Table 2.
Omaveloxolone attributable AEs
| Dose, mg | 2.5 | 5 | 10 | 15 | Total | ||||
|---|---|---|---|---|---|---|---|---|---|
| Grade | 1 | 2 | 1 | 2 | 1 | 2 | 1 | 2 | |
| Symptom | |||||||||
| Chronic joint pain | 1 | – | – | – | – | – | – | – | 1 |
| Nausea or vomiting | 1 | – | – | – | – | – | – | – | 1 |
| Vomiting | 1 | – | – | – | – | – | – | – | 1 |
| Papular rash, arm and leg | 1 | – | – | – | – | – | – | – | 1 |
| Chronic leg swelling | 1 | – | – | – | – | – | – | – | 1 |
| Fatigue | 1 | – | – | – | – | – | – | – | 1 |
| Laboratory parameter | |||||||||
| Anemia mean | 2 | – | – | – | – | – | – | – | 1 |
| LDH increased | 1 | – | – | – | – | – | – | – | 1 |
| ALT increased | – | – | – | – | – | 1 | – | – | 1 |
| AST increased | – | – | 1 | – | – | – | – | – | 1 |
| Alkaline phosphatase increased | – | – | 1 | – | 1 | – | – | – | 2 |
Notes: No grade 3 or 4 drug-attributable adverse events were observed. Includes all possible, probable, or definite attributions.
Abbreviations: AEs, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; LDH, lactate dehydrogenase.