Table 3.
Severe AEs
| Severe AE | Grade 3 or 4, n (%) | Phase |
|---|---|---|
| Pneumonia | 4 (11) | Induction and maintenance |
| Neutropenic fever | 3 (8) | Induction and maintenance |
| Tumor flare | 4 (11) | Induction |
| Abdominal pain | 2 (5) | Induction |
| Serum sickness | 2 (5) | Induction |
| Syncope | 2 (5) | Maintenance |
| Cholecystitis | 2 (5) | Maintenance |
| UTI | 2 (5) | Maintenance |
| Atrial fibrillation | 1 (3) | Induction |
| Cholangitis | 1 (3) | Induction |
| Dyspnea | 1 (3) | Induction |
| Vertigo | 1 (3) | Induction |
| Ventricular fibrillation | 1 (3) | Induction |
| Rash | 1 (3) | Induction |
| Infusion reaction | 1 (3) | Induction |
| Escherichia coli urosepsis | 1 (3) | Maintenance |
| Hand cellulitis | 1 (3) | Maintenance |
| West Nile viral encephalitis | 1 (3) | Maintenance |
| Car accident | 1 (3) | Maintenance |
| Left femoral neck fracture | 1 (3) | Maintenance |
| SPMs* | ||
| Nonmelanoma skin cancers | 3 (8) | Induction and maintenance |
| Melanoma in situ | 2 (5) | Induction and maintenance |
| Merkel cell carcinoma | 1 (3) | Maintenance |
| Pancreatic cancer | 1 (3) | Maintenance |
Severe AEs are listed, regardless of attribution.
*
SPMs were reported in 6 subjects, including 2 patients with invasive SPMs. One subject had both Merkel cell carcinoma and melanoma in situ.