Table 4. Non-immune adverse events and immune adverse events in the as-treated population.
| Event, n (%) | Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Lead to discontinuation | Lead to temporary suspension |
|---|---|---|---|---|---|---|---|
| Non-immune adverse events | |||||||
| Nausea | 65 (53.7) | 37 (30.6) | 37 (30.6) | 37 (30.6) | – | 1 (0.8) | 1 (0.8) |
| Vomiting | 24 (19.8) | 11 (9.1) | 11 (9.1) | 2 (1.7) | – | 1 (0.8) | – |
| Diarrhea | 14 (11.6) | 9 (7.4) | 3 (2.5) | 2 (1.7) | – | – | 3 (2.5) |
| Decreased appetite | 45 (37.2) | 16 (13.2) | 25 (20.7) | 4 (3.3) | – | – | 1 (0.8) |
| Constipation | 17 (14.0) | 12 (9.9) | 4 (3.3) | 1 (0.8) | – | – | 1 (0.8) |
| Cytolysis | 40 (33.0) | 21 (17.4) | 11 (9.1) | 8 (6.6) | – | 2 (1.7) | 10 (8.3) |
| Cough | 8 (6.6) | 8 (6.6) | – | – | – | – | – |
| Dyspnea | 17 (14.0) | 2 (1.7) | 7 (5.8) | 7 (5.8) | 1 (0.8) | 6 (5.0) | 8 (6.6) |
| Skin reactions | 26 (21.5) | 13 (10.7) | 12 (9.9) | 1 (0.8) | – | 11 (9.0) | 2 (1.7) |
| Kidney toxicity | 22 (18.1) | 7 (5.8) | 10 (8.3) | 5 (4.1) | – | 9 (7.4) | 6 (5.0) |
| Asthenia | 92 (76.0) | 44 (36.4) | 39 (32.2) | 9 (7.4) | – | 6 (5.0) | 3 (2.5) |
| Anemia | 74 (61.2) | 43 (35.5) | 20 (16.5) | 10 (8.3) | 1 (0.8) | 4 (3.3) | 3 (2.5) |
| Thrombocytopenia | 19 (15.8) | 5 (4.1) | 7 (5.8) | 3 (2.5) | 4 (3.3) | 2 (1.7) | 6 (5.0) |
| Neutropenia | 41 (33.9) | 6 (5.0) | 8 (6.6) | 10 (8.3) | 17 (14.0) | 6 (5.0) | 10 (8.3) |
| Neuropathy | 11 (9.1) | 9 (7.4) | 1 (0.8) | 1 (0.8) | – | 1 (0.8) | 1 (0.8) |
| Stomatitis | 14 (11.6) | 10 (8.3) | 4 (3.3) | – | – | – | – |
| Lacrimation increased | 30 (24.8) | 15 (12.4) | 15 (12.4) | – | – | – | – |
| Pneumonitis | 7 (5.8) | – | 5 (4.1) | 2 (1.7) | – | 6 (7.4) | 1 (0.8) |
| Arthralgia | 6 (5.0) | 4 (3.3) | 1 (0.8) | 1 (0.8) | – | 1 (0.8) | – |
| Peripheral edema | 17 (14.0) | 12 (9.9) | 4 (3.3) | 1 (0.8) | – | 7 (5.8) | 2 (1.7) |
| Immune adverse events | |||||||
| Diarrhea | 2 (1.7) | – | – | 2 (1.7) | – | 2 (1.7) | – |
| Cytolysis | 2 (1.7) | – | – | 2 (1.7) | – | 2 (1.7) | – |
| Dyspnea | 1 (0.8) | – | – | 1 (0.8) | – | 1 (0.8) | – |
| Skin reactions | 4 (3.3) | 1 (0.8) | 1 (0.8) | 1 (0.8) | 1 (0.8) | 2 (1.7) | – |
| Kidney toxicity | 1 (0.8) | – | – | 1 (0.8) | – | 1 (0.8) | – |
| Thyroidism | 24 (19.8) | 11 (9.1) | 10 (8.3) | 3 (2.5) | – | – | 1 (0.8) |
| Pneumonitis | 4 (3.3) | – | 1 (0.8) | 1 (0.8) | 2 (1.7) | 4 (3.3) | – |
| Colitis | 2 (1.7) | – | – | 1 (0.8) | 1 (0.8) | – | 2 (1.7) |
| Arthralgia | 3 (2.5) | – | 2(1.7) | 1 (0.8) | – | 2 (1.7) | – |
| Adrenal insufficiency | 1 (0.8) | – | – | 1 (0.8) | – | 1 (0.8) | – |
| Encephalitis | 1 (0.8) | – | 1 (0.8) | – | – | – | 1 (0.8) |