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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

From: Neurologic toxicity associated with immune checkpoint inhibitors: a pharmacovigilance study

  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
  1. 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
  2. Bold text denotes statistically significant differences