Table 2.
Summary of Adverse Events
| Any grade | Grades 1–2 | Grade 3 | |
|---|---|---|---|
| Any adverse event | 135 | 120 | 15 |
| Any treatment-related adverse event | 31 | 28 | 3 |
| Specific treatment-related adverse event (immune) | |||
| Anaphylaxis (with hypotension and angioedema) | 1 | 0 | 1 |
| Arthralgia (flare of rheumatoid arthritis) | 1 | 1 | 0 |
| Colitis* | 2 | 1 | 1 |
| Pruritus | 7 | 7 | 0 |
| Rash | 4 | 4 | 0 |
| Uveitis | 1 | 1 | 0 |
| Specific treatment-related adverse event (nonimmune) | |||
| Abdominal Pain | 1 | 1 | 0 |
| Anorexia | 2 | 2 | 0 |
| Chills | 1 | 1 | 0 |
| Dermatitis (radiation) | 1 | 1 | 0 |
| Diaphoresis | 1 | 1 | 0 |
| Diarrhea* | 1 | 1 | 0 |
| Fatigue | 3 | 2 | 1 |
| Headache | 1 | 1 | 0 |
| Nausea | 4 | 4 | 0 |
| Non-treatment related adverse events | 104 | 92 | 12 |
There were no grade 4 toxicities.
* Diarrhea was defined as a disorder characterized by frequent and watery bowel movements; colitis was defined as a disorder characterized by inflammation of the colon.