TABLE III.

Adverse Events by Relationship to Study Device, Severity, Treatment, and Timing

		Conservative Management Event Severity†			Sacroiliac Joint Arthrodesis Event Severity†
Probably or Definitely Related to Study Device or Procedure	Event Timing*	Mild	Moderate	Severe	Mild	Moderate	Severe
No	≤6 months	3	3	11	2	2	12
	>6 months	2	10	15	4	7	23
Yes	≤6 months	0	0	0	0	0	4
	>6 months	1	1	1	0	0	0
All events	All	6	14	27	6	9	39

^*The time of 6 months corresponds to 200 days after assignment either to conservative management or sacroiliac joint arthrodesis.

^†The values are given as the number of adverse events.