Adjusted mean differences from PBO (95% CI), safety analysis (intent-to-treat population)
| Change from baseline maximum heart rate (bpm) (0–4 h) | |
| Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40) | 1.4 (–3.1 to 5.9) |
| Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39) | 1.9 (–3.4 to 7.3) |
| Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39) | 3.2 (–2.5 to 8.8) |
| Change from baseline in weighted mean systolic blood pressure (mm Hg) (0–4 h) | |
| Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40) | –0.1 (–5.4 to 5.3) |
| Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39) | –2.2 (–7.9 to 3.4) |
| Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39) | 0.3 (–6.2 to 6.8) |
| Change from baseline in maximum systolic blood pressure (mm Hg) (0–4 h) | |
| Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40) | –1.0 (–7.4 to 5.5) |
| Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39) | –2.9 (–9.0 to 3.3) |
| Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39) | 0.9 (–5.9 to 7.8) |
| Change from baseline in weighted mean diastolic blood pressure (mm Hg) (0–4 h) | |
| Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40) | –2.1 (–4.6 to 0.4) |
| Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39) | –3.6 (−6.7 to −0.5) |
| Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39) | –1.4 (–5.1 to 2.4) |
| Change from baseline in minimum diastolic blood pressure (mm Hg) (0–4 h) | |
| Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40) | –2.3 (−5.2 to 0.6) |
| Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39) | –5.2 (−8.8 to −1.6) |
| Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39) | –2.7 (–7.4 to 1.9) |
Population sizes for each day and each time point relate to the number of patients with analysable data at the given time point.
bpm, beats per minute; FF, fluticasone furoate; PBO, placebo; VI, vilanterol.