Table 2.
Treatment-emergent adverse events
| Total cohort (n = 18) | Cryoablation + iDC dose 1 (n = 3) | Cryoablation + iDC dose 2 (n = 3) | Cryoablation + iDC dose 3 (n = 3) | Cryoablation + iDC + CTLA-4i dose 1 (n = 3) | Cryoablation + iDC + CTLA-4i dose 2 (n = 3) | Cryoablation + iDC + PD-1i (n = 3) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | |
| Any treatment-emergent adverse event | 30 | 2 | 4 | 0 | 5 | 1 | 5 | 1 | 7 | 0 | 2 | 0 | 7 | 0 |
| Urinary retention | 6 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | ||||||
| Lower urinary tract infection | 1 | 0 | 1 | |||||||||||
| Urinary incontinence | 2 | 0 | 1 | 1 | ||||||||||
| Pollakiuria | 2 | 0 | 1 | 1 | ||||||||||
| Anemia | 1 | 0 | 1 | |||||||||||
| Nausea | 2 | 0 | 1 | 1 | ||||||||||
| Fecal incontinence | 2 | 0 | 1 | 1 | ||||||||||
| Constipation | 2 | 0 | 1 | 1 | ||||||||||
| Suprapubic pain | 1 | 0 | 1 | |||||||||||
| Rectal pain | 1 | 0 | 1 | |||||||||||
| Hemorrhoids | 1 | 0 | 1 | |||||||||||
| Bladder spasm | 1 | 0 | 1 | |||||||||||
| Influenza-like illness | 2 | 0 | 1 | 1 | ||||||||||
| Common cold | 2 | 0 | 1 | 1 | ||||||||||
| Sore throat | 1 | 0 | 1 | |||||||||||
| Dry mouth | 1 | 0 | 1 | |||||||||||
| Vitamin B12 deficiency | 1 | 0 | 1 | |||||||||||
| Osteomyelitis | 0 | 1 | 1 | |||||||||||
| Increased body rigidity | 1 | 0 | 1 | |||||||||||
| Angina pectoris | 1 | 0 | 1 | |||||||||||
| Facial rash | 1 | 0 | 1 | |||||||||||
Data are numbers in all treated patients. Treatment-emergent adverse events definitely, probably, or possibly attributed to cryoablation and/or iDC and/or PD-1i/CTLA-4i are shown. No grade 4 or grade 5 adverse events were attributed to treatment as definite, probable, or possible. iDC = immature dendritic cells. CTLA-4i = cytotoxic T-lymphocyte-associated protein 4 inhibitor. PD-1i = programmed cell death protein 1 inhibitor