Table 3.

Adverse events tremelimumab monotherapy (SAS).

Overall AE
na (%)
Any AE30 (93.8)
 AE grade 3/419 (59.4)
 Any SAE18 (56.3)
 Any AE leading to discontinuation of tremelimumab10 (31.3)
 Any AE leading to death0
TRAEsb18 (56.3)
 TRAE grade 3/49 (28.1)
 TRAE SAE9 (28.1)
 TRAE leading to discontinuation of tremelimumab9 (28.1)
 TRAE leading to death0
imAEs11 (34.4)
 imAE grade 3/45 (15.6)
 imSAE6 (18.8)
 imAE leading to discontinuation of tremelimumab5 (15.6)
 imAE leading to death0
Most common (n = ≥2; ≥5% patients) TRAEs reported
 Fatigue9 (28.1)
 Colitisc8 (25.1)
 Pruritis7 (21.9)
 Diarrhea6 (18.8)
 Nausea6 (18.8)
 Dry skin4 (12.5)
 Decreased appetite3 (9.4)
 Headache3 (9.4)
 Hypothyroidism3 (9.4)
 Lipase increased3 (9.4)
 Vomiting3 (9.4)
 Amylase increased2 (6.3)
 Anemia2 (6.3)
 Hypokalemia2 (6.3)
 Muscular weakness2 (6.3)
 Pruritis generalized2 (6.3)
 Pyrexia2 (6.3)
 Rash2 (6.3)
 Rash maculopapular2 (6.3)
  • Abbreviations: AE, adverse event; imAE, immune-mediated adverse event; imSAE, immune-mediated serious adverse event; SAE, serious adverse event; SAS, safety analyses set; TRAE, treatment-related adverse event.

  • aPatients with multiple events in the same category are counted only once in that category.

  • bAs assessed by the investigator.

  • cColitis and autoimmune colitis combined.