Table 2.
Treatment-emergent and treatment-related adverse events in the study population. Adverse events that were recorded in at least two patients are reported
| Study population (N = 18) |
||||||
|---|---|---|---|---|---|---|
| Treatment-emergent, n (%) |
Nivolumab-related, n (%) |
PIPAC-OX-related, n (%) |
||||
| Any grade, n (%) | Grade 3-5, n (%) | Any grade, n (%) | Grade 3-5, n (%) | Any grade, n (%) | Grade 3-5, n (%) | |
| Abdominal pain | 10 (55.6) | 0 (0.0) | 1 (5.6) | 0 (0.0) | 5 (27.8) | 0 (0.0) |
| Nausea/vomiting | 9 (50.0) | 1 (5.6) | 1 (5.6) | 0 (0.0) | 2 (11.1) | 1 (5.6) |
| Anorexia/weight loss/cachexia | 6 (33.3) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Diarrhea | 5 (27.8) | 0 (0.0) | 2 (11.1) | 0 (0.0) | 2 (11.1) | 0 (0.0) |
| Fatigue | 5 (27.8) | 0 (0.0) | 1 (5.6) | 0 (0.0) | 3 (16.7) | 0 (0.0) |
| Fever | 5 (27.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (11.1) | 0 (0.0) |
| Constipation | 4 (22.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Rash/urticaria | 3 (16.7) | 0 (0.0) | 1 (5.6) | 0 (0.0) | 1 (5.6) | 0 (0.0) |
| Dyspnea | 3 (16.7) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hypertension | 3 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dysphagia | 3 (16.7) | 2 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Anemia | 2 (11.1) | 2 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Intestinal perforation | 2 (11.1) | 2 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Abdominal distension/bloating/ascites | 2 (11.1) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 0 (0.0) |
| Cough | 2 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Electrolyte abnormality | 2 (11.1) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hepatitis/deranged liver function tests | 2 (11.1) | 2 (11.1) | 2 (11.1) | 1 (5.6) | 2 (11.1) | 2 (11.1) |
| Hydronephrosis/nephrostomy insertion | 2 (11.1) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Peripheral neuropathy | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 0 (0.0) |
| Sepsis | 1 (5.6) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Ureteral stent insertion | 1 (5.6) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hypothyroidism | 1 (5.6) | 0 (0.0) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Pleural effusion | 1 (5.6) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Thrombosis of the neck | 1 (5.6) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Lung infection | 1 (5.6) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Intestinal obstruction | 1 (5.6) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Bile duct compression | 1 (5.6) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hypotension | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 0 (0.0) |
| Hematoma | 1 (5.6) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Neutropenia | 1 (5.6) | 0 (0.0) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dyspepsia | 1 (5.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 0 (0.0) |
AE, adverse event; OX, oxaliplatin; PIPAC, pressurized intraperitoneal aerosol chemotherapy.