Adverse events
swelling, erythema, pain, infusion-site, tenderness/pain
ADVERSE EVENTS, ERYTHEMA, HYPERPIGMENTATION
There were 101 adverse events reported during the study with no serious adverse events (Table S5). All participants experienced some infusion-site reaction including erythema, swelling, tenderness/pain, and pigmentation ranging in duration from less than 1 day (pain) to 217 days (hyperpigmentation). There were two off-study referrals for post-infusion hyperpigmentation, but no treatment was required, as they resolved spontaneously. Ultrasound changes were recorded in all participants post-infusion and were detectable between 4 and 9 months. Non-specific hyperechoic changes were noted in most participants, but two participants developed a loculated collection that resolved by 6.5 and 8.3 months.