TABLE 3

Incidence of on-randomised-treatment adverse events#

FF/UMEC/VINon-ELLIPTA MITT
Patients n (%)Events rate (n)Patients n (%)Events rate (n)
Patients n15451547
Total duration at risk patient-years636.7685.8
Any adverse event250 (16)590.6 (376)151 (10)322.2 (221)
 Any treatment-related adverse event145 (9)329.8 (210)44 (3)77.3 (53)
 Any adverse event leading to study withdrawal115 (7)279.6 (178)32 (2)70.0 (48)
Any SAE114 (7)257.6 (164)114 (7)255.2 (175)
 Any treatment-related SAE13 (<1)20.4 (13)6 (<1)10.2 (7)
Any fatal SAE8 (<1)20.4 (13)8 (<1)23.3 (16)
 Any treatment-related fatal SAE0000
Serious AESIs
 Cardiovascular effects29 (2)55.0 (35)23 (1)39.4 (27)
 Decreased BMD and associated fractures6 (<1)9.4 (6)4 (<1)7.3 (5)
 Infective pneumonia27 (2)44.0 (28)32 (2)46.7 (32)
 LRTI excluding infective pneumonia7 (<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.