Table 7.
On-treatment adverse events reported by ≥3% of patients within any treatment group (mITT population)
| |
Number (%) of patients |
||||
|---|---|---|---|---|---|
|
Preferred term |
|
UMEC QD |
|||
| |
Placebo |
15.6 μg |
31.25 μg |
62.5 μg |
125 μg |
| N = 60 | N = 60 | N = 57 | N = 59 | N = 60 | |
| Headache |
2 (3) |
1 (2) |
0 |
0 |
3 (5) |
| Nasopharyngitis |
0 |
1 (2) |
0 |
0 |
1 (2) |
| Dysgeusia |
0 |
1 (2) |
0 |
0 |
2 (3) |
| Sinusitis |
0 |
0 |
0 |
0 |
2 (3) |
|
Preferred term |
UMEC BID |
Tiotropium |
|||
| |
15.6 μg |
31.25 μg |
QD 18 μg |
||
| |
N = 56 |
N = 58 |
N = 56 |
||
| Headache |
4 (7) |
1 (2) |
0 |
||
| Nasopharyngitis |
0 |
0 |
2 (4) |
||
| Dysgeusia |
0 |
0 |
0 |
||
| Sinusitis | 0 | 0 | 0 | ||
Cut-off of ≥3% was based on percentage after rounding; on-treatment AEs were defined as AEs with onset within the period beginning with the first day of study drug administration through the day after the last day of study drug administration.
BID, twice daily; mITT, modified intent-to-treat; QD, once daily; UMEC, umeclidinium bromide.