FF/UMEC/VI | Non-ELLIPTA MITT | |||
Patients n (%) | Events rate¶ (n) | Patients n (%) | Events rate¶ (n) | |
Patients n | 1545 | 1547 | ||
Total duration at risk patient-years | 636.7 | 685.8 | ||
Any adverse event | 250 (16) | 590.6 (376) | 151 (10) | 322.2 (221) |
Any treatment-related adverse event | 145 (9) | 329.8 (210) | 44 (3) | 77.3 (53) |
Any adverse event leading to study withdrawal | 115 (7) | 279.6 (178) | 32 (2) | 70.0 (48) |
Any SAE | 114 (7) | 257.6 (164) | 114 (7) | 255.2 (175) |
Any treatment-related SAE | 13 (<1) | 20.4 (13) | 6 (<1) | 10.2 (7) |
Any fatal SAE | 8 (<1) | 20.4 (13) | 8 (<1) | 23.3 (16) |
Any treatment-related fatal SAE | 0 | 0 | 0 | 0 |
Serious AESIs | ||||
Cardiovascular effects | 29 (2) | 55.0 (35) | 23 (1) | 39.4 (27) |
Decreased BMD and associated fractures | 6 (<1) | 9.4 (6) | 4 (<1) | 7.3 (5) |
Infective pneumonia | 27 (2) | 44.0 (28) | 32 (2) | 46.7 (32) |
LRTI excluding infective pneumonia | 7 (<1) | 11.0 (7) | 10 (<1) | 14.6 (10) |
FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol; MITT: multiple-inhaler triple therapy; SAE: serious adverse event; AESI: adverse event of special interest; BMD: bone mineral density; LRTI: lower respiratory tract infection. #: the recording of adverse events was limited to treatment-related adverse events, SAEs and adverse events leading to study treatment discontinuation or study withdrawal. Refer to supplementary tables S6 and S7 for further details; ¶: event rate per 1000 patient-years, calculated as number of events × 1000, divided by the total duration at risk.