Table 2.
Summary of frequency of adverse events across the studies
| |
Placebo |
AZD9164 |
|
|||
|---|---|---|---|---|---|---|
|
GMAD, healthy subjects |
n = 9 |
400 μg |
1000 μg |
2800 μg |
Total (%) |
|
| n = 6 | n = 6 | n = 6 | n = 27 | |||
| Any AEa |
8 (88.9) |
5 (83.3) |
6 (100) |
6 (100) |
25 (92.6) |
|
| SAEsa |
1(11.1) |
0 (0) |
0 (0) |
0 (0) |
1 (3.7) |
|
| DAEsa |
2 (22.2) |
0 (0) |
0 (0) |
0 (0) |
2 (7.4) |
|
| Total number of AEs |
31 |
7 |
18 |
15 |
71 |
|
|
JMAD, healthy subjects |
n = 6 |
400 μg |
1000 μg |
|
Total (%) |
|
| |
|
n = 6 |
n = 6 |
|
n = 18 |
|
| Any AEa |
3 (50.0) |
6 (100.0) |
4 (66.7) |
|
13 (72.2) |
|
| SAEsa |
0 (0) |
0 (0) |
0 (0) |
|
0 (0) |
|
| DAEsa |
0 (0) |
0 (0) |
0 (0) |
|
0 (0) |
|
| Total number of AEs |
3 |
10 |
7 |
|
20 |
|
|
GMAD, COPD patients |
n = 1 |
|
n = 3 |
|
n = 4 |
|
| Any AEa |
1 (100) |
|
3 (100) |
|
4 (100) |
|
| SAEsa |
0 (0) |
|
0 (0) |
|
0 (0) |
|
| DAEsa |
0 (0) |
|
1 (33.3) |
|
1 (25.0) |
|
| Total number of AEs | 1 | 8 | 9 | |||
aNumber (%) of patients who had an AE in each category. Subjects with multiple events in the same category are counted only once in each category.