Table 3 Summary of TEAEs (safety population)
BGF 320/14.4/10 µg | GFF 14.4/10 µg | BFF 320/10 µg | BUD/FORM 400/12 µg | |||||
|---|---|---|---|---|---|---|---|---|
Non-reversible and EOS < 300b (n = 319) | Overall population (n = 639) | Non-reversible and EOS < 300b (n = 315) | Overall population (n = 625) | Non-reversible and EOS < 300b (n = 161) | Overall population (n = 314) | Non-reversible and EOS < 300b (n = 153) | Overall population (n = 318) | |
TEAEs, n (%) | ||||||||
≥ 1 TEAE | 189 (59.2) | 388 (60.7) | 192 (61.0) | 384 (61.4) | 85 (52.8) | 175 (55.7) | 85 (55.6) | 183 (57.5) |
Treatment-related TEAEsa | 51 (16.0) | 112 (17.5) | 51 (16.2) | 91 (14.6) | 20 (12.4) | 48 (15.3) | 17 (11.1) | 40 (12.6) |
TEAEs that led to early discontinuation | 20 (6.3) | 30 (4.7) | 16 (5.1) | 30 (4.8) | 7 (4.3) | 11 (3.5) | 2 (1.3) | 11 (3.5) |
Serious TEAEs | 27 (8.5) | 55 (8.6) | 36 (11.4) | 68 (10.9) | 10 (6.2) | 21 (6.7) | 9 (5.9) | 29 (9.1) |
Serious TEAEs relateda to study treatment | 4 (1.3) | 7 (1.1) | 10 (3.2) | 12 (1.9) | 2 (1.2) | 3 (1.0) | 1 (0.7) | 6 (1.9) |
Serious TEAEs that led to early discontinuation | 7 (2.2) | 14 (2.2) | 11 (3.5) | 22 (3.5) | 3 (1.9) | 6 (1.9) | 1 (0.7) | 10 (3.1) |
Deaths (all causes) | 2 (0.6) | 6 (0.9) | 1 (0.3) | 3 (0.5) | 1 (0.6) | 2 (0.6) | 0 | 1 (0.3) |
TEAEs occurring in ≥ 2% of patients with non-reversible airways and EOS < 300b in any treatment arm, preferred term, n (%) | ||||||||
Nasopharyngitis | 28 (8.8) | 49 (7.7) | 17 (5.4) | 41 (6.6) | 11 (6.8) | 26 (8.3) | 16 (10.5) | 30 (9.4) |
Upper respiratory tract infection | 28 (8.8) | 65 (10.2) | 24 (7.6) | 38 (6.1) | 8 (5.0) | 18 (5.7) | 7 (4.6) | 22 (6.9) |
COPD | 11 (3.4) | 17 (2.7) | 20 (6.3) | 32 (5.1) | 6 (3.7) | 8 (2.5) | 4 (2.6) | 13 (4.1) |
Bronchitis | 9 (2.8) | 20 (3.1) | 8 (2.5) | 15 (2.4) | 7 (4.3) | 12 (3.8) | 8 (5.2) | 9 (2.8) |
Dysphonia | 8 (2.5) | 20 (3.1) | 3 (1.0) | 5 (0.8) | 6 (3.7) | 15 (4.8) | 4 (2.6) | 6 (1.9) |
Hypertension | 8 (2.5) | 13 (2.0) | 5 (1.6) | 10 (1.6) | 4 (2.5) | 8 (2.5) | 3 (2.0) | 4 (1.3) |
Muscle spasms | 11 (3.4) | 21 (3.3) | 1 (0.3) | 8 (1.3) | 4 (2.5) | 17 (5.4) | 4 (2.6) | 6 (1.9) |
Pneumonia | 9 (2.8) | 12 (1.9) | 3 (1.0) | 10 (1.6) | 3 (1.9) | 6 (1.9) | 2 (1.3) | 4 (1.3) |
Back pain | 1 (0.3) | 8 (1.3) | 9 (2.9) | 12 (1.9) | 2 (1.2) | 4 (1.3) | 4 (2.6) | 8 (2.5) |
Urinary tract infection | 7 (2.2) | 12 (1.9) | 5 (1.6) | 10 (1.6) | 1 (0.6) | 4 (1.3) | 3 (2.0) | 4 (1.3) |
Dyspnea | 7 (2.2) | 9 (1.4) | 4 (1.3) | 9 (1.4) | 1 (0.6) | 8 (2.5) | 1 (0.7) | 8 (2.5) |
Oral candidiasis | 4 (1.3) | 10 (1.6) | 4 (1.3) | 5 (0.8) | 4 (2.5) | 5 (1.6) | 2 (1.3) | 5 (1.6) |
Pharyngitis | 4 (1.3) | 8 (1.3) | 2 (0.6) | 5 (0.8) | 5 (3.1) | 5 (1.6) | 2 (1.3) | 3 (0.9) |
Herpes zoster | 0 | 1 (0.2) | 1 (0.3) | 3 (0.5) | 1 (0.6) | 2 (0.6) | 3 (2.0) | 3 (0.9) |