Table 5

Adverse events by category and group.

NSM (n=46)SI Joint Fusion (n=102)
Body systemN (%)N (%)P-value
Arm/hand2 (4.3%)9 (8.8%)0.5035
Back4 (8.7%)16 (15.7)0.3070
Cardiovascular1 (2.2%)6 (5.9%)0.4360
Endocrine1 (2.2%)1 (1.0%)0.5265
Gastroenterologic4 (8.7%)11 (10.8%)0.7779
Genitourinary0 (0%)5 (4.9%)0.3248
Infection3 (6.5%)3 (2.9%)0.3752
Leg8 (17.4%)21 (20.6%)0.8234
Miscellaneous4 (8.7%)3 (2.9%)0.2042
Neck0 (0.0%)2 (2.0%)1.0000
Pelvis10 (21.7%)34 (33.3%)0.1773
Psychiatric0 (0.0%)1 (1.0%)1.0000
Pulmonary4 (8.7%)1 (1.0%)0.0326
Surgical wound0 (0.0%)6 (5.9%)0.1774
Trauma7 (15.2%)14 (13.7%)0.8033
  • * Number of events and rate (events divided by total number of trial subjects)