Table 4.
Selected toxicities (Common Terminology Criteria for Adverse Events v. 4), fractures, osteonecrosis, and treatment discontinuation by treatment arm*
| Adverse event | ZA (n = 2124) |
CLOD (n = 2185) |
IBAN (n = 1527) |
|||
|---|---|---|---|---|---|---|
| Grade |
Grade |
Grade |
||||
| 3 | 4 | 3 | 4 | 3 | 4 | |
| All grade 3, 4 adverse events (%) | 178 (8.4) | 9 (0.4) | 171 (7.8) | 10 (0.5) | 154 (10.1) | 6 (0.4) |
| Constitutional symptoms, No. | 13 | 1 | 17 | 0 | 8 | 0 |
| Gastrointestinal, No. | 10 | 0 | 51 | 0 | 34 | 0 |
| Metabolic/Laboratory, No. | 27 | 2 | 18 | 4 | 18 | 1 |
| Creatinine | 2 | 0 | 1 | 0 | 3 | 1 |
| Hypocalcemia | 1 | 2 | 1 | 1 | 1 | 0 |
| Musculoskeletal/Soft tissue, No. | 11 | 0 | 8 | 0 | 8 | 1 |
| Pain, No. | 90 | 3 | 60 | 0 | 70 | 3 |
| Renal/Genitourinary, No. | 3 | 0 | 2 | 0 | 7 | 0 |
| No. of patients with fractures (% of all patients) | 159 (7.1) | 207 (9.3) | 115 (7.4) | |||
| No. of patients with traumatic fractures (% of all patients) | 42 (1.9) | 45 (2.0) | 27 (1.7) | |||
| No. of patients with osteonecrosis (% of all patients) | 28 (1.26) | 8 (0.36) | 12 (0.77) | |||
| Off treatment because of AEs/side effects (%) | 224/2231 (10.0) | 381/2235 (17.0) | 267/1552 (17.2) | |||
| Completed all therapy (%) | 1410/2231 (63.2) | 1276/2235 (57.1) | 943/1552 (60.8) | |||
*AEs = adverse events;: CLOD = clodronate; DFS = disease-free survival; IBAN = ibandronate; ZA = zoledronic acid.