Table 3.
Most frequent AEs (≥20%) by preferred term
| Preferred terms | ATC (n = 36) | BTC (n = 43) | GIST (n = 1) | LGG (n = 13) | HGG (n = 45) | ASI (n = 3) | HCL (n = 55) | MM (n = 10) | Total (n = 206) |
|---|---|---|---|---|---|---|---|---|---|
| Any events | 36 (100.0) | 43 (100.0) | 1 (100.0) | 12 (92.3) | 42 (93.3) | 3 (100.0) | 55 (100.0) | 9 (90.0) | 201 (97.6) |
| Pyrexia | 17 (47.2) | 29 (67.4) | 1 (100.0) | 8 (61.5) | 11 (24.4) | 2 (66.7) | 42 (76.4) | 3 (30.0) | 113 (54.9) |
| Fatigue | 13 (36.1) | 14 (32.6) | 0 | 8 (61.5) | 20 (44.4) | 0 | 29 (52.7) | 3 (30.0) | 87 (42.2) |
| Nausea | 12 (33.3) | 18 (41.9) | 1 (100.0) | 7 (53.8) | 16 (35.6) | 0 | 27 (49.1) | 5 (50.0) | 86 (41.7) |
| Chills | 8 (22.2) | 12 (27.9) | 0 | 3 (23.1) | 5 (11.1) | 1 (33.3) | 31 (56.4) | 2 (20.0) | 62 (30.1) |
| Headache | 8 (22.2) | 10 (23.3) | 0 | 8 (61.5) | 19 (42.2) | 0 | 21 (38.2) | 0 | 66 (32.0) |
| Constipation | 8 (22.2) | 9 (20.9) | 1 (100.0) | 4 (30.8) | 8 (17.8) | 1 (33.3) | 24 (43.6) | 3 (30.0) | 58 (28.2) |
| Vomiting | 7 (19.4) | 15 (34.9) | 1 (100.0) | 4 (30.8) | 13 (28.9) | 1 (33.3) | 14 (25.5) | 3 (30.0) | 58 (28.2) |
| Cough | 4 (11.1) | 10 (23.3) | 0 | 3 (23.1) | 8 (17.8) | 0 | 30 (54.5) | 1 (10.0) | 56 (27.2) |
| Diarrhea | 7 (19.4) | 14 (32.6) | 0 | 4 (30.8) | 5 (11.1) | 1 (33.3) | 19 (34.5) | 4 (40.0) | 54 (26.2) |
| Rash | 10 (27.8) | 12 (27.9) | 0 | 4 (30.8) | 12 (26.7) | 0 | 11 (20.0) | 3 (30.0) | 52 (25.2) |
| Increased AST increased | 5 (13.9) | 11 (25.6) | 0 | 4 (30.8) | 9 (20.0) | 0 | 21 (38.2) | 0 | 50 (24.3) |
| Anemia | 13 (36.1) | 10 (23.3) | 0 | 4 (30.8) | 9 (20.0) | 0 | 10 (18.2) | 3 (30.0) | 49 (23.8) |
| Arthralgia | 5 (13.9) | 6 (14.0) | 0 | 7 (53.8) | 7 (15.6) | 0 | 21 (38.2) | 2 (20.0) | 48 (23.3) |
| Hyperglycemia | 5 (13.9) | 8 (18.6) | 0 | 2 (15.4) | 5 (11.1) | 0 | 26 (47.3) | 0 | 46 (22.3) |
| Edema peripheral | 5 (13.9) | 4 (9.3) | 0 | 2 (15.4) | 3 (6.7) | 1 (33.3) | 27 (49.1) | 2 (20.0) | 44 (21.4) |
| Myalgia | 2 (5.6) | 8 (18.6) | 0 | 2 (15.4) | 7 (15.6) | 0 | 25 (45.5) | 1 (10.0) | 45 (21.8) |
Values are number of patients, n (%).
Preferred terms by MedDRA version 23.0 and CTCAE version 4.0.
All treated patients (primary and expansion cohorts).
AST, aspartate aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities.