Table 2.
Adverse Events
| Arm 1 N=15 | Arm 2 N=15 | Total N=30 | ||||
|---|---|---|---|---|---|---|
| Immune Related Adverse Events | Grade 1/2 | Grade 3/4 | Grade 1/2 | Grade 3/4 | Grade 1/2 | Grade 3/4 |
| Dermatological | ||||||
| Localized | 0 | 0 | 15 | 0 | 15 | 0 |
| Systemic* | 9 | 0 | 11 | 1 | 20 | 1 |
| Endocrine | ||||||
| Adrenal insufficiency | 0 | 0 | 1 | 0 | 1 | 0 |
| Hypophysitis | 2 | 0 | 1 | 0 | 3 | 0 |
| HEENT | ||||||
| Conjunctivitis | 1 | 0 | 0 | 0 | 1 | 0 |
| Gastrointestinal | ||||||
| Colitis | 2 | 1 | 3 | 1 | 5 | 2 |
| Neurological | ||||||
| Guillain-Barre Syndrome | 0 | 1 | 0 | 0 | 0 | 1 |
| Pulmonary | ||||||
| Pneumonitis | 0 | 0 | 0 | 1 | 0 | 1 |
| Renal | ||||||
| Nephritis | 0 | 1 | 0 | 0 | 0 | 1 |
| Other Related Adverse Events | ||||||
| Constitutional | ||||||
| Arthralgias | 0 | 0 | 1 | 0 | 1 | 0 |
| Anorexia | 0 | 0 | 2 | 0 | 2 | 0 |
| Cramps | 1 | 0 | 0 | 0 | 1 | 0 |
| Diarrhea | 0 | 0 | 2 | 0 | 2 | 0 |
| Dry eye | 1 | 0 | 0 | 0 | 1 | 0 |
| Dry skin | 1 | 0 | 0 | 0 | 1 | 0 |
| Fatigue | 0 | 0 | 6 | 0 | 6 | 0 |
| Fever | 3 | 0 | 5 | 0 | 8 | 0 |
| Flu-like symptoms | 2 | 0 | 4 | 0 | 6 | 0 |
| Headache | 0 | 0 | 3 | 0 | 3 | 0 |
| Nausea | 1 | 0 | 2 | 0 | 3 | 0 |
*
While there was only one grade 3 rash observed in arm 2, rashes were more severe/symptomatic than in arm 1.