Safety Evaluation
pyrexia, deaths, erythema, diarrhea
VIRAL RESPIRATORY TRACT INFECTION, ADVERSE EVENT, SUDDEN CARDIAC DEATH, CORONAVIRUS INFECTION, ERYTHEMA, VIRAL PNEUMONIA, MULTIPLE ORGAN DYSFUNCTION SYNDROME, EVENTS
A summary of the treatment-emergent AEs and the treatment-emergent serious AEs in part 1 and in part 2 is shown in Table Treatment-Emergent Adverse Events (Safety Population)The most commonly reported treatment-emergent AEs did not differ between treatment groups in either part of the study. In part 1, the most common treatment-emergent AEs were viral respiratory tract infection (n=2 [5.4%] inclisiran; n=2 [10.5%] placebo), diarrhea, and pyrexia (n=2 [5.4% inclisiran]; 0 placebo); in part 2, they were coronavirus infection (n=3 [8.8%] inclisiran–inclisiran; n=1 [5.3%] placebo–inclisiran) and an increased international normalized ratio (n=2 [5.9%] inclisiran–inclisiran; n=1 [5.3%] placebo–inclisiran). During the entire study, only one patient (2.9%) had an AE at the injection site (erythema); this was in the inclisiran–inclisiran group during part 2, and the AE was mild in severity, not persistent, and resolved rapidly.Although the AEs and serious AEs were based on a small number of events reported in a small data pool, the incidences of these did not differ between the inclisiran and placebo groups throughout the entire study or between the parts of the study. Three deaths were reported during the study, all during part 2. None of these deaths were related to inclisiran treatment, and all were attributed by the investigator to other factors (multiple organ dysfunction syndrome, sudden cardiac death, and viral pneumonia). No anti-inclisiran antibodies were detected in any of the samples during the study.