Efficacy and safety assessment
GERD, death, TEAEs, disability
ADVERSE EVENTS, ADVERSE EVENT, GERD, REMISSION, ADVERSE EVENT
The primary endpoint of the study was the complete healing rate of EE confirmed endoscopically up to week 8 in the per-protocol set (PPS) population. The complete healing of EE was defined as the LA Classification criterion “Not Present” in endoscopy after administration of the clinical trial drug [Patients were instructed to rate the severity of their worst GERD symptom episodes experienced in the previous 24 h. This information was recorded in a diary every morning using a 4-point scale: 0 (no symptoms), 1 (symptoms with spontaneous remission, not significantly affecting normal activities or sleep), 2 (symptoms with spontaneous but slow remission, somewhat impeding normal activities or sleep), and 3 (symptoms with no spontaneous remission, remarkably impeding normal activities or sleep). Complete resolution of symptoms was defined as patients reporting no symptoms (score 0) during the 7 days before the follow-up visit. Sustained resolution was defined as 7 consecutive days of GERD symptoms recorded as a score of 0 (no symptoms), and the time to sustained resolution of symptoms was determined as the first day of the symptom-free period. To assess the proportion of symptom-free days and nights, the percentage of days without daytime or night-time symptoms during treatment was calculated. Similarly, the percentage of nights without night-time symptoms was assessed using a daily diary.All safety assessments, including frequency and severity of adverse events, clinical laboratory evaluations, 12-lead electrocardiogram results, vital sign measurements, and physical examination findings, were monitored throughout the study. A TEAE was defined as an adverse event that occurred during treatment and represented a change from baseline. All TEAEs were graded by the investigator as mild, moderate, or severe. Adverse events were considered drug related if they were deemed by the investigator to be possibly related to or related to the study drug. Serious TEAEs were defined as adverse events that could potentially cause death, hospitalization, disability, or life-threatening adverse events.