Overview of TEAEs
| AE outcomes, n (% patients) . | Safety analysis set (N = 19) . |
|---|---|
| AE summary | |
| Any TEAE | 18 (94.7) |
| Any treatment-related SAE | 3 (15.8) |
| Any grade ≥3 treatment-related TEAE | 2 (10.5) |
| Any TEAE leading to ivosidenib discontinuation∗ | 2 (10.5) |
| Any TEAE leading to ivosidenib interruption | 5 (26.3) |
| Any treatment-related TEAE leading to ivosidenib dose modification† | 4 (21.1) |
| TEAEs by preferred term considered possibly or probably related to treatment‡ | |
| Any-grade | 8 (42.1) |
| Fatigue | 3 (15.8) |
| Diarrhea | 2 (10.5) |
| Differentiation syndrome§ | 2 (10.5) |
| Rash | 2 (10.5) |
| Dyspnea | 2 (10.5) |
| ECG QT prolonged‖ | 1 (5.3) |
| Dyspepsia | 1 (5.3) |
| Decreased appetite | 1 (5.3) |
| Skin infection | 1 (5.3) |
| Anemia | 1 (5.3) |
| Platelet count decrease | 1 (5.3) |
| Blood alkaline phosphatase increased | 1 (5.3) |
| Hyponatremia | 1 (5.3) |
| Grade 3 or higher | |
| Fatigue | 1 (5.3) |
| Hyponatremia | 1 (5.3) |
| AE outcomes, n (% patients) . | Safety analysis set (N = 19) . |
|---|---|
| AE summary | |
| Any TEAE | 18 (94.7) |
| Any treatment-related SAE | 3 (15.8) |
| Any grade ≥3 treatment-related TEAE | 2 (10.5) |
| Any TEAE leading to ivosidenib discontinuation∗ | 2 (10.5) |
| Any TEAE leading to ivosidenib interruption | 5 (26.3) |
| Any treatment-related TEAE leading to ivosidenib dose modification† | 4 (21.1) |
| TEAEs by preferred term considered possibly or probably related to treatment‡ | |
| Any-grade | 8 (42.1) |
| Fatigue | 3 (15.8) |
| Diarrhea | 2 (10.5) |
| Differentiation syndrome§ | 2 (10.5) |
| Rash | 2 (10.5) |
| Dyspnea | 2 (10.5) |
| ECG QT prolonged‖ | 1 (5.3) |
| Dyspepsia | 1 (5.3) |
| Decreased appetite | 1 (5.3) |
| Skin infection | 1 (5.3) |
| Anemia | 1 (5.3) |
| Platelet count decrease | 1 (5.3) |
| Blood alkaline phosphatase increased | 1 (5.3) |
| Hyponatremia | 1 (5.3) |
| Grade 3 or higher | |
| Fatigue | 1 (5.3) |
| Hyponatremia | 1 (5.3) |
ECG QT, electrocardiogram QT interval; n, number of patients; SAE, serious AE.
These AEs were grade 5 sepsis and grade 3 fatigue; neither was considered related to ivosidenib.
Modification refers to dose reduction, interruption, or discontinuation.
Six patients experienced multiple treatment-related TEAEs.
One patient experienced 3 differentiation syndrome events (grade 1, 2 events; and grade 2, 1 event) and the other patient experienced 1 grade 2 differentiation syndrome event.
Grade 1 severity.