Table 5 Overall safety outcomes (ITT population)
Study 207608 | Study 207609 | |||||||
|---|---|---|---|---|---|---|---|---|
FF/UMEC/VI N = 363 | BUD/FOR+TIO N = 365 | FF/UMEC/VI N = 366 | BUD/FOR+TIO N = 366 | |||||
n (%) | Rate [#] | n (%) | Rate [#] | n (%) | Rate [#] | n (%) | Rate [#] | |
AEs | ||||||||
Any | 131 (36) | 2932.8 [244] | 121 (33) | 2651.8 [216] | 92 (25) | 2488.8 [205] | 109 (30) | 2321.2 [192] |
Drug-related | 23 (6) | 372.6 [31] | 16 (4) | 233.3 [19] | 9 (2) | 182.1 [15] | 10 (3) | 145.1 [12] |
Leading to permanent discontinuation or withdrawal | 7 (2) | 132.2 [11] | 7 (2) | 85.9 [7] | 2 (< 1) | 24.3 [2] | 5 (1) | 60.4 [5] |
SAEs | ||||||||
Any | 25 (7) | 444.7 [37] | 14 (4) | 221.0 [18] | 12 (3) | 279.2 [23] | 17 (5) | 266.0 [22] |
Drug-related | 4 (1) | 60.1 [5] | 0 | 1 (< 1) | 24.3 [2] | 1 (< 1) | 12.1 [1] | |
Leading to permanent discontinuation or withdrawal | 5 (1) | 96.2 [8] | 5 (1) | 61.4 [5] | 1 (< 1) | 12.1 [1] | 4 (1) | 48.4 [4] |
Fatal | 0 | 0 | 0 | 1 (< 1) | 12.1 [1] | |||
AESIs | ||||||||
Cardiovascular effects | 10 (3) | 132.2 [11] | 8 (2) | 135.0 [11] | 11 (3) | 157.8 [13] | 8 (2) | 120.9 [10] |
Decreased BMD and associated fractures | 5 (1) | 72.1 [6] | 3 (< 1) | 36.8 [3] | 2 (< 1) | 36.4 [3] | 4 (1) | 48.4 [4] |
LRTI excluding pneumonia | 9 (2) | 108.2 [9] | 1 (< 1) | 12.3 [1] | 1 (< 1) | 12.1 [1] | 1 (< 1) | 12.1 [1] |
Pneumonia | 5 (1) | 60.1 [5] | 6 (2) | 73.7 [6] | 2 (< 1) | 24.3 [2] | 3 (< 1) | 60.4 [5] |