Table 2.
Overview of AEs and the most common (≥3%) on-treatment AEs and the most common (≥2%) treatment-related AEs (intent-to-treat population)
| FF/VI 100/25 µg OD (N=201) |
FF/VI 200/25 µg OD (N=202) |
FP 50 µg BD (N=100) |
|
|---|---|---|---|
| Any on-treatment AE | 139 (69) | 134 (66) | 73 (73) |
| Headache | 39 (19) | 35 (17) | 23 (23) |
| Upper RTI | 34 (17) | 30 (15) | 18 (18) |
| Nasopharyngitis | 25 (12) | 19 (9) | 10 (10) |
| Cough | 9 (4) | 11 (5) | 13 (13) |
| Oropharyngeal pain | 7 (3) | 12 (6) | 11 (11) |
| Pyrexia | 8 (4) | 13 (6) | 6 (6) |
| Oral/oropharyngeal candidiasis | 15 (7) | 13 (6) | 3 (3) |
| Back pain | 8 (4) | 13 (6) | 3 (3) |
| Extrasystoles* | 4 (2) | 15 (7) | 3 (3) |
| Bronchitis | 7 (3) | 9 (4) | 5 (5) |
| Upper abdominal pain | 8 (4) | 11 (5) | 1 (1) |
| RTI | 6 (3) | 5 (2) | 7 (7) |
| Sinusitis | 9 (4) | 4 (2) | 5 (5) |
| Dysphonia | 8 (4) | 6 (3) | 3 (3) |
| Diarrhoea | 7 (3) | 6 (3) | 2 (2) |
| Allergic rhinitis | 7 (3) | 4 (2) | 2 (2) |
| Toothache | 6 (3) | 5 (2) | 2 (2) |
| Rhinitis | 4 (2) | 6 (3) | 1 (1) |
| Myalgia | 5 (2) | 2 (<1) | 3 (3) |
| Ear pain | 0 | 1 (<1) | 3 (3) |
| Tension headache | (<1) | 0 | 3 (3) |
| Any treatment-related AE†‡ | 27 (13) | 29 (14) | 14 (14) |
| Oral/oropharyngeal candidiasis | 11 (5) | 9 (4) | 2 (2) |
| Dysphonia | 6 (3) | 2 (<1) | 0 |
| Extrasystoles | 1 (<1) | 5 (2) | 0 |
| Cough | 3 (1) | 0 | 2 (2) |
| AEs leading to withdrawal from the study‡ | 5 (2) | 3 (1) | 6 (6) |
| Any on-treatment SAE | 3 (1)§ | 1 (<1)¶ | 7 (7)** |
| Any treatment-related SAE | 0 | 0 | 1 (1) |
| Deaths | 0 | 0 | 0 |
Values are n (%).
*Bigeminy or trigeminy on Holter recording.
†Investigator's judgment of causality.
‡Includes on-treatment and post-treatment AEs.
§Myalgia (muscular chest pain), haemorrhagic dengue fever, asthma exacerbation.
¶Acute pyelonephritis.
**Pneumonia, deep vein thrombosis, asthma exacerbation (n=2), fibroadenoma of breast, breast cancer, worsening of hepatitis B (worsening hepatitis B considered by investigator to be treatment-related).
AE, adverse event; BD, twice daily; FF, fluticasone furoate; FP, fluticasone propionate; OD, once daily; RTI, respiratory tract infection; SAE, serious AE; VI, vilanterol.