Review of Food and Drug Administration adverse events reporting (pharmacovigilance database)
| Total adverse events (nivolumab, pembrolizumab, ipilimumab) | 50445 |
| Total T-cell related neoplasm AE | 12 |
| Sex | |
| Male | 8 |
| Female | 4 |
| Median age, years; no of patients for whom data was available | n=9 |
| Range (minimum/maximum) | 65 (51-87) |
| CPI used | |
| Nivolumab | 6 |
| Pembrolizumab | 3 |
| Nivolumab+ipilimumab | 2 |
| Ipilimumab | 1 |
| Indication for CPI use | |
| Lung cancer | 5 |
| Malignant melanoma | 3 |
| Hodgkin disease | 2 |
| Esophageal carcinoma | 1 |
| Renal cancer | 1 |
| Time to AE, months; no of patients for whom data were available | n=7 |
| Range (minimum/maximum) | 10.5 (1.33-121.5) |
| Outcome | |
| Death | 2 |
| Life threatening | 2 |
| Other outcome | 8 |
| Year event reported | |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 6 |
| Country where event occurred | |
| USA | 5 |
| Japan | 3 |
| Hong Kong | 1 |
| Spain | 1 |
| Brazil | 1 |
| Canada | 1 |
AE, adverse event; CPI, checkpoint inhibitor.