Table 2.

Treatment-emergent AEs

All rilotumumab + MP (n = 89)Placebo + MP (n = 49)
Any gradeGrade ≥ 3Any gradeGrade ≥ 3
Patients reporting ≥1 AE, n (%)88 (99)56 (63)49 (100)23 (47)
Nausea39 (44)2 (2)17 (35)0 (0)
Fatigue37 (42)6 (7)22 (45)5 (10)
Vomiting22 (25)0 (0)12 (24)1 (2)
Peripheral edema21 (24)1 (1)4 (8)0 (0)
Constipation18 (20)0 (0)17 (35)1 (2)
Back pain17 (19)1 (1)10 (20)1 (2)
Decreased appetite16 (18)1 (1)10 (20)0 (0)
Diarrhea16 (18)0 (0)6 (12)0 (0)
Anemia14 (16)4 (4)8 (16)2 (4)
Dyspnea14 (16)0 (0)7 (14)1 (2)
Neutropenia14 (16)8 (9)4 (8)3 (6)
Arthralgia14 (16)1 (1)4 (8)0 (0)
Bone pain11 (12)3 (3)8 (16)5 (10)
Pulmonary embolism10 (11)10 (11)4 (8)4 (8)
Pyrexia10 (11)1 (1)4 (8)0 (0)
Asthenia10 (11)2 (2)3 (6)1 (2)
Dizziness9 (10)1 (1)6 (12)0 (0)
Pain in extremity8 (9)0 (0)7 (14)0 (0)
Decreased weight6 (7)0 (0)7 (14)0 (0)

NOTE: Includes all patients who received ≥1 dose of study drug. Any grade AE occurring in more than 10% of patients in either the combined rilotumumab or control arms are reported.