Summary of TEAEs occurring in ≥20% of patients and grade ≥3 events regardless of relation to valemetostat treatment
| All AEs . | ||
|---|---|---|
| AE type . | N = 25, n (%) . | |
| TEAEs | 25 (100.0) | |
| TRAEs | 24 (96.0) | |
| Serious TEAE∗ | 8 (32.0) | |
| Serious TRAEs | 7 (28.0) | |
| Grade ≥3 TEAEs | 15 (60.0) | |
| Grade ≥3 TRAEs | 14 (56.0) | |
| TEAEs leading to reduction | 2 (8.0) | |
| TRAEs leading to reduction | 2 (8.0) | |
| TEAEs leading to interruption | 5 (20.0) | |
| TRAEs leading to interruption | 4 (16.0) | |
| TEAEs leading to discontinuation | 2 (8.0) | |
| TRAEs leading to discontinuation | 2 (8.0) | |
| All AEs . | ||
|---|---|---|
| AE type . | N = 25, n (%) . | |
| TEAEs | 25 (100.0) | |
| TRAEs | 24 (96.0) | |
| Serious TEAE∗ | 8 (32.0) | |
| Serious TRAEs | 7 (28.0) | |
| Grade ≥3 TEAEs | 15 (60.0) | |
| Grade ≥3 TRAEs | 14 (56.0) | |
| TEAEs leading to reduction | 2 (8.0) | |
| TRAEs leading to reduction | 2 (8.0) | |
| TEAEs leading to interruption | 5 (20.0) | |
| TRAEs leading to interruption | 4 (16.0) | |
| TEAEs leading to discontinuation | 2 (8.0) | |
| TRAEs leading to discontinuation | 2 (8.0) | |
| Most common TEAEs . | ||
|---|---|---|
| Hematologic | All grades (≥20%), n (%) | Grade ≥3, n (%) |
| Thrombocytopenia† | 20 (80.0) | 8 (32.0) |
| Anemia‡ | 13 (52.0) | 8 (32.0) |
| Neutropenia§ | 7 (28.0) | 3 (12.0) |
| Lymphopenia|| | 6 (24.0) | 4 (16.0) |
| Leukopenia¶ | 5 (20.0) | 3 (12.0) |
| Nonhematologic | All grades (≥20%), n (%) | Grade ≥3, n (%) |
| Alopecia | 10 (40.0) | 0 |
| Dysgeusia | 9 (36.0) | 0 |
| Decreased appetite | 5 (20.0) | 2 (8.0) |
| Pyrexia | 5 (20.0) | 0 |
| Most common TEAEs . | ||
|---|---|---|
| Hematologic | All grades (≥20%), n (%) | Grade ≥3, n (%) |
| Thrombocytopenia† | 20 (80.0) | 8 (32.0) |
| Anemia‡ | 13 (52.0) | 8 (32.0) |
| Neutropenia§ | 7 (28.0) | 3 (12.0) |
| Lymphopenia|| | 6 (24.0) | 4 (16.0) |
| Leukopenia¶ | 5 (20.0) | 3 (12.0) |
| Nonhematologic | All grades (≥20%), n (%) | Grade ≥3, n (%) |
| Alopecia | 10 (40.0) | 0 |
| Dysgeusia | 9 (36.0) | 0 |
| Decreased appetite | 5 (20.0) | 2 (8.0) |
| Pyrexia | 5 (20.0) | 0 |
TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.
Acute kidney injury, cardiac failure, cytomegalovirus chorioretinitis, cytomegalovirus infection reactivation, febrile neutropenia, hepatic function abnormal, hypercalcemia, lower gastrointestinal hemorrhage, overdose, thrombocytopenia, pneumonia, and venous thrombosis limb occurred in 1 patient each.
Encompasses the preferred terms: thrombocytopenia and platelet count decreased.
Encompasses the preferred terms: anemia, hemoglobin decreased, hematocrit decreased, and red blood cell count decreased.
Encompasses the preferred terms: neutropenia and neutrophil count decreased.
Encompasses the preferred terms: lymphopenia and lymphocyte count decreased.
Encompasses the preferred terms: leukopenia and white blood cell count decreased.