Table 3.

Adverse events through Week 52 (n = 5).

Event term	CTCAE grade	Seriousness (ICH E2A)	Relatedness	Onset date	Resolution date	Action taken
None observed	None observed	None observed	None observed	None observed	None observed	None observed

Events are coded and graded according to CTCAE v5.0; seriousness is defined per ICH E2A. Relationship to study treatment was assessed by the investigator. No treatment-related AEs or SAEs were observed, and no immediate intra-articular flares (swelling/pain), infections, hemarthrosis, or hospitalizations occurred. Counts reflect observed cases only (no imputation). AE, adverse event; SAE, serious adverse event; CTCAE, Common Terminology Criteria for Adverse Events; ICH, International Council for Harmonisation.