Table 3 Incidence of treatment-related adverse events (TRAEs), infusion-related reactions (IRRs), and immune-related adverse events (irAEs)
1 L (n = 62) | 2 L (n = 20) | |||
|---|---|---|---|---|
Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 | |
Any TRAE, n (%)a, b | 51 (82.3) | 8 (12.9) | 14 (70.0) | 1 (5.0) |
Pruritus | 12 (19.4) | 0 | 0 | 0 |
Fatigue | 11 (17.7) | 0 | 5 (25.0) | 1 (5.0) |
Asthenia | 9 (14.5) | 0 | 1 (5.0) | 0 |
Nausea | 9 (14.5) | 0 | 0 | 0 |
Diarrhea | 8 (12.9) | 0 | 3 (15.0) | 0 |
Pyrexia | 8 (12.9) | 0 | 2 (10.0) | 0 |
Decreased appetite | 6 (9.7) | 0 | 2 (10.0) | 0 |
Increased lipase | 6 (9.7) | 4 (6.5) | 1 (5.0) | 0 |
Rash | 6 (9.7) | 1 (1.6) | 0 | 0 |
Pneumonitis | 2 (3.2) | 0 | 2 (10.0) | 0 |
Anaphylactic reaction | 1 (1.6) | 1 (1.6) | 0 | 0 |
Colitis | 1 (1.6) | 1 (1.6) | 0 | 0 |
Thrombocytopenia | 1 (1.6) | 1 (1.6) | 0 | 0 |
Infusion-related reactions, n (%)c, d | 22 (35.5) | 0 | 6 (30.0) | 0 |
Any immune-related AE, n (%)c | 18 (29.0) | 2 (3.2) | 3 (15.0) | 0 |
Hypothyroidism | 7 (11.3) | 0 | 1 (5.0) | 0 |
Rash | 5 (8.1) | 1 (1.6) | 0 | 0 |
Hyperthyroidism | 3 (4.8) | 0 | 0 | 0 |
Pruritus | 3 (4.8) | 0 | 0 | 0 |
Blood TSH increased | 2 (3.2) | 0 | 1 (5.0) | 0 |
Colitis | 1 (1.6) | 1 (1.6) | 0 | 0 |
Diarrhea | 1 (1.6) | 0 | 0 | 0 |
Erythema | 1 (1.6) | 0 | 0 | 0 |
Nephritis | 1 (1.6) | 0 | 0 | 0 |
Pruritus generalized | 1 (1.6) | 0 | 0 | 0 |
Psoriasis | 1 (1.6) | 0 | 0 | 0 |
Rash generalized | 1 (1.6) | 0 | 0 | 0 |
Rash macular | 1 (1.6) | 0 | 0 | 0 |
Pneumonitis | 0 | 0 | 1 (5.0) | 0 |
Rash pruritic | 0 | 0 | 1 (5.0) | 0 |