“…Studies evaluating alteplase [12, 14, 15, 20-22, 24, 26, 28, 32], urokinase [4,6,9,10,15,23,25,27,[29][30][31], and reteplase [8,11,16,18,19] did not report AEs attributed to the drugs studied, but generally provided insufficient safety data to adequately detect infrequent yet potentially important AEs. In contrast, as the first phase III safety study of a thrombolytic for HD catheter dysfunction, TROPICS 4 had a sample size large enough to estimate incidence rates of relatively common AEs.…”