TABLE 3.
Adverse event profile of AK0529 compared with placebo.
AK0529 (N = 49), n (%) | Placebo (N = 24), n (%) | Total (N = 73), n (%) | |
---|---|---|---|
Subjects with any AEs | 25 (51.0%) | 10 (41.7%) | 35 (47.9%) |
Subjects with any TEAEs | 24 (49.0%) | 10 (41.7%) | 34 (46.6%) |
Subjects with any drug related TEAEs | 3 (6.1%) a | 0 | 3 (4.1%) |
Subjects with any serious TEAEs | 2 (4.1%) b | 0 | 2 (2.7%) |
Subjects with any TEAEs induced withdrawal | 0 | 0 | 0 |
Subjects with any grade ≥3 TEAEs | 2 (4.1%) c | 1 (4.2%) d | 3 (4.1%) |
Subjects with any TEAEs leading to death | 0 | 0 | 0 |
Abbreviations: AEs, adverse events; SAEs, serious adverse events; TEAEs, treatment‐emergent adverse events.
One case each of increased aspartate aminotransferase, increased transaminases, hyperkalemia.
Two cases of unrelated pneumonia.
One case of pneumonia, classified as SAE; one case of elevated transaminase.
One case of pneumonia.