Safety
metabolic and nutritional diseases
SKIN REDNESS, ADVERSE REACTIONS, MEDIASTINAL DISEASE, INFUSION REACTION
All 88 subjects in this trial entered the Safety Analysis Set (SS) and completed the administration as per the protocol. A total of 81 subjects experienced 306 AEs, with one subject experiencing “skin redness” prior to receiving the test drug; the remaining 81 subjects (305 cases) were treatment-emergent AEs (TEAEs), with an incidence rate of 92.05%; 40 subjects (152 cases) in the test group had AEs, with an incidence rate of 90.91%; and 41 subjects (153 cases) in the reference group had AEs, with an incidence rate of 93.18%. Adverse reactions (ARs) occurred in 80 subjects (253 cases), with an incidence rate of 90.91%; 40 cases (124 subjects) in the test group had ARs, with an incidence rate of 90.91%; and 40 subjects (129 cases) in the reference group had ARs, with an incidence rate of 90.91%; and one case (1.14%) had an infusion reaction. The two groups had similar rates of AEs and ARs. No SAE, suspected unexpected serious ARs, AEs of particular concern, or AEs that resulted in the study’s termination were noted.AEs that occurred during the trial were summarized using system organ classification and preferred term: at least one AE occurred in 40 subjects in the test group, with an incidence rate of 90.91%; 41 subjects in the reference group experienced at least one AE, with an incidence rate of 93.18%. The AEs that occurred in the two groups were “various examinations” (the incidence of AEs in the test group and the reference group was 84.09% and 75.00%, respectively), “metabolic and nutritional diseases” (the incidence of AEs in the two groups was 45.45% and 61.36%, respectively), and “respiratory system, thoracic, and mediastinal diseases” (the incidence of AEs in the two groups was 4.55% and 18.18%, respectively) (Table Summary of adverse eventsThe vital signs of all subjects were primarily stable throughout the trial; 8 had clinically significant physical examination abnormalities, 77 had clinically significant laboratory abnormalities, and 4 had clinically significant abnormal 12-lead ECG. These abnormalities were mild, and returned to normal without intervention. The chest X-ray, abdominal ultrasonography, and urinary system ultrasonography were normal or abnormal with no clinical implications.