Table 1.

Summary of emergent adverse events by relationship, intensity and system organ class

Relationship	Intensity	System organ class (number)
Probably	Mild	Paresthesia (7)
Possibly	Mild	Pruritus/rash (2); salivary hypersecretion (1)
Unlikely	Mild	nausea (1)
Unrelated	Moderate	Urinary tract infection (1); facial bone fracture (1)
	Mild	Infections (16); headache/paresthesia (10); gastrointestinal disorders (6); general disorders (5); epistaxis (2); injury (1); musculoskeletal chest pain (1); pregnancy (1)