Table 7. Safety results for studies 1 (CTT116415) and 2 (200587)a.
Study 1 | FF/UMEC/VI (n = 43) | UMEC/VI (n = 41) | FF/VI (n = 42) | FF/UMEC (n = 43) | Total (n = 44) |
Any AEs, n (%) | 4 (9) | 6 (15) | 6 (14) | 3 (7)b | 16 (36) |
Study 2 | FF/UMEC(500)/VI (n = 44) | FF/UMEC(250)/VI (n = 43) | FF/VI (n = 43) | UMEC(250)/VI (n = 43) | Total (n = 44) |
Any AEs, n (%) | 2 (5) | 3 (7) | 1 (2) | 0 | 6 (14) |
aSubjects who experienced at least 1 AE. bIn 1 subject, 1 of these AEs was identified as SAE (type 2 diabetes mellitus) resulting in the subject being withdrawn from the study. AE = adverse event; SAE = serious adverse event.