Table 5.
Summary of AEs reported in study 1
| n (%) | AZD1981 (n=57) |
Placebo (n=56) |
|---|---|---|
| Any AE | 29 (51) | 26 (46) |
| AEs reported by ≥2% patients | ||
| Asthma | 5 (9) | 5 (9) |
| Nasopharyngitis | 3 (5) | 7 (13) |
| Increased urinary alpha 1 microglobulin | 2 (4) | 1 (2) |
| Allergic rhinitis | 2 (4) | 0 |
| Pyrexia | 1 (2) | 1 (2) |
| Pharyngitis | 1 (2) | 1 (2) |
| Neurosis | 1 (2) | 1 (2) |
| Diarrhea | 1 (2) | 1 (2) |
| Lower respiratory tract infection | 1 (2) | 1 (2) |
| Headache | 1 (2) | 1 (2) |
| Cough | 1 (2) | 1 (2) |
| Dyspnea | 1 (2) | 1 (2) |
| Dyspepsia | 1 (2) | 1 (2) |
| Conjunctivitis | 0 | 2 (4) |
| Allergic dermatitis | 0 | 2 (4) |
| Anxiety | 0 | 2 (4) |
| Eczema | 2 (4) | 0 |
| Upper respiratory tract infection | 1 (2) | 1 (2) |
| Withdrawals due to AEs | 5 (9) | 7 (13) |
| Severe lower respiratory tract infection | 0 | 1 (2) |
| Asthma | 4a (7) | 4 (7) |
| Drug eruption | 1a (2) | 0 |
| Pneumonia | 0 | 1 (2) |
| Diarrhea | 1 (2) | 0 |
| Allergic dermatitis | 0 | 1 (2) |
| Number of AEs considered causally related to treatmentb | 17 | 3 |
Notes:
a
One case of asthma and drug eruption occurred in the same patient, which led to withdrawal.
b
These numbers refer to the number of AEs (the other categories in this table refer to the number of patients with AEs). Study 1 was a 4-week, randomized, placebo-controlled study that assessed the efficacy and tolerability of a supra-maximal dose of AZD1981 in patients with stable asthma.
Abbreviation: AEs, adverse events.