Table 2.
AZD8601 3 mg (n = 7) | Placebo (n = 4) | |
---|---|---|
Any adverse event, n (%) | 7 (100) | 4 (100) |
Related to study druga | 1 (14.3) | 0 (0) |
Fatal adverse event, n (%) | 0 (0) | 0 (0) |
Serious adverse event, n (%)b | 2 (28.6) | 0 (0) |
Related to study drug | 0 (0) | 0 (0) |
Adverse event leading to discontinuation or withdrawal, n (%) | 0 (0) | 0 (0) |
Anemia, n (%)c | 2 (28.6) | 1 (25) |
Atrial fibrillation, n (%)d | 2 (28.6) | 2 (50) |
Coagulopathy, n (%)c | 2 (28.6) | 0 (0) |
Dizziness, n (%)c | 1 (14.3) | 0 (0) |
Dyspepsia, n (%)c | 1 (14.3) | 0 (0) |
Dyspnea, n (%)e | 1 (14.3) | 0 (0) |
Hypotension, n (%)c | 1 (14.3) | 0 (0) |
Nausea, n (%)e | 1 (14.3) | 0 (0) |
Pleural effusion, n (%)c | 0 (0) | 2 (50) |
Procedural pain, n (%)e | 0 (0) | 1 (25) |
Pyrexia, n (%)e | 0 (0) | 1 (25) |
Sinus bradycardia, n (%)e | 1 (14.3) | 0 (0) |
Urinary tract infection, n (%)e | 0 (0) | 1 (25) |
Ventricular arrhythmia, n (%)f | 1 (14.3) | 0 (0) |
Ventricular extrasystoles, n (%)e | 1 (14.3) | 0 (0) |
Ventricular arrhythmia and ventricular extrasystoles before AZD8601 administration in one patient.
Anemia in one patient and coagulopathy in one patient.
Moderate maximum severity.
Moderate maximum intensity in three patients and mild in one (in the AZD8601 group).
Mild maximum intensity.
Severe maximum intensity.