≥65–<75 y25 (56)24 (50)24 (49)
 ≥75 y4 (9)9 (19)12 (24)
Race, n (%)
 White/Caucasian42 (93)43 (90)44 (90)
 Black/African American2 (4)1 (2)3 (6)
 Hispanic/Latino0 (0)0 (0)2 (4)
 Asian1 (2)3 (6)0 (0)
 Native Hawaiian/other Pacific Islander0 (0)1 (2)0 (0)
ECOG performance status, n (%)
 014 (31)11 (23)19 (39)
 131 (69)34 (71)30 (61)
 20 (0)1 (2)0 (0)
 30 (0)1 (2)0 (0)
 Missing0 (0)1 (2)0 (0)
Measurable disease at baseline, n (%)25 (56)27 (56)28 (57)
Visceral metastatic disease, n (%)10 (22)13 (27)9 (18)
Gleason score at diagnosis, n (%)
 2–66 (13)7 (15)10 (20)
 713 (29)17 (35)15 (31)
 8–1022 (49)21 (44)22 (45)
 Missing4 (9)3 (6)2 (4)
PSA levels at baseline, ng/mL
 Median99171142
 Range4–2,1483–4,0739–3,853
PSA doubling time, n (%)
 <55 d14 (31)17 (35)22 (45)
 ≥55 d26 (58)29 (60)26 (53)
 Missing5 (11)2 (4)1 (2)
Bone pain at baseline, n (%)27 (60)28 (58)28 (57)
Response to prior taxane-based chemotherapy, n (%)32 (71)34 (71)36 (73)
Disease progression during prior taxane-based chemotherapy, n (%)23 (51)26 (54)23 (47)
Disease progression >3 mo since prior taxane-based chemotherapy, n (%)10 (22)8 (17)18 (37)

NOTE: Full analysis set.