Table 4.
AEs occurring in ≥20% of all patients.
| COMBO5 (n = 10) |
COMBO7.5 (n = 6) |
COMBO10 (n = 4) |
All patients (N = 20) |
|||||
|---|---|---|---|---|---|---|---|---|
| All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | |
| Any AE | 10 (100.0) | 7 (70.0) | 6 (100.0) | 5 (83.3) | 4 (100.0) | 4 (100.0) | 20 (100.0) | 16 (80.0) |
| Any SAE | 8 (80.0) | 6 (60.0) | 4 (66.7) | 3 (50.0) | 3 (75.0) | 3 (75.0) | 15 (75.0) | 12 (60.0) |
| Hypercalcemia | 5 (50.0) | 1 (10.0) | 5 (83.3) | 2 (33.3) | 4 (100.0) | 4 (100.0) | 14 (70.0) | 7 (35.0) |
| Arthralgia | 5 (50.0) | 0 | 4 (66.7) | 0 | 4 (100.0) | 0 | 13 (65.0) | 0 |
| Fatigue | 6 (60.0) | 0 | 2 (33.3) | 0 | 3 (75.0) | 0 | 11 (55.0) | 0 |
| Anemia | 5 (50.0) | 1 (10.0) | 2 (33.3) | 0 | 3 (75.0) | 2 (50.0) | 10 (50.0) | 3 (15.0) |
| Bone fracture | 4 (40.0) | 1 (10.0) | 4 (66.7) | 3 (50.0) | 1 (25.0) | 1 (25.0) | 9 (45.0) | 5 (25.0) |
| Constipation | 5 (50.0) | 0 | 2 (33.3) | 0 | 2 (50.0) | 0 | 9 (45.0) | 0 |
| Nausea | 4 (40.0) | 0 | 4 (66.7) | 0 | 1 (25.0) | 0 | 9 (45.0) | 0 |
| Back pain | 3 (30.0) | 1 (10.0) | 3 (50.0) | 1 (16.7) | 2 (50.0) | 0 | 8 (40.0) | 2 (10.0) |
| Hypophosphatemia | 4 (40.0) | 3 (30.0) | 2 (33.3) | 1 (16.7) | 2 (50.0) | 1 (25.0) | 8 (40.0) | 5 (25.0) |
| Pyrexia | 5 (50.0) | 0 | 2 (33.3) | 0 | 1 (25.0) | 0 | 8 (40.0) | 0 |
| Vomiting | 4 (40.0) | 0 | 2 (33.3) | 0 | 2 (50.0) | 0 | 8 (40.0) | 0 |
| Decreased appetite | 3 (30.0) | 0 | 2 (33.3) | 1 (16.7) | 2 (50.0) | 0 | 7 (35.0) | 1 (5.0) |
| Dysgeusia | 2 (20.0) | 0 | 2 (33.3) | 0 | 3 (75.0) | 0 | 7 (35.0) | 0 |
| Hypokalemia | 3 (30.0) | 0 | 2 (33.3) | 0 | 2 (50.0) | 1 (25.0) | 7 (35.0) | 1 (5.0) |
| Hypomagnesemia | 3 (30.0) | 0 | 1 (16.7) | 0 | 3 (75.0) | 1 (25.0) | 7 (35.0) | 1 (5.0) |
| Myalgia | 3 (30.0) | 0 | 2 (33.3) | 0 | 2 (50.0) | 0 | 7 (35.0) | 0 |
| Peripheral edema | 3 (30.0) | 0 | 0 | 0 | 4 (100.0) | 0 | 7 (35.0) | 0 |
| Abdominal pain | 2 (20.0) | 0 | 2 (33.3) | 0 | 2 (50.0) | 0 | 6 (30.0) | 0 |
| Diarrhea | 3 (30.0) | 0 | 1 (16.7) | 0 | 1 (25.0) | 0 | 5 (25.0) | 0 |
| Hypocalcemia | 1 (10.0) | 0 | 1 (16.7) | 0 | 3 (75.0) | 1 (25.0) | 5 (25.0) | 1 (5.0) |
| Osteoporosis | 2 (20.0) | 0 | 2 (33.3) | 0 | 1 (25.0) | 0 | 5 (25.0) | 0 |
| Pain in extremity | 2 (20.0) | 0 | 1 (16.7) | 0 | 2 (50.0) | 1 (25.0) | 5 (25.0) | 1 (5.0) |
| Weight decreased | 1 (10.0) | 0 | 2 (33.3) | 0 | 2 (50.0) | 0 | 5 (25.0) | 0 |
| Increased aspartate aminotransferase | 2 (20.0) | 2 (20.0) | 1 (16.7) | 1 (16.7) | 1 (25.0) | 1 (25.0) | 4 (20.0) | 4 (20.0) |
| Increased blood bilirubin | 1 (10.0) | 0 | 2 (33.3) | 1 (16.7) | 1 (25.0) | 1 (25.0) | 4 (20.0) | 2 (10.0) |
| Increased blood creatinine | 0 | 0 | 1 (16.7) | 0 | 3 (75.0) | 1 (25.0) | 4 (20.0) | 1 (5.0) |
| Chills | 2 (20.0) | 0 | 1 (16.7) | 0 | 1 (25.0) | 0 | 4 (20.0) | 0 |
| Dyspnea | 2 (20.0) | 0 | 2 (33.3) | 1 (16.7) | 0 | 0 | 4 (20.0) | 1 (5.0) |
| Headache | 2 (20.0) | 1 (10.0) | 2 (33.3) | 0 | 0 | 0 | 4 (20.0) | 1 (5.0) |
| Infusion-related reaction | 1 (10.0) | 0 | 2 (33.3) | 1 (16.7) | 1 (25.0) | 0 | 4 (20.0) | 1 (5.0) |
| Musculoskeletal pain | 4 (40.0) | 0 | 0 | 0 | 0 | 0 | 4 (20.0) | 0 |
| Peripheral sensory neuropathy | 1 (10.0) | 0 | 2 (33.3) | 0 | 1 (25.0) | 0 | 4 (20.0) | 0 |
Data are n (%).
Abbreviations: AE, adverse event; SAE, serious adverse event.