F2 and digestive system disorder: The most common treatment-related events by System Organ Class were gastrointestinal disorders (n = 4 [10.8%]), skin and subcutaneous tissue disorders (n = 3 [8.1%]), and investigations (n = 3 [8.1%]; includes 2 cases of QT prolongation [both in 3- to 5-year-old group] and 1 case each of PR prolongation [3- to 5-year-old], U wave present [3- to 5-year-old], and prothrombin time prolonged [0- to 2-year-old]).