TABLE 3.
Summary of participants with AEs.
| AZD9567 (n = 11), % | Prednisolone (n = 10), % | |
|---|---|---|
| Any AE | 10 (90.9) | 9 (90.0) |
| Mild | 6 (54.5) | 8 (80.0) |
| Moderate | 3 (27.3) | 1 (10.0) |
| Severe | 1 (9.1) | 0 |
| Any serious AE | 1 (9.1) a | 0 |
| Any treatment‐related AE | 6 (54.5) | 3 (30.0) |
| Any AE leading to discontinuation | 0 | 0 |
| AE by preferred term b | ||
| Abdominal pain (upper) | 2 (18.2) | 0 |
| Cough | 2 (18.2) | 1 (10.0) |
| Dry mouth | 2 (18.2) | 0 |
| Eye pain | 2 (18.2) | 0 |
| Fatigue | 3 (27.3) | 0 |
| Headache | 2 (18.2) | 1 (10.0) |
| Hot flash | 3 (27.3) | 0 |
| Increased appetite | 1 (9.1) | 1 (10.0) |
| Insomnia | 2 (18.2) | 0 |
| Nasopharyngitis | 1 (9.1) | 1 (10.0) |
| Treatment‐related AE by preferred term b | ||
| Abdominal pain (upper) | 2 (18.2) | 0 |
| Dry mouth | 2 (18.2) | 0 |
| Hot flash | 2 (18.2) | 0 |
| Increased appetite | 1 (9.1) | 1 (10.0) |
Note: Data are n (%). Includes AEs that started on or after the date of the first dose, up to and including 14 days after the date of last dose of study treatment (i.e., the follow‐up period).
Abbreviation: AE, adverse event.
a
One event of severe suicidal depression was reported in the AZD9567 group, reported by the patient's physician as related to study treatment.
b
AEs reported by at least two patients overall; patients with multiple events of the same preferred term are counted only once in that preferred term; preferred terms were coded by the Medical Dictionary for Regulatory Activities (MedDRA) version 22.1.