| Urelumab | Urelumab | Urelumab | |
|---|---|---|---|
| 0.1 mg/kg | 0.3 mg/kg | ≥1 mg/kg | |
| Event | (n = 61)c | (n = 56)c | (n = 229)c |
| Any grade ≤4 AEsa, % (grade 3–4, %)d | |||
| AST increased | 8.2 | 14.3 (3.6) | 27.1 (13.5) |
| ALT increased | 6.6 (1.6) | 10.7 (3.6) | 26.6 (16.6) |
| Fatigue | 16.4 | 14.3 | 24.0 |
| Rash | 4.9 | 7.1 | 19.7 |
| Nausea | 13.1 | 3.6 | 13.5 |
| Pruritus | 4.9 | 5.4 | 13.1 |
| Decreased appetite | 8.2 | 3.6 | 12.2 |
| Pyrexia | 4.9 | 1.8 | 12.2 |
| Diarrhea | 3.3 | 3.6 | 12.2 |
| Asthenia | 8.2 | 0 | 7.9 |
| Headache | 1.6 | 1.8 | 7.0 |
| Neutropenia | 4.9 (3.3) | 0 | 6.1 (2.6) |
| Vomiting | 3.3 | 0 | 5.2 |
| Any grade ≤4 SAEsa, % (grade 3–4, %)d | |||
| ALT increased | 1.6 | 3.6 (3.6) | 5.2 (5.2) |
| AST increased | 3.6 (3.6) | 4.8 (4.4) | |
| Neutropenia | 3.1 (3.1) | ||
| Thrombocytopenia | 2.2 (1.3) | ||
| Febrile neutropenia | 1.6 (1.6)e | 1.7 (1.7) | |
| Cellulitis | 1.3 (0.9) | ||
| Anemia | 0.9 (0.4) | ||
| Leukopenia | 0.9 (0.9) | ||
| Fatigue | 0.9 (0.4) | ||
| Nausea | 0.4 (0.4) | ||
| Decreased appetite | 0.4 (0.4) | ||
| Pyrexia | 0.4 (0.4) | ||
| Increased blood bilirubin | 0.4 (0.4) | ||
| Abnormal LFT | 1.8 (1.8) | 0.4 (0.4) | |
| Abdominal pain | 0.4 (0.4) | ||
| Hepatic failure | 0.4 (0.4) | ||
| Hyperbilirubinemia | 0.4 (0.4) | ||
| Anaphylactic shock | 0.4 (0.4) | ||
| Decreased neutrophil count | 0.4 (0.4) | ||
| Acute hepatitis | 1.8 (1.8) | ||
| Erysipelas | 1.6 | ||
| Enteritis | 1.8 | ||
| Grade 5 SAEsa | |||
| Malignant neoplasm progression | 0.4 | ||
| Autoimmune hepatitis | 0.4 | ||
↵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.