EVENT RZLT-ERSODETUG-2026
SCORED SET evaluable
FLOOR floor_primary_gir_reduction_definition primary_gir_reduction_percent >= 50 | A primary responder must meet the stated reduction-from-baseline threshold in IV GIR.
BAR bar_primary_responder_count primary_gir_responder_count >= 9 | At least the company-stated open-label responder count meets the primary GIR threshold.
DIFF diff_complete_iv_dextrose_tpn_discontinuation complete_iv_dextrose_tpn_discontinuation_percent >= 75 | At least the prior EAP percentage achieves complete discontinuation of IV dextrose/TPN; this is supportive, not the registered primary endpoint.