Table 3.
Treatment-related AEs occurring in ≥5.0% of the total study population and immune-mediated AEs and infusion-related reactions occurring in ≥1 patient
| AEs | ||||
|---|---|---|---|---|
| Grade 1 or 2 | Grade 3 | Grade 4 | Any grade | |
| Treatment-related AEs, n (%)* | ||||
| Any AE | 128 (60.9) | 23 (11.0) | 2 (1.0) | 153 (72.9) |
| Hypothyroidism | 30 (14.3) | 0 (0) | 0 (0) | 30 (14.3) |
| Pyrexia | 23 (10.9) | 1 (0.5) | 0 (0) | 24 (11.4) |
| Rash | 23 (11.0) | 0 (0) | 0 (0) | 23 (11.0) |
| Fatigue | 22 (10.5) | 1 (0.5) | 0 (0) | 23 (11.0) |
| Headache | 16 (7.6) | 0 (0) | 0 (0) | 16 (7.6) |
| Diarrhea | 15 (7.1) | 3 (1.4) | 0 (0) | 18 (8.6) |
| Nausea | 15 (7.1) | 0 (0) | 0 (0) | 15 (7.1) |
| Cough | 13 (6.2) | 1 (0.5) | 0 (0) | 14 (6.7) |
| Pruritus | 13 (6.2) | 0 (0) | 0 (0) | 13 (6.2) |
| Arthralgia | 11 (5.2) | 1 (0.5) | 0 (0) | 12 (5.7) |
| Infusion-related reaction | 11 (5.2) | 0 (0) | 0 (0) | 11 (5.2) |
| Neutropenia | 6 (2.9) | 5 (2.4) | 0 (0) | 11 (5.2) |
| Immune-mediated AEs and infusion-related reactions, n (%)† | ||||
| Any AE | 65 (31.0) | 5 (2.4) | 1 (0.5) | 71 (33.8) |
| Hypothyroidism | 33 (15.7) | 0 | 0 | 33 (15.7) |
| Infusion-related reactions | 11 (5.2) | 0 | 0 | 11 (5.2) |
| Pneumonitis | 10 (4.8) | 0 | 0 | 10 (4.8) |
| Hyperthyroidism | 8 (3.8) | 0 | 0 | 8 (3.8) |
| Cytokine release syndrome | 5 (2.4) | 1 (0.5) | 0 | 6 (2.9) |
| Hypersensitivity | 5 (2.4) | 1 (0.5) | 0 | 6 (2.9) |
| Colitis | 1 (0.5) | 1 (0.5) | 0 | 2 (1.0) |
| Myositis | 1 (0.5) | 1 (0.5) | 0 | 2 (1.0) |
| Myocarditis | 0 | 0 | 1 (0.5) | 1 (0.5) |
| Autoimmune thyroiditis | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Iridocyclitis | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Iritis | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Enterocolitis | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Autoimmune hepatitis | 0 | 1 (0.5) | 0 | 1 (0.5) |
| Drug hypersensitivity | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Sarcoidosis | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Encephalitis | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Organizing pneumonia | 1 (0.5) | 0 | 0 | 1 (0.5) |
| Pruritus | 0 | 1 (0.5) | 0 | 1 (0.5) |
N = 210.
*
No grade 5 AEs occurred.
†
Immune-mediated AEs were based on a list of terms specified by the sponsor and included by the investigator, regardless of attribution to study treatment or immune relatedness.