Table 2.
Patients with treatment‐related adverse events
| All treated patients, n (%) N = 38 | ||
|---|---|---|
| Any grade | Grades 3‐5 | |
| Treatment‐related AE | 33 (87) | 11 (29) |
| Treatment‐related AE occurring in >10% of patients | ||
| Malaise | 8 (21) | 0 (0) |
| Diarrhea | 6 (16) | 1 (3) |
| Rash maculopapular | 6 (16) | 0 (0) |
| Aspartate aminotransferase increased | 5 (13) | 1 (3) |
| Decreased appetite | 5 (13) | 1 (3) |
| Alanine aminotransferase increased | 5 (13) | 1 (3) |
| Pruritus | 5 (13) | 0 (0) |
| Rash | 5 (13) | 0 (0) |
| Nausea | 4 (11) | 0 (0) |
| Fatigue | 4 (11) | 0 (0) |
| Arthralgia | 4 (11) | 0 (0) |
| Immune‐mediated AE and infusion reactions, n (%)a | 9 (24) | 1 (3) |
| Colitis | 1 (3) | 0 (0) |
| Hyperthyroidism | 1 (3) | 0 (0) |
| Hypothyroidism | 2 (5) | 0 (0) |
| Infusion reactions | 1 (3) | 0 (0) |
| Myositis | 1 (3) | 0 (0) |
| Pneumonitis | 4 (11) | 1 (3) |
| Uveitis | 1 (3) | 0 (0) |
AE, adverse event.
a
Regardless of attribution to study treatment or immune‐relatedness by the investigator.