Table 2.
Summary of All Grades and Grades 3‒4 Treatment-emergent Adverse Events Reported for ≥10% of Patients (All Grades) in the Safety Population
| Preferred term*,† | Any grade N = 26 |
Grades 3–4§ N = 26 |
|---|---|---|
| Nausea | 14 (54%) | 1 (4%) |
| Fatigue | 13 (50%) | 0 |
| Alanine aminotransferase increased | 8 (31%) | 3 (12%) |
| Diarrhea | 8 (31%) | 0 |
| Headache | 8 (31%) | 1 (4%) |
| Constipation | 7 (27%) | 0 |
| Fall | 7 (27%) | 0 |
| Aspartate aminotransferase increased | 5 (19%) | 3 (12%) |
| Dysgeusia | 5 (19%) | 0 |
| Seizure | 5 (19%) | 0 |
| Vomiting | 5 (19%) | 1 (4%) |
| Dizziness | 4 (15%) | 0 |
| Hypertension | 4 (15%) | 0 |
| Insomnia | 4 (15%) | 0 |
| Platelet count decreased | 4 (15%) | 1 (4%) |
| Upper respiratory tract infection | 4 (15%) | 0 |
| Aphasia | 3 (12%) | 0 |
| Confusional state | 3 (12%) | 0 |
| Decreased appetite | 3 (12%) | 0 |
| Dyspepsia | 3 (12%) | 0 |
| Epistaxis | 3 (12%) | 0 |
| Hemiparesis | 3 (12%) | 2 (8%) |
| Hypophosphatemia | 3 (12%) | 1 (4%) |
| Muscular weakness | 3 (12%) | 0 |
| Paresthesia | 3 (12%) | 0 |
Data are n (%).
*Safety analysis set was defined as all patients who received any amount of study drug of olutasidenib.
†Per protocol, disease progression was not considered an adverse event when assessed by the Investigator to be unrelated to olutasidenib.
§All listed grade 3‒4 events were grade 3 and considered related to study drug except for headache and hemiparesis.