Safety
swelling, infections, allergic reactions
ADVERSE EVENTS, INFECTIONS, ALLERGIC REACTION
There were no procedure-related serious adverse events (AEs) reported, which includes any allergic reactions or symptomatic infections seen in any treated patient. However, there were multiple related AEs reported that have been subdivided. The following related AEs demonstrated significance between cohorts: joint swelling (CSI 7.4% versus UCT 24.1%, Summary of AEs by treatment group according to MedDRA systemThe safety population is defined as the 440 subjects who received study treatment. The AEs are those with an incidence of at least 5%. MedDRA denotes Medical Dictionary for Regulatory Activities, version 21.1.95% CIs that do not overlap are statistically significant.Summary of procedure related AEs by study armThe safety population is defined as the 440 subjects who received study treatment. The AEs are those with an incidence of at least 5%. MedDRA denotes Medical Dictionary for Regulatory Activities, version 21.1.95% CIs that do not overlap are statistically significant.