Table 2.
Summary of adverse events in the double-blind phase
Adverse events | Placebo group (n = 15) | PBT2 group (n = 27, includes 2 withdrawals) |
---|---|---|
One of more AE | 15 | 26 |
Related AE | 10 | 23 |
Serious AE | 4 | 3 |
Death | 0 | 1 |
Nature of AE reported by ≥ 2 participants | ||
Cardiac | 2 | 1 |
Ear | 2 | 0 |
Eye | 5 | 10 |
Gastrointestinal | 8 | 7 |
General | 0 | 5 |
Immune system | 1 | 3 |
Infection | 11 | 14 |
Injury | 1 | 2 |
Investigational | 1 | 4 |
Metabolic | 3 | 2 |
Musculoskeletal | 4 | 6 |
Neoplasia | 0 | 2 |
Nervous system | 6 | 17 |
Respiratory | 1 | 4 |
Skin | 2 | 8 |
Abbreviation: AE, adverse event.