Table 3.
On-treatment adjudicated deaths in the Asia and non-Asia region
| FF/UMEC/VI | FF/VI | UMEC/VI | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Asia | Non-Asia | Asia | Non-Asia | Asia | Non-Asia | |||||||
| Total duration at risk (patient-years) | 617.0 | 3163.6 | 591.3 | 2932.0 | 293.3 | 1437.6 | ||||||
| Patients, n (%) | Rate [#] | Patients, n (%) | Rate [#] | Patients, n (%) | Rate [#] | Patients, n (%) | Rate [#] | Patients, n (%) | Rate [#] | Patients, n (%) | Rate [#] | |
| Adjudicated on-treatment deathsa | 8 (1) | 13.0 [8] | 42 (1) | 13.3 [42] | 10 (2) | 16.9 [10] | 39 (1) | 13.3 [39] | 6 (2) | 20.5 [6] | 33 (2) | 23.0 [33] |
| Cardiovascular | 3 (< 1) | 4.9 [3] | 13 (< 1) | 4.1 [13] | 4 (< 1) | 6.8 [4] | 17 (< 1) | 5.8 [17] | 2 (< 1) | 6.8 [2] | 13 (< 1) | 9.0 [13] |
| Respiratory | 2 (< 1) | 3.2 [2] | 13 (< 1) | 4.1 [13] | 5 (< 1) | 8.5 [5] | 7 (< 1) | 2.4 [7] | 2 (< 1) | 6.8 [2] | 7 (< 1) | 4.9 [7] |
| Adjudicated pneumonia-related deaths† | 1 (< 1) | 1.6 [1] | 6 (< 1) | 1.9 [6] | 2 (< 1) | 3.4 [2] | 0 | 0 | 2 (< 1) | 6.8 [2] | 2 (< 1) | 1.4 [2] |
| Cancer | 0 | 0 | 4 (< 1) | 1.3 [4] | 0 | 0 | 4 (< 1) | 1.4 [4] | 1 (< 1) | 3.4 [1] | 1 (< 1) | 0.7 [1] |
| Unknown | 2 (< 1) | 3.2 [2] | 9 (< 1) | 2.8 [9] | 1 (< 1) | 1.7 [1] | 7 (< 1) | 2.4 [7] | 1 (< 1) | 3.4 [1] | 10 (< 1) | 7.0 [10] |
| Other | 1 (< 1) | 1.6 [1] | 3 (< 1) | 0.9 [3] | 0 | 0 | 4 (< 1) | 1.4 [4] | 0 | 0 | 2 (< 1) | 1.4 [2] |
COPD chronic obstructive pulmonary disease, FF fluticasone furoate, RTI respiratory tract infection, UMEC umeclidinium, VI vilanterol
aFatal serious adverse reports that are categorized by the adjudicators based on the primary cause of death; †Primary cause of death adjudicated as COPD exacerbation with evidence of pneumonia or pneumonia/RTI without COPD exacerbation. Rate is event rate per 1000 patient-years; #: number of events. On-treatment deaths are those which occur between study treatment start date and 7 days after study treatment stop date, inclusive