Table 3.
Term | All grades | Grade 3 | Grade 4 |
---|---|---|---|
n (%) | |||
Patients with at least one adverse event | 65 (92.9) | 13 (18.6) | 2 (2.9) |
Hematologic events | |||
Leukopeniab | 13 (18.6) | 0 | 0 |
Neutropeniac | 10 (14.3) | 1 (1.4) | 0 |
Thrombocytopeniad | 8 (11.4) | 0 | 1 (1.4) |
Anemia | 7 (10) | 0 | 0 |
Nonhematologic events | |||
Pyrexia | 38 (54.3) | 0 | 0 |
Hypothyroidism | 23 (32.9) | 0 | 0 |
Weight gain | 21 (30) | 0 | 0 |
Upper respiratory tract infection | 21 (30) | 2 (2.9) | 0 |
Cough | 12 (17.1) | 0 | 0 |
Pruritus | 12 (17.1) | 0 | 0 |
Rash | 9 (12.9) | 1 (1.4) | 0 |
Alanine aminotransferase increased | 9 (12.9) | 0 | 0 |
Diarrhea | 7 (10) | 0 | 0 |
Aspartate aminotransferase increased | 7 (10) | 0 | 0 |
Hyperuricemia | 6 (8.6) | 0 | 0 |
Weight loss | 6 (8.6) | 0 | 0 |
Asthenia | 5 (7.1) | 0 | 0 |
Blood bilirubin increased | 5 (7.1) | 0 | 0 |
Headache | 5 (7.1) | 0 | 0 |
Hyperlipidemia | 5 (7.1) | 0 | 0 |
Pain in extremity | 5 (7.1) | 0 | 0 |
Chills | 4 (5.7) | 0 | 0 |
Influenza | 4 (5.7) | 0 | 0 |
Lung infection | 4 (5.7) | 0 | 0 |
Nausea | 4 (5.7) | 0 | 0 |
Back pain | 4 (5.7) | 1 (1.4) | 0 |
Viral upper respiratory tract infection | 4 (5.7) | 0 | 0 |
Vomiting | 4 (5.7) | 0 | 0 |
aData are for adverse events reported during treatment in the 70 patients included in the study. Listed events occurred in at least 5% of patients or two or more for grade 3 and any events for grade 4 on or before the data cutoff date of July 23, 2018
bIncludes the MedDRA preferred terms, leukopenia and white blood cell count decreased
cIncludes the MedDRA preferred terms, neutropenia and neutrophil count decreased
dIncludes the MedDRA preferred terms, thrombocytopenia and platelet count decreased.