Table 2 Adverse events (all grades [≥10%] and grades 3/4, regardless of causality) by treatment group
Preferred term, n (%) | 3 mg/kg QW n = 1 | 10 mg/kg QW n = 5 | 20 mg/kg QW n = 6 | 40 mg/kg QW RDE, n = 36 | 20 mg/kg Q2W n = 6 | All patients N = 54 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Â | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 |
Diarrhea | 0 | 0 | 2 (40) | 0 | 5 (83) | 1 (17) | 18 (50) | 1 (3) | 3 (50) | 1 (17) | 28 (52) | 3 (6) |
Decreased appetite | 0 | 0 | 3 (60) | 0 | 4 (67) | 0 | 16 (44) | 0 | 1 (17) | 0 | 24 (44) | 0 |
Pyrexia | 0 | 0 | 2 (40) | 0 | 2 (33) | 0 | 18 (50) | 1 (3) | 0 | 0 | 22 (41) | 1 (2) |
Fatigue | 0 | 0 | 2 (40) | 0 | 2 (33) | 1 (17) | 14 (39) | 0 | 1 (17) | 0 | 19 (35) | 1 (2) |
Nausea | 1 (100) | 0 | 3 (60) | 0 | 3 (50) | 1 (17) | 12 (33) | 1 (3) | 0 | 0 | 19 (35) | 2 (4) |
Infusion-related reaction | 0 | 0 | 0 | 0 | 3 (50) | 0 | 13 (36) | 0 | 1 (17) | 0 | 17 (31) | 0 |
Vomiting | 1 (100) | 0 | 1 (20) | 0 | 2 (33) | 1 (17) | 10 (28) | 2 (6) | 2 (33) | 0 | 16 (30) | 3 (6) |
Constipation | 1 (100) | 0 | 0 | 0 | 3 (50) | 0 | 10 (28) | 0 | 1 (17) | 0 | 15 (28) | 0 |
Dyspnea | 0 | 0 | 1 (20) | 0 | 1 (17) | 1 (17) | 10 (28) | 2 (6) | 3 (50) | 1 (17) | 15 (28) | 4 (7) |
Anemia | 0 | 0 | 1 (20) | 0 | 3 (50) | 1 (17) | 10 (28) | 6 (17) | 0 | 0 | 14 (26) | 7 (13) |
Hypomagnesemia | 0 | 0 | 3 (60) | 0 | 5 (50) | 0 | 7 (19) | 0 | 1 (17) | 0 | 14 (26) | 0 |
Hypokalemia | 1 (100) | 0 | 2 (40) | 0 | 0 | 0 | 9 (25) | 4 (11) | 1 (17) | 0 | 13 (24) | 4 (7) |
Chills | 0 | 0 | 0 | 0 | 2 (33) | 0 | 11 (31) | 0 | 0 | 0 | 13 (24) | 0 |
Cough | 0 | 0 | 1 (20) | 0 | 1 (17) | 0 | 8 (22) | 0 | 1 (17) | 0 | 11 (20) | 0 |
Headache | 0 | 0 | 2 (40) | 0 | 1 (17) | 0 | 7 (19) | 0 | 0 | 0 | 10 (19) | 0 |
Stomatitis | 0 | 0 | 0 | 0 | 2 (33) | 0 | 7 (19) | 0 | 1 (17) | 0 | 10 (19) | 0 |
AST increased | 0 | 0 | 2 (40) | 0 | 1 (17) | 0 | 6 (17) | 0 | 0 | 0 | 9 (17) | 0 |
Asthenia | 0 | 0 | 0 | 0 | 2 (33) | 1 (17) | 5 (14) | 1 (3) | 2 (33) | 1 (17) | 9 (17) | 3 (6) |
Myalgia | 0 | 0 | 0 | 0 | 1 (17) | 0 | 7 (19) | 0 | 1 (17) | 0 | 9 (17) | 0 |
Blood ALP increased | 1 (100) | 0 | 1 (20) | 0 | 2 (33) | 0 | 4 (11) | 2 (6) | 0 | 0 | 8 (15) | 2 (4) |
Hypophosphatemia | 0 | 0 | 0 | 0 | 0 | 0 | 8 (22) | 5 (14) | 0 | 0 | 8 (15) | 5 (9) |
Pruritus | 0 | 0 | 1 (20) | 0 | 1 (17) | 0 | 5 (14) | 0 | 1 (17) | 0 | 8 (15) | 0 |
Pneumonia | 0 | 0 | 0 | 0 | 0 | 0 | 8 (22) | 6 (17) | 0 | 0 | 8 (15) | 6 (11) |
Rash | 0 | 0 | 0 | 0 | 1 (17) | 0 | 6 (17) | 0 | 1 (17) | 0 | 8 (15) | 0 |
Abdominal pain | 0 | 0 | 0 | 0 | 0 | 0 | 6 (17) | 1 (3) | 1 (17) | 0 | 7 (13) | 1 (2) |
Dehydration | 0 | 0 | 1 (20) | 0 | 2 (33) | 1 (17) | 4 (11) | 2 (6) | 0 | 0 | 7 (13) | 3 (6) |
Dry skin | 0 | 0 | 1 (20) | 0 | 2 (33) | 0 | 4 (11) | 0 | 0 | 0 | 7 (13) | 0 |
Hypoalbuminemia | 0 | 0 | 0 | 0 | 3 (50) | 0 | 4 (11) | 0 | 0 | 0 | 7 (13) | 0 |
Peripheral edema | 0 | 0 | 1 (20) | 0 | 1 (17) | 0 | 4 (11) | 0 | 1 (17) | 0 | 7 (13) | 0 |
Weight decreased | 0 | 0 | 1 (20) | 0 | 2 (33) | 0 | 4 (11) | 0 | 0 | 0 | 7 (13) | 0 |
Pleural effusion | 0 | 0 | 1 (20) | 1 (20) | 0 | 0 | 4 (11) | 1 (3) | 1 (17) | 1 (17) | 6 (11) | 3 (6) |
Muscular weakness | 0 | 0 | 1 (20) | 0 | 1 (17) | 0 | 2 (6) | 0 | 2 (33) | 0 | 6 (11) | 0 |