Table 2

Characteristics of the immune-related adverse events

irAEs (n*)Initial irAE(s)†
(n=191)
Second irAEs after ICI rechallenge‡
(n=77)
Initial irAEs (%)GradeSystemic
corticosteroids
Second irAEs (%)GradeSystemic
corticosteroids
23/423/4
Gastrointestinal disorders (71) 24.6 17 30 35§ 31.2 15 9 20
 Colitis (57)19.413243026.012817
 Pancreatic disorders (13)4.73655.2313
 Gastritis (1)0.51 – – – – – –
Endocrine disorders (41) 17.8 23 11 4 9.1 4 3 1
 Hyperthyroidism (13)6.310241.31 –1
 Hypophysitis (10)4.754 –1.31 – –
 Diabetes (8)2.122 –5.213 –
 Hypothyroidism (5)2.641 –1.3 – – –
 Adrenal insufficiency (5)2.122 –1.31 – –
Hepatitis (39) 16.2 12 19 17§ 10.4 2 6 7
Respiratory disorders (28) 11.0 15 6 15 9.1 5 2 4
 Pneumonitis (24)9.4126157.8424
 Pulmonary sarcoidosis (2)1.02 – – – – – –
 Pulmonary embolism (2)0.51 – –1.31 – –
Skin disorders (28) 9.4 9 9 8§ 13.0 6 4 6
Musculoskeletal disorders (17) 5.8 8 3 11§ 7.8 5 1 3
 Arthritis/arthralgia (14)4.76396.55 –2
 Myositis (3)1.02 –21.3 –11
Renal and urinary disorders (16) 5.2 6 4 5 7.8 6  – 6
Neurological disorders (8) 3.1 4 2 5 2.6 1 1 1
Hematological disorders (8) 3.1 2 4 4 2.6 2  – –
Ocular disorders (7) 2.6 3 2 1 2.6 2  – 2
Cardiac disorders (5) 1.0  – 2  – 3.9 2 1 2
Total (268) 100.0 99 92 105** 100.0 50 27 52††
  • Detailed data on recurrent irAEs are shown in online supplemental table.

  • The bold values refer to organ involvement. Non bold values refer to more precise diseases.

  • *Including initial and second irAEs.

  • †191 grade ≥2 irAEs led to discontinuation in 180 patients.

  • ‡77 recurrent and/or new onset irAEs occurred in 70 patients.

  • §Immunosuppressive drugs were required in 11 initial irAEs (nine patients): colitis (n=5), hepatitis (n=3), arthritis (n=2) and lichenoid dermatitis (n=1).

  • ¶Immunosuppressive drugs were required in 6 second irAEs (six patients): colitis (n=5) and arthritis (n=1).

  • **Missing data in four initial irAEs.

  • ††Missing data in 13 second irAEs.

  • ICI, immune checkpoint inhibitor; IrAE, immune-related adverse event.