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 |
a The incidence of treatment-related infusion-related reactions based on the single MedDRA preferred term is not listed
b Any grade TRAEs in ≥ 10% patents and all grade 3 TRAEs
c Composite term; includes AEs categorized as infusion-related reaction, drug hypersensitivity, or hypersensitivity reaction that occurred on the day of infusion or day after infusion, in addition to signs/symptoms of infusion-related reaction (based on a prespecified list of MedDRA preferred terms) that occurred on the same day of infusion and resolved within 2 days
d Includes AEs classified by investigators as related or unrelated to treatment
1 L first-line subgroup, 2 L second-line subgroup, AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, TRAE treatment-related adverse events, TSH thyroid-stimulating hormone