Table 2.

Side-effects and toxic effects^*

	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.