Table 2.
Adverse Events ≥ Grade 2, Possibly, Probably, or Definitely Related
| Grade 2 | Grade 3 | Grade 4 | Total | |
|---|---|---|---|---|
| Endocrine | ||||
| Endocrine disorders—other | 1 | 1 | ||
| Hypothyroidism | 1 | 1 | ||
| Ophthalmic | ||||
| Optic nerve disorder | 1 | 1 | ||
| Uveitis | 1 | 1 | ||
| Gastrointestinal | ||||
| Diarrhea | 1 | 1 | ||
| Duodenal ulcer | 1a | 1 | ||
| Nausea | 1 | 1 | ||
| Pancreatitis | 1a | 1 | ||
| Vomiting | 1 | 1 | ||
| Constitutional and infusion reactions | ||||
| Fatigue | 6 | 1 | 7 | |
| Infusion-related reaction | 1 | 1 | ||
| Laboratory | ||||
| Lipase increased | 1 | 2 | 1a | 4 |
| Serum amylase increased | 1 | 1a | 2 | |
| Metabolism and nutrition | ||||
| Hyperglycemia | 2 | 2 | ||
| Nervous system | ||||
| Edema cerebral | 1 | 1 | ||
| Encephalopathy | 1 | 1 | ||
| Headache | 2 | 1 | 3 | |
| Respiratory | ||||
| Pneumonitis | 1 | 1a | 2 | |
| Total | 22 | 7 | 3 | 32 |
aOccurred during 30 days’ follow-up after study therapy discontinuation.