Table 3

Treatment-related adverse events (AEs) of any grade reported >10% and grade 3/4 AEs in all patients

Preferred term or basketAny grade
n=23 (%)
Grade 3/4
n=23 (%)
GeneralAsthenia10 (43.5)1 (4.3)
Weight loss5 (21.7)0
Gastrointestinal systemDiarrhea9 (39.1)0
Uric acid increased9 (39.1)0
Elevated hepatic enzymes*10 (43.5)0
Abdominal pain6 (26.1)0
Decreased appetite6 (26.1)0
Bile acids increased4 (17.4)0
Musculoskeletal systemPain and arthralgia10 (43.5)0
Hematologic systemLeukopenia3 (13.0)0
Neutropenia4 (17.4)1 (4.3)
Endocrine/metabolismHypothyroidism†16 (69.6)0
Lipase increased12 (52.2)0
Hyperthyroidism7 (30.4)0
Hyperglycemia5 (21.7)0
Renal systemProteinuria6 (26.1)1 (4.3)
Creatinine increased5 (21.7)1 (4.3)
Cardiovascular systemHypertension9 (39.1)1 (4.3)
ST-T changes5 (21.7)0
Myocarditis‡1 (4.3)1 (4.3)
Prolonged ECG QT1 (4.3)1 (4.3)
Dermatologic systemPPE/rash16 (69.6)6 (26.1)
Ulcer§8 (34.8)0
OthersDysphonia10 (43.5)0
Serum albumin decreased9 (39.1)0
Hemorrhage¶6 (26.1)0
Infections6 (26.1)0
Abscess2 (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.