Safety
congenital anomaly, treatment-emergent adverse, chest pain, diabetes mellitus, DKA, Hearing impairments, pressure-like, nonradiating
CONDUCTIVE DEAFNESS, ADVERSE EVENT, EVENT, DIABETES MELLITUS, CONDUCTIVE HEARING LOSS, ADVERSE EVENT, HEARING IMPAIRMENT, INFUSION REACTION, EVENTS
Adverse events (AEs) were reported in similar proportions of patients in the teprotumumab (33 of 41, 80.5%) and placebo (16 of 20, 80%) groups. The AEs described in previous teprotumumab studies and as included in the prescribed label for teprotumumab are presented in Patients with treatment-emergent adverse events during the double-masked treatment periodThe safety analysis set included patients who had received at least one dose of drug. Within each AESI (adverse event of special interest) category, patients are counted once for each system organ class and once for each preferred term.


In most patients (97.6% for the teprotumumab, and 95% for the placebo group) AEs were Grade 1 or 2. Two AEs led to discontinuation: one placebo patient (infusion-related) and one teprotumumab patient with left ear conductive hearing loss (patient had a congenital anomaly); the event occurred in the masked period, the patient completed the masked period and discontinued in the open-label period).AEs of special interest (AESI) were reported in 15 (36.6%) patients in the teprotumumab and 7 (35%) in the placebo group. Hearing impairments were reported in 9 (22%) patients treated with teprotumumab and 2 (10%) who received placebo (Supplementary Table S5 (Hyperglycemic events were reported in 6 (14.6%) patients in the teprotumumab and 2 (10%) in the placebo group (Supplementary Table S6 (Infusion-related reactions were reported in 2 (4.9%) teprotumumab and 3 (15%) placebo patients and were mostly managed with medication; 1 patient in the placebo group (5%) discontinued due to an infusion reaction (dull cardiac-related chest pain, pressure-like, nonradiating, slight difficulty breathing).Serious AEs were reported in 1 (2.4%) teprotumumab (conductive deafness in patient with congenital anomaly) and 1 (5%) placebo-assigned patient (DKA in patient with undiagnosed diabetes mellitus who received teprotumumab infusion in error, described above).