Serious adverse events
thoracic and mediastinal disorders
CARDIAC DISORDERS
These occurred in 15 (27%) patients in the intervention arm and 4 (15%) in the control arm. The most common system organ classes of the SAEs were “respiratory, thoracic and mediastinal disorders” [10 (17.9%) and 2 (7.4%)], “infections and infestations” [6 (10.7%) and 1 (3.7%)], and “cardiac disorders” [3 (5.4%) and 0]. Details are listed in None of the AEs or SAEs were judged as being related to the study drug by the investigators.