Table 2.

Investigator-reported treatment-related AEsa and SAEsb

UrelumabUrelumabUrelumab
0.1 mg/kg0.3 mg/kg≥1 mg/kg
Event(n = 61)c(n = 56)c(n = 229)c
Any grade ≤4 AEsa, % (grade 3–4, %)d
 AST increased8.214.3 (3.6)27.1 (13.5)
 ALT increased6.6 (1.6)10.7 (3.6)26.6 (16.6)
 Fatigue16.414.324.0
 Rash4.97.119.7
 Nausea13.13.613.5
 Pruritus4.95.413.1
 Decreased appetite8.23.612.2
 Pyrexia4.91.812.2
 Diarrhea3.33.612.2
 Asthenia8.207.9
 Headache1.61.87.0
 Neutropenia4.9 (3.3)06.1 (2.6)
 Vomiting3.305.2
Any grade ≤4 SAEsa, % (grade 3–4, %)d
 ALT increased1.63.6 (3.6)5.2 (5.2)
 AST increased3.6 (3.6)4.8 (4.4)
 Neutropenia3.1 (3.1)
 Thrombocytopenia2.2 (1.3)
 Febrile neutropenia1.6 (1.6)e1.7 (1.7)
 Cellulitis1.3 (0.9)
 Anemia0.9 (0.4)
 Leukopenia0.9 (0.9)
 Fatigue0.9 (0.4)
 Nausea0.4 (0.4)
 Decreased appetite0.4 (0.4)
 Pyrexia0.4 (0.4)
 Increased blood bilirubin0.4 (0.4)
 Abnormal LFT1.8 (1.8)0.4 (0.4)
 Abdominal pain0.4 (0.4)
 Hepatic failure0.4 (0.4)
 Hyperbilirubinemia0.4 (0.4)
 Anaphylactic shock0.4 (0.4)
 Decreased neutrophil count0.4 (0.4)
 Acute hepatitis1.8 (1.8)
 Erysipelas1.6
 Enteritis1.8
Grade 5 SAEsa
 Malignant neoplasm progression0.4
 Autoimmune hepatitis0.4
  • aData shown are for treatment-related AEs occurring in ≥5% patients in any dose group; all grade 3, 4, and 5 SAEs and grade 1 or 2 SAEs reported more than once are shown. Please note that the classification of AEs as either treatment-related or serious (both of which are presented in this table) is different, per the criteria defined in the protocols.

  • bData are from the 346 patients who received at least one dose of urelumab.

  • cPatients received urelumab every 3 weeks, except 40 patients from study -006 who received 1 mg/kg every 6 weeks.

  • dAbsence of parentheses indicates no grade 3–4 AEs or SAEs were reported.

  • eFebrile neutropenia was deemed to be unrelated to urelumab after the data cut-off date for this report.