| FF/VI 100/25 μg | FP/SAL 500/50 μg | |
| Subjects n | 266 | 262 |
| Summary | ||
| Any on-treatment adverse events | 73 (27) | 68 (26) |
| Adverse events leading to permanent discontinuation from the study or withdrawal of study treatment | 6 (2) | 3 (1) |
| Any on-treatment severe adverse events | 6 (2) | 3 (1) |
| Drug-related adverse events# | 4 (2) | 9 (3) |
| Adverse events of special interest (special interest term) | ||
| Cardiovascular effects | 9 (3)¶ | 1 (<1) |
| Hypertension | 2 (<1) | 1 (<1) |
| Atrial fibrillation | 2 (<1) | 0 |
| Tachycardia | 2 (<1) | 0 |
| Angina pectoris | 1 (<1) | 0 |
| Bradycardia | 1 (<1) | 0 |
| Coronary artery disease | 1 (<1) | 0 |
| Oedema peripheral | 1 (<1) | 0 |
| Local steroid effects | 3 (1) | 10 (4)§ |
| Oral candidiasis | 2 (<1)+ | 4 (2)ƒ |
| Oropharyngeal candidiasis | 0 | 3 (1)+ |
| Oropharyngeal pain | 0 | 3 (1) |
| Dysphonia | 1 (<1)+ | 1 (<1)+ |
| Hypersensitivity | 2 (<1) | 2 (<1) |
| LRTI excluding pneumonia | 2 (<1) | 0 |
| Pneumonia | 1 (<1) | 2 (<1) |
| Ocular effects | 1 (<1) | 1 (<1) |
| Tremor | 1 (<1)+ | 0 |
| Effects on glucose | 0 | 2 (<1)## |
| Bone disorders | 0 | 1 (<1) |
| On-treatment adverse events occurring in ≥2% of patients in any treatment group | ||
| Headache | 20 (8) | 18 (7) |
| Nasopharyngitis | 8 (3) | 12 (5) |
| Back pain | 10 (4) | 3 (1) |
| Cough | 3 (1) | 7 (3) |
| Oral candidiasis | 2 (<1) | 4 (2) |
Data are presented as n (%). FF: fluticasone furoate; VI: vilanterol trifenatate; FP: fluticasone propionate; SAL: salmeterol; LRTI: lower respiratory tract infection. #: as determined by the investigator; ¶: one subject had angina pectoris and coronary artery disease; +: all events were considered drug-related; §: one subject had dysphonia and oral candidiasis; ƒ: three out of the four events were considered drug-related; ##: one out of of the two events was considered drug-related.