Table 2

Adverse events

SummaryZoledronate
(n=50)
Placebo
(n=50)
Serious adverse events48 events in 19 pts35 events in 18 pts
Adverse events94 events in 38 pts82 events in 38 pts
Number of serious adverse events reported/number of patients reporting at least one serious adverse event
 Deaths2 pts0 pts
 Acute-phase reaction1 event in 1 pt0 events in 0 pts
 Cardiovascular14 events in 9 pts14 events in 9 pts
 Gastrointestinal4 events in 3 pts3 events in 3 pts
 Infectious disease8 events in 7 pts11 events in 9 pts
 Musculoskeletal10 events in 5 pts4 events in 3 pts
 Haematological1 event in 1 pt0 events in 0 pts
 Neurological2 events in 2 pts0 events in 0 pts
 Renal1 event in 1 pt0 events in 0 pts
 Respiratory6 events in 5 pts3 events in 2 pts
 Skin1 event in 1 pt0 events in 0 pts
Number of gout-related adverse events reported/number of patients reporting at least one adverse event
 Gout-related serious adverse event7 events in 4 pts0 events in 0 pts*
 Gout-related adverse event21 events in 11 pts16 events in 11 pts†
Acute phase response following infusion
 Acute phase response following baseline visit‡25/50 (50%)18/50 (36%)
 Acute phase response following Year 1 visit‡12/46 (26%)13/45 (29%)
  • *Fisher's exact test p=0.12, comparing patients (pts) with at least one flare.

  • †p=0.99.

  • ‡According to postinfusion questionnaire. One participant in the placebo group did not complete the postinfusion questionnaire after the Year 1 infusion.