Table 4.

Percentage of visits at which subjects reported side effects [n (%)]

Side effect	ZOL group (n = 155)	Placebo group (n = 95)	P‐value
Headache (influenza‐like illness)	21 (13.5)	2 (2.1)	0.003
Pyrexia	43 (27.7)	3 (3.2)	<0.001
Myalgia	34 (21.9)	4 (4.2)	<0.001
Arthralgia	29 (18.7)	11 (11.6)	0.157
Back pain	24 (15.4)	14 (14.7)	1

Adverse events (AE) that occurred in >5.0% of patients within 3 days of initial dosing.

Five most common adverse events in zoledronic acid group.

P‐values were calculated with the use of Fisher's exact test. The output data of 2‐Tail P‐values were collected as the last P‐values. The two‐tail P‐value is calculated.

Patients with more than one AE may appear in both occurrence categories. A participant with multiple occurrences of an adverse event within a preferred term (according to codes used in the Medical Dictionary for Regulatory Activities) was counted only once.