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.