Table 4.
Summary of adverse events causally related to treatment with AZD9164
| |
AEs assessed as causally-related to AZD9164 |
||||
|---|---|---|---|---|---|
| |
Placebo |
AZD9164 |
|
||
|
GMAD, healthy subjects |
n = 9 |
400 μg |
1000 μg |
2800 μg |
Total (%) |
| n = 6 | n = 6 | n = 6 | n = 27 | ||
| Dry mouth |
0 |
|
|
1 (16.7) |
1 (3.7) |
| Throat irritation |
0 |
|
|
3 (50.0) |
3 (11.1) |
| Cough |
0 |
|
|
2 (33.3) |
2 (7.4) |
| Flushing |
0 |
|
|
1 (16.7) |
1 (3.7) |
|
JMAD, healthy subjects |
n = 6 |
400 μg |
1000 μg |
|
Total (%) |
| |
|
n = 6 |
n = 6 |
|
n = 18 |
| Rash |
0 |
1 (16.7) |
|
|
1 (5.6) |
| Headache |
0 |
1 (16.7) |
|
|
1 (5.6) |
| Cough |
0 |
1 (16.7) |
1 (16.7) |
|
2 (11.1) |
| Upper respiratory tract infection |
0 |
1 (16.7) |
0 |
|
1 (5.6) |
| Respiratory tract irritation |
0 |
|
1 (16.7) |
|
1 (5.6) |
| Epistaxis |
0 |
|
1 (16.7) |
|
1 (5.6) |
| Nasal mucosal disorder |
0 |
|
1 (16.7) |
|
1 (5.6) |
|
GMAD, COPD patients |
n = 1 |
|
n = 3 |
|
n = 4 |
| Dry mouth |
0 |
|
1 (33.3) |
|
1 (25.0) |
| Palpitations |
0 |
|
1 (33.3) |
|
1 (25.0) |
| Anxiety |
0 |
|
1 (33.3) |
|
1 (25.0) |
| Dyspnoea |
0 |
|
2 (66.6) |
|
2 (50.0) |
| Cough |
0 |
|
1 (33.3) |
|
1 (25.0) |
| Haematoma |
0 |
|
1 (33.3) |
|
1 (25.0) |
| Fatigue | 0 | 1 (33.3) | 1 (25.0) | ||