Table 1.

Clinically significant increase in oral body temperature, rescue medication use, worsening symptoms, and severe symptoms during the 3-day period following IV zoledronic acid infusion

Variables	PLAC (N = 267)		ACET (N = 264)		FLUV (N = 262)
	Number	Percentage (%)	Number	Percentage (%)	Number	Percentage (%)
Clinically significant increase in temperaturea	28	10.5	13	4.9b	30	11.5
Use of rescue medication	153	57.3	102	38.6c	156	59.5
Major increase in severity of symptoms
Feeling feverish	105	39.3	62	23.5c	104	39.7
Headache	104	39.0	67	25.4c	115	43.9
Aches and pains	127	47.6	89	33.7c	121	46.2
Severe symptoms (reported at least once)
Feeling feverish	36	13.5	20	7.6b	38	14.5
Headache	42	15.7	18	6.8c	42	16.0
Aches and pains	81	30.3	56	21.2b	79	30.2

ACET acetaminophen, FLUV fluvastatin, PLAC placebo

^a1°C or more from baseline and 38.5°C or more overall

^b p < 0.05 vs. placebo

^c p ≤ 0.001 vs. placebo