Preferred term or basket | Any grade n=23 (%) | Grade 3/4 n=23 (%) | |
General | Asthenia | 10 (43.5) | 1 (4.3) |
Weight loss | 5 (21.7) | 0 | |
Gastrointestinal system | Diarrhea | 9 (39.1) | 0 |
Uric acid increased | 9 (39.1) | 0 | |
Elevated hepatic enzymes* | 10 (43.5) | 0 | |
Abdominal pain | 6 (26.1) | 0 | |
Decreased appetite | 6 (26.1) | 0 | |
Bile acids increased | 4 (17.4) | 0 | |
Musculoskeletal system | Pain and arthralgia | 10 (43.5) | 0 |
Hematologic system | Leukopenia | 3 (13.0) | 0 |
Neutropenia | 4 (17.4) | 1 (4.3) | |
Endocrine/metabolism | Hypothyroidism† | 16 (69.6) | 0 |
Lipase increased | 12 (52.2) | 0 | |
Hyperthyroidism | 7 (30.4) | 0 | |
Hyperglycemia | 5 (21.7) | 0 | |
Renal system | Proteinuria | 6 (26.1) | 1 (4.3) |
Creatinine increased | 5 (21.7) | 1 (4.3) | |
Cardiovascular system | Hypertension | 9 (39.1) | 1 (4.3) |
ST-T changes | 5 (21.7) | 0 | |
Myocarditis‡ | 1 (4.3) | 1 (4.3) | |
Prolonged ECG QT | 1 (4.3) | 1 (4.3) | |
Dermatologic system | PPE/rash | 16 (69.6) | 6 (26.1) |
Ulcer§ | 8 (34.8) | 0 | |
Others | Dysphonia | 10 (43.5) | 0 |
Serum albumin decreased | 9 (39.1) | 0 | |
Hemorrhage¶ | 6 (26.1) | 0 | |
Infections | 6 (26.1) | 0 | |
Abscess | 2 (8.7) | 1 (4.3) | |
Peritonitis‡ | 1 (4.3) | 1 (4.3) |
*Elevated hepatic enzymes included aspartate aminotransferase increased, alanine transaminase increased, and γ-glutamyl transpeptidase increased.
†Hypothyroidism basket included hypothyroidism and increased blood thyroid-stimulating hormone.
‡Clinically confirmed immunotherapy-related adverse events.
§Including oral and virginal ulcers.
¶Hemorrhage basket included gingival bleeding, vaginal hemorrhage, and hemoptysis.
PPE, palmar-plantar erythrodysethesia syndrome.