Table 2.
Treatment-emergent AEs
| TEAE* | Itacitinib, n (%) | |||
|---|---|---|---|---|
| 200 mg (n = 14) | 300 mg (n = 15) | |||
| Grade 3/4 | All grades | Grade 3/4 | All grades | |
| Nonhematologic | ||||
| Diarrhea† | 4 (28.6) | 8 (57.1) | 2 (13.3) | 6 (40.0) |
| Peripheral edema | 0 (0) | 4 (28.6) | 1 (6.7) | 9 (60.0) |
| Abdominal pain | 2 (14.3) | 6 (42.9) | 1 (6.7) | 5 (33.3) |
| Hypokalemia | 4 (28.6) | 6 (42.9) | 3 (20.0) | 5 (33.3) |
| Hyperglycemia | 3 (21.4) | 6 (42.9) | 4 (26.7) | 4 (26.7) |
| Fatigue | 4 (28.6) | 4 (28.6) | 0 (0) | 5 (33.3) |
| Decreased appetite | 2 (14.3) | 3 (21.4) | 1 (6.7) | 5 (33.3) |
| Tachycardia | 2 (14.3) | 6 (42.9) | 0 (0) | 2 (13.3) |
| Headache | 0 (0) | 5 (35.7) | 0 (0) | 2 (13.3) |
| Hypoalbuminemia | 3 (21.4) | 4 (28.6) | 1 (6.7) | 3 (20.0) |
| Hypophosphatemia | 3 (21.4) | 4 (28.6) | 2 (13.3) | 3 (20.0) |
| Nausea | 0 (0) | 5 (35.7) | 1 (6.7) | 2 (13.3) |
| Vomiting | 0 (0) | 5 (35.7) | 1 (6.7) | 2 (13.3) |
| Arthralgia | 0 (0) | 0 (0) | 0 (0) | 6 (40.0) |
| Fall | 0 (0) | 4 (28.6) | 0 (0) | 2 (13.3) |
| Hypertension | 0 (0) | 1 (7.1) | 4 (26.7) | 5 (33.3) |
| Hypogammaglobulinemia | 0 (0) | 4 (28.6) | 0 (0) | 2 (13.3) |
| Edema | 1 (7.1) | 3 (21.4) | 0 (0) | 3 (20.0) |
| Pyrexia | 0 (0) | 4 (28.6) | 0 (0) | 2 (13.3) |
| Hematologic‡ | ||||
| Anemia | 5 (35.7) | 5 (35.7) | 5 (33.3) | 6 (40.0) |
| Decreased platelet count | 2 (14.3) | 2 (14.3) | 6 (40.0) | 6 (40.0) |
| Thrombocytopenia | 2 (14.3) | 3 (21.4) | 3 (20.0) | 4 (26.7) |
*
Occurring in >5 patients.
†
Including patients with GI GVHD.
‡
Thrombocytopenia and decreased platelet count were mutually exclusive in this data set. Decreased platelet count was chosen in cases of laboratory decreases; thrombocytopenia was chosen as a clinical diagnosis.