Table 4.
Safety (safety population).
| Safety parameter, n (%) | HGG n = 22 | DIPG n = 11 | Ependymoma n = 9 | Medulloblastoma n = 10 |
|---|---|---|---|---|
| Patients with ≥ 1 TEAE related to POM | 14 (63.6) | 5 (45.5) | 7 (77.8) | 8 (80.0) |
| Patients with ≥ 1 grade 3/4 TEAE related to POM | 10 (45.5) | 3 (27.3) | 2 (22.2) | 4 (40.0) |
| Patients with ≥ 1 serious TEAE related to POM | 6 (27.3) | 1 (9.1) | 0 | 0 |
| TEAEs (any grade) related to POM a | ||||
| Neutropenia | 9 (40.9) | 3 (27.3) | 7 (77.8) | 4 (40.0) |
| Leukopenia | 6 (27.3) | 3 (27.3) | 6 (66.7) | 3 (30.0) |
| Lymphopenia | 6 (27.3) | 1 (9.1) | 5 (55.6) | 0 |
| Thrombocytopenia | 6 (27.3) | 0 | 3 (33.3) | 3 (30.0) |
| Anemia | 5 (22.7) | 0 | 3 (33.3) | 2 (20.0) |
| Alanine aminotransferase level increased | 2 (9.1) | 1 (9.1) | 1 (11.1) | 2 (20.0) |
| Constipation | 3 (13.6) | 0 | 1 (11.1) | 2 (20.0) |
| Maculopapular rash | 1 (4.5) | 0 | 3 (33.3) | 2 (20.0) |
| Pruritus | 0 | 2 (18.2) | 2 (22.2) | 1 (10.0) |
| Fatigue | 1 (4.5) | 0 | 1 (11.1) | 2 (20.0) |
| Decreased appetite | 0 | 1 (9.1) | 0 | 2 (20.0) |
| Dry skin | 0 | 1 (9.1) | 2 (22.2) | 0 |
| Vomiting | 1 (4.5) | 0 | 0 | 2 (20.0) |
| Grade 3/4 TEAEs related to POM b | ||||
| Neutropenia | 7 (31.8) | 3 (27.3) | 2 (22.2) | 3 (30.0) |
| Lymphopenia | 2 (9.1) | 1 (9.1) | 0 | 0 |
| Febrile neutropenia | 2 (9.1) | 0 | 0 | 0 |
| Leukopenia | 1 (4.5) | 1 (9.1) | 0 | 0 |
| Thrombocytopenia | 2 (9.1) | 0 | 0 | 0 |
| Hypokalemia | 0 | 0 | 0 | 1 (10.0) |
| Vertigo | 0 | 1 (9.1) | 0 | 0 |
DIPG, diffuse intrinsic pontine glioma; HGG, high-grade glioma; POM, pomalidomide; TEAE, treatment-emergent adverse event.
a
≥ 20% incidence for any tumor type.
b
≥ 5% incidence for any tumor type.