Table 2.
Treatment-related adverse events.
| All patients (n = 59) |
||
|---|---|---|
| Any Grade | Grade ≥3 | |
| All AEs | 46 (78%) | 12 (20%) |
| Fatigue | 22 (37%) | 3 (5%) |
| Pruritus | 3 (5%) | 0 (0%) |
| Fever | 4 (7%) | 0 (0%) |
| Nausea | 11 (19%) | 2 (3%) |
| Vomiting | 5 (8%) | 1 (2%) |
| Anorexia | 5 (8%) | 0 (0%) |
| Transaminitis | 10 (17%) | 2 (3%) |
| Colitis | 2 (3%) | 1 (2%) |
| Diarrhea | 4 (7%) | 0 (0%) |
| Rash/dermatitis | 10 (17%) | 0 (0%) |
| Cough/SOB | 4 (7%) | 0 (0%) |
| Pneumonitisa | 6 (10%) | 3 (5%) |
| Hypo/hyper-thyroidism | 5 (8%) | 0 (0%) |
| Hypophysitis | 3 (5%) | 0 (0%) |
| AKI | 5 (8%) | 1 (2%) |
| Electrolytes | 5 (8%) | 2 (3%) |
| Extremity edema | 8 (13%) | 0 (0%) |
| Pancytopenia | 1 (2%) | 1 (2%) |
| Anemia | 8 (13%) | 1 (2%) |
| Hyperglycemia | 1 (2%) | 1 (2%) |
| Adrenal insufficiency | 2 (3%) | 0 (0%) |
| Pancreatitis | 1 (2%) | 0 (0%) |
| Uveitis | 1 (2%) | 0 (0%) |
| Otherb | 18 (31%) | 0 (0%) |
a
One Nivolumab alone patient received simultaneous Cabozantinib and developed grade 3 pneumonitis, which was considered related to treatment.
b
This category included: shingles (1), headache (1), tinnitus (1), tachycardia (1), arthritis (2), cerebral radiation necrosis (1), paresthesia/neuropathy (2), thrush (1), pain flare after radiation (1), dysgeusia (1), dizziness (1), hearing loss (1), xerostomia (1), thrombocytopenia (1), vertebral fracture (1), and hot flashes (1).