Table 2

Treatment-related adverse events (TRAEs) by type

TRAEsSitravatinib and nivolumab-relatedSitravatinib-relatedNivolumab-related
Grade 1–2 n (%)Grade 3–4Grade 1–2Grade 3Grade 1–2Grade 3
N (%)N (%)N (%)N (%)N (%)
Total number of events11 (100)39 (100)9 (100)
Total number of events by grade9 (81)2 (19)38 (97)1 (3)9 (100)0
Fatigue3 (27)3 (8)2 (23)
Gastrointestinal disorders10 (26)
  • Nausea/vomiting

2 (5)1 (11)
  • Diarrhea

4 (11)
  • Anorexia

3 (27)2 (5)
  • Other

2 (5)1 (11)
Arthralgias/myalgias1 (3)1 (11)
Skin disorders
  • Rash, dryness, pruritus

1 (9)2 (5)2 (22)
  • Palmar–plantar erythrodysesthesia

1 (3)
Dysphonia6 (16)1 (11)
Mucositis3 (8)1 (11)
Hypertension4 (11)1 (3)
Laboratory toxicity
  • ALT/AST increase

1 (9)5 (13)
  • Thrombocytopenia

2 (5)
  • Proteinuria

1 (3)
  • Lipase increase

1 (9)
Other
  • Wound infection

1 (9)
  • Tracheostomy bleeding

1 (9)
  • In this table, the denominators are based on the total number of TRAEs observed for each of three categories: sitravatinib–nivolumab related; sitravatinib-related; and nivolumab-related.

  • ALT, alanine transaminase; AST, asparte transaminase (AST).