Table 4.
Treatment-emergent adverse events during the 52-week treatment period (SAF-Modified-1)
| Participantsa | FF/UMEC/VI (N = 632) |
ICS/LABA (N = 604) |
Overall population (N = 1236) |
|---|---|---|---|
| n/632 (%) | n/604 (%) | n/1236 (%) | |
| Any TEAEb | 58 (9.2) | 31 (5.1) | 89 (7.2) |
| Respiratory, thoracic, and mediastinal disorders | 28 (4.4) | 9 (1.5) | 37 (3.0) |
| Infections and infestations | 12 (1.9) | 3 (0.5) | 15 (1.2) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 7 (1.1) | 4 (0.7) | 11 (0.9) |
| Gastrointestinal disorders | 5 (0.8) | 2 (0.3) | 7 (0.6) |
| General disorders and administration site conditions | 2 (0.3) | 2 (0.3) | 4 (0.3) |
| Hepatobiliary disorders | 2 (0.3) | 0 | 2 (0.2) |
| Musculoskeletal and connective tissue disorders | 2 (0.3) | 0 | 2 (0.2) |
| Nervous system disorders | 2 (0.3) | 2 (0.3) | 4 (0.3) |
| Blood and lymphatic system disorders | 1 (0.2) | 0 | 1 (0.1) |
| Cardiac disorders | 1 (0.2) | 2 (0.3) | 3 (0.2) |
| Injury, poisoning, and procedural complications | 1 (0.2) | 3 (0.5) | 4 (0.3) |
| Investigations—sputum abnormal | 1 (0.2) | 0 | 1 (0.1) |
| Pregnancy, puerperium, and perinatal conditions | 1 (0.2) | 1 (0.2) | 2 (0.2) |
| Psychiatric disorders | 1 (0.2) | 1 (0.2) | 2 (0.2) |
| Skin and subcutaneous tissue disorders | 1 (0.2) | 1 (0.2) | 2 (0.2) |
| Congenital, familial, and genetic disorders | 0 | 1 (0.2) | 1 (0.1) |
| Any trial intervention/treatment-related TEAEc | 42 (6.6) | 15 (2.5) | 57 (4.6) |
| Respiratory, thoracic, and mediastinal disorders | 24 (3.8) | 8 (1.3) | 32 (2.6) |
| Infections and infestations | 9 (1.4) | 1 (0.2) | 10 (0.8) |
| Gastrointestinal disorders | 4 (0.6) | 0 | 4 (0.3) |
| General disorders and administration site conditions | 2 (0.3) | 1 (0.2) | 3 (0.2) |
| Nervous system disorders | 2 (0.3) | 2 (0.3) | 4 (0.3) |
| Injury, poisoning, and procedural complications | 1 (0.2) | 0 | 1 (0.1) |
| Investigations—sputum abnormal | 1 (0.2) | 0 | 1 (0.1) |
| Psychiatric disorders | 1 (0.2) | 0 | 1 (0.1) |
| Skin and subcutaneous tissue disorders | 1 (0.2) | 1 (0.2) | 2 (0.2) |
| Cardiac disorders | 0 | 2 (0.3) | 2 (0.2) |
| Any serious TEAE | 22 (3.5) | 16 (2.6) | 38 (3.1) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 7 (1.1) | 4 (0.7) | 11 (0.9) |
| Infections and infestations | 4 (0.6) | 2 (0.3) | 6 (0.5) |
| Respiratory, thoracic, and mediastinal disorders | 4 (0.6) | 1 (0.2) | 5 (0.4) |
| Hepatobiliary disorders | 2 (0.3) | 0 | 2 (0.2) |
| Musculoskeletal and connective tissue disorders | 2 (0.3) | 0 | 2 (0.2) |
| Blood and lymphatic system disorders | 1 (0.2) | 0 | 1 (0.1) |
| Cardiac disorders | 1 (0.2) | 0 | 1 (0.1) |
| Gastrointestinal disorders | 1 (0.2) | 2 (0.3) | 3 (0.2) |
| Pregnancy, puerperium, and perinatal conditions | 1 (0.2) | 1 (0.2) | 2 (0.2) |
| Congenital, familial, and genetic disorders | 0 | 1 (0.2) | 1 (0.1) |
| General disorders and administration site conditions | 0 | 1 (0.2) | 1 (0.1) |
| Injury, poisoning, and procedural complications | 0 | 3 (0.5) | 3 (0.2) |
| Psychiatric disorders | 0 | 1 (0.2) | 1 (0.1) |
| Any trial intervention/treatment-related serious TEAE | 1 (0.2) | 0 | 1 (0.1) |
| Infections and infestations | 1 (0.2) | 0 | 1 (0.1) |
| Any CV event | 6 (0.9) | 0 | 6 (0.5) |
| TEAEs leading to trial intervention withdrawal/interruption | 21 (3.3) | 5 (0.8) | 26 (2.1) |
| TEAEs leading to death | 1 (0.2) | 2 (0.3) | 3 (0.2) |
AE adverse event, CV cardiovascular, FF fluticasone furoate, ICS inhaled corticosteroid, LABA long-acting β2-agonist, SAE serious adverse event, TEAE treatment-emergent adverse event, UMEC umeclidinium, VI vilanterol
aAll randomized participants who received ≥ 1 prescription of FF/UMEC/VI or ICS/LABA assessed according to actual trial intervention prescribed (primary safety analysis)
bDefined as any AE (trial intervention/treatment-related AEs and all SAEs) with onset dates on or after the start of the trial intervention and up to 7 days after the last dose of trial intervention
cIncluding trial intervention/treatment-related AEs and trial intervention/treatment-related SAEs