Table 2.
Treatment-emergent adverse event (TEAE).
| System organ class | PlaceboN=9 | Foralumab (10ug) N=6 | Foralumab (50ug) N=6 | Foralumab (250ug) N=6 | Foralumab-all doses N=18 |
|---|---|---|---|---|---|
| Subjects with at least one TEAE | 2 | 5 | 5 | 2 | 12 |
| Number of TEAEs by severity | 3 | 15 | 9 | 3 | 27 |
| Severity | 27 | ||||
| Non-serious | 3 | 15 | 9 | 3 | 27 |
| Serious | 0 | 0 | 0 | 0 | 0 |
| Ear and labyrinth disorders | 3 | ||||
| Non-serious | 0 | 2 | 1 | 0 | 3 |
| Serious | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal disorders | 2 | ||||
| Non-serious | 0 | 0 | 2 | 0 | 2 |
| Serious | 0 | 0 | 0 | 0 | 0 |
| Immune system disorder | 1 | ||||
| Non-serious | 0 | 0 | 1 | 0 | 1 |
| Serious | 0 | 0 | 0 | 0 | 0 |
| Infections and infestations | 9 | ||||
| Non-serious | 0 | 8 | 0 | 1 | 9 |
| Serious | 0 | 0 | 0 | 0 | 0 |
| Injury, poisoning and procedural complications | 1 | ||||
| Non-serious | 0 | 1 | 0 | 0 | 1 |
| Serious | 0 | 0 | 0 | 0 | 0 |
| Nervous system disorders | 6 | ||||
| Non-serious | 0 | 3 | 2 | 1 | 6 |
| Serious | 0 | 0 | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorder | 5 | ||||
| Non-serious | 3 | 1 | 3 | 1 | 5 |
| Serious | 0 | 0 | 0 | 0 | 0 |
Bold values are p<0.05.