Table 1.
Neurologic immune-related adverse events reported with ICIs versus those reported in the full database from VigiBase, from Nov 14, 1967, to September 28, 2018
| Overall ICIs | Full database (starting 1967) | IC / IC025 | |
|---|---|---|---|
| Total number of ICSRs available | 48,653 | 18,518,994 | |
| Number of ICSRs by irAE subgroups | |||
| Neuromuscular junction dysfunction (myasthenia gravis) | 228 (0.47%) | 7455 (0.04%) | 3.51/3.31 |
| Noninfectious encephalitis and/or myelitis | 250 (0.51%) | 9267 (0.05%) | 3.33/3.15 |
| Cerebral artery vasculitis | 34 (0.07%) | 1206 (0.01%) | 3.23/2.71 |
| Peripheral neuropathy | 564 (1.16%) | 123,463 (0.67%) | 0.80/0.68 |
| - Guillain-Barre syndrome | 122 (0.25%) | 9508 (0.05%) | 2.27/2.00 |
| - Chronic polyneuropathies | 23 (0.05%) | 6428 (0.03%) | 0.43/−0.22 |
| - Mononeuropathies | 42 (0.09%) | 17,075 (0.09%) | −0.09/− 0.58 |
| Noninfectious meningitis | 72 (0.15%) | 10,532 (0.06%) | 1.36/1.01 |
| Hemorrhagic central nervous system vascular conditions | 386 (0.79%) | 195,577 (1.06%) | −0.41/− 0.56 |
| Cranial nerve disorders (excluding neoplasms) | 226 (0.46%) | 112,639 (0.61%) | −0.39/− 0.58 |
| Cerebral ischemia | 332 (0.68%) | 174,768 (0.94%) | −0.47/− 0.63 |
| Spinal cord and nerve root disorders | 27 (0.06%) | 11,875 (0.06%) | −0.21/− 0.80 |
| Speech and language abnormalities | 215 (0.44%) | 125,871 (%) | −0.62/− 0.82 |
| Seizures | 291 (0.60%) | 238,924 (0.68%) | −1.11/−1.28 |
| Headaches | 776 (1.59%) | 731,460 (3.95%) | −1.31/− 1.41 |
| Coma states | 56 (0.12%) | 43,228 (0.23%) | −1.01/− 1.41 |
| Extrapyramidal syndrome | 854 (1.76%) | 840,831 (4.54%) | −1.37/− 1.47 |
| Sensory abnormalities | 520 (1.07%) | 551,559 (2.98%) | −1.48/− 1.60 |
| Dementia | 21 (0.04%) | 15,706 (0.08%) | −0.96/−1.64 |
| Movement disorders | 396 (0.81%) | 427,006 (2.31%) | −1.50/− 1.65 |
| Vertigos | 89 (0.18%) | 91,034 (0.49%) | −1.42/− 1.74 |
| Nervous system neoplasms benign | 5 (0.01%) | 2302 (0.01%) | −0.25/−1.78 |
| Sleep disturbances | 239 (0.49%) | 314,528 (1.70%) | −1.79/− 1.98 |
| Psychosis and psychotic disorders | 183 (0.38%) | 284,048 (1.53%) | −2.03/−2.24 |
| Demyelinating disorders | 38 (0.08%) | 87,190 (0.47%) | −2.58/−3.07 |
Data are N (%) unless otherwise stated. ICIs refers to any ICSRs reported for treatment with nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, ipilimumab, or tremelimumab. A positive IC025 value (> 0) is the traditional threshold used in statistical signal detection with VigiBase. ICSRs individual case safety reports. ICIs immune checkpoint inhibitors. IC information component. IC025 = lower end of a 95% credibility interval for the IC
Bold text denotes statistically significant differences