Table 4 Incidence of on-treatment AEs by treatment group and patient cohort (Safety population)
Incidence of AEs, n/N (%) | |||||
|---|---|---|---|---|---|
Placebo | FF/VI 100/25 μg OD | FF/VI 200/25 μg OD | FF 100 μg OD | FF 200 μg OD | |
Range of treatment duration of studies integrated (weeks) | 8–12 | 12–76 | 24 | 8–76 | 8–24 |
On-treatment All AEs | |||||
Japan + Korea | 12/29 (41) | 37/47 (79)* | 9/14 (64)* | 38/55 (69) | 16/22 (73) |
Not-Japan + Korea | 87/375 (23) | 658/1,163 (57) | 83/183 (45) | 744/1,375 (54) | 134/368 (36) |
Overall | 99/404 (25) | 695/1,210 (57) | 92/197 (47) | 782/1,430 (55) | 150/390 (38) |
On-treatment Drug-Related AEs | |||||
Japan + Korea | 0/29 (0) | 4/47 (9)* | 3/14 (21)* | 1/55 (2) | 2/22 (9) |
Not-Japan + Korea | 6/375 (2) | 79/1,163 (7) | 14/183 (8) | 90/1,375 (7) | 17/368 (5) |
Overall | 6/404 (1) | 83/1,210 (7) | 17/197 (9) | 91/1,430 (6) | 19/390 (5) |
On-treatment AEs Leading to Permanent Discontinuation of Investigative Product or Withdrawal from the Study | |||||
Japan + Korea | 0/29 (0) | 3/47 (6)* | 1/14 (7)* | 2/55 (4) | 1/22 (5) |
Not-Japan + Korea | 1/375 (<1) | 15/1,163 (1) | 6/183 (3) | 21/1,375 (2) | 4/368 (1) |
Overall | 1/404 (<1) | 18/1,210 (1) | 7/197 (4) | 23/1,430 (2) | 5/390 (1) |
On-treatment Non-fatal Serious AEs | |||||
Japan + Korea | 0/29 (0) | 1/47 (2)* | 0/14 (0)* | 1/55 (2) | 0/22 (0) |
Not-Japan + Korea | 0/375 (0) | 39/1,163 (3) | 6/183 (3) | 29/1,375 (2) | 1/368 (<1) |
Overall | 0/404 (0) | 40/1,210 (3) | 6/197 (3) | 30/1,430 (2) | 1/390 (<1) |
On-treatment Fatal AEs | |||||
Japan + Korea | 0/29 (0) | 0/47 (0)* | 0/14 (0)* | 0/55 (0) | 0/22 (0) |
Not-Japan + Korea | 0/375 (0) | 1/1,163 (<1) | 0/183 (0) | 1/1,375 (<1) | 0/368 (0) |
Overall | 0/404 (0) | 1/1,210†(<1) | 0/197 (0) | 1/1,430 (<1) | 0/390 (0) |