Nonlaboratory AEs and treatment-emergent laboratory abnormalities of interest occurring in patients receiving PI3Kδ inhibitor INCB040093 alone or in combination with JAK1 inhibitor itacitinib (safety population)
| Event or abnormality . | Monotherapy (n = 49) . | Combination therapy (n = 72) . | ||
|---|---|---|---|---|
| All grades, n (%) . | Grade ≥3, n (%) . | All grades, n (%) . | Grade ≥3, n (%) . | |
| Nonlaboratory AEs (MedDRA preferred term)* | ||||
| Diarrhea | 19 (39) | 2 (4) | 22 (31) | 1 (1) |
| Fatigue | 17 (35) | 0 | 28 (39) | 1 (1) |
| Cough | 16 (33) | 0 | 31 (43) | 0 |
| Nausea | 16 (33) | 0 | 33 (46) | 2 (3) |
| Headache | 15 (31) | 0 | 14 (19) | 0 |
| Back pain | 14 (29) | 1 (2) | 16 (22) | 1 (1) |
| Decreased appetite | 13 (27) | 0 | 19 (26) | 0 |
| Dyspnea | 13 (27) | 2 (4) | 13 (18) | 0 |
| Pyrexia | 13 (27) | 2 (4) | 26 (36) | 1 (1) |
| Vomiting | 13 (27) | 1 (2) | 25 (35) | 2 (3) |
| Upper respiratory tract infection | 12 (24) | 0 | 14 (19) | 0 |
| Constipation | 11 (22) | 0 | 16 (22) | 1 (1) |
| Chills | 7 (14) | 0 | 23 (32) | 0 |
| Night sweats | 8 (16) | 0 | 19 (26) | 0 |
| Hematologic laboratory abnormalities | ||||
| Neutropenia | 22 (45) | 9 (18) | 35 (49) | 17 (24) |
| Anemia | 15 (31) | 5 (10) | 36 (50) | 7 (10) |
| Thrombocytopenia | 15 (31) | 3 (6) | 50 (69) | 8 (11) |
| Chemical laboratory abnormalities | ||||
| ALT increased | 23 (47) | 10 (20) | 30 (42) | 2 (3) |
| AST increased | 21 (43) | 9 (18) | 41 (57) | 2 (3) |
| Event or abnormality . | Monotherapy (n = 49) . | Combination therapy (n = 72) . | ||
|---|---|---|---|---|
| All grades, n (%) . | Grade ≥3, n (%) . | All grades, n (%) . | Grade ≥3, n (%) . | |
| Nonlaboratory AEs (MedDRA preferred term)* | ||||
| Diarrhea | 19 (39) | 2 (4) | 22 (31) | 1 (1) |
| Fatigue | 17 (35) | 0 | 28 (39) | 1 (1) |
| Cough | 16 (33) | 0 | 31 (43) | 0 |
| Nausea | 16 (33) | 0 | 33 (46) | 2 (3) |
| Headache | 15 (31) | 0 | 14 (19) | 0 |
| Back pain | 14 (29) | 1 (2) | 16 (22) | 1 (1) |
| Decreased appetite | 13 (27) | 0 | 19 (26) | 0 |
| Dyspnea | 13 (27) | 2 (4) | 13 (18) | 0 |
| Pyrexia | 13 (27) | 2 (4) | 26 (36) | 1 (1) |
| Vomiting | 13 (27) | 1 (2) | 25 (35) | 2 (3) |
| Upper respiratory tract infection | 12 (24) | 0 | 14 (19) | 0 |
| Constipation | 11 (22) | 0 | 16 (22) | 1 (1) |
| Chills | 7 (14) | 0 | 23 (32) | 0 |
| Night sweats | 8 (16) | 0 | 19 (26) | 0 |
| Hematologic laboratory abnormalities | ||||
| Neutropenia | 22 (45) | 9 (18) | 35 (49) | 17 (24) |
| Anemia | 15 (31) | 5 (10) | 36 (50) | 7 (10) |
| Thrombocytopenia | 15 (31) | 3 (6) | 50 (69) | 8 (11) |
| Chemical laboratory abnormalities | ||||
| ALT increased | 23 (47) | 10 (20) | 30 (42) | 2 (3) |
| AST increased | 21 (43) | 9 (18) | 41 (57) | 2 (3) |
Nonlaboratory AEs and laboratory abnormalities are discussed separately.
MedDRA, Medical Dictionary for Regulatory Activities.
Nonlaboratory AEs occurring in ≥20% of patients in any treatment group.