Table 2.
Placebo (n=1623) | Clodronate (n=1612) | |||||
---|---|---|---|---|---|---|
Toxicity | Grade 3 n (%) |
Grade 4 n (%) |
Grade 5 n (%) |
Grade 3 n (%) |
Grade 4 n (%) |
Grade 5 n (%) |
Overall | 223 (14) | 110 (7) | 12 (1) | 247 (15) | 85 (5) | 5 (<1) |
Diarrhea | 10 (<1) | 0 | 0 | 27 (2) | 1 (<1) | 0 |
ALT/AST | 10 (<1) | 2 (<1) | 0 | 21 (1) | 2 (<1) | 0 |
Hypocalcemia | 2 (<1) | 0 | 0 | 1 (<1) | 0 | 0 |
Creatinine | 0 | 0 | 0 | 3 (<1) | 1 (<1) | 0 |
Thrombosis or embolism | 17 (1) | 13 (<1) | 0 | 13 (1) | 4 (<1) | 0 |
Pancreatitis | 1 (<1) | 0 | 0 | 5 (<1) | 0 | 0 |
Based on the National Cancer Institute’s common toxicity criteria, version 4.0. ALT=alanine aminotransferase. AST=aspartate aminotransferase.
Information on toxic effects was available for 97% (3235/3323) of patients enrolled in the study.