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Table 2 Selected neurological adverse events (detected as signals) reported for ICIs versus the full database from VigiBase, from Jan 1, 2008, to September 28, 2018

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

Total number of ICSRs Overall ICIs (n:) Full database (full; starting 2008a; N:14,627,365) ROR and 95% CI [,] anti-PD-1 or anti-PD-L1 vs anti-CTLA-4 monotherapy ROR and 95% CI [,] combination ICIs vs monotherapy ROR and 95% CI [,] ICIs vs full database
MONO (N:43,960) COMB (N:4693)
MONO-PD1 (N:34,401) MONO-CTLA4 (N:9559)
Number of ICSRs by Neuro-ADR subgroup
 Neuromuscular junction dysfunction 197 (0.57%) 14 (0.15%) 17 (0.36%) 4380 (0.03%) 3.9 [2.3–6.8] 0.8 [0.5–1.2] 16.5 [14.5–18.9]
 Non-infectious encephalitis and/or myelitis 186 (0.54%) 21 (0.22%) 43 (0.92%) 7460 (0.05%) 2.5 [1.6–3.9] 2 [1.4–2.7] 10.4 [9.2–11.8]
 Guillain-Barre syndrome 64 (0.19%) 37 (0.39%) 21 (0.45%) 7962 (0.05%) 0.48 [0.32–0.72] 2 [1.2–3.1] 4.7 [3.9–5.6]
 Non-infectious meningitis 36 (0.10%) 20 (0.21%) 16 (0.34%) 6986 (0.04%) 0.5 [0.29–0.86] 2.7 [1.5–4.7] 3.1 [2.5–3.9]
  1. Abbreviations: Mono monotherapy, COMB combination therapy, PD1 Programmed death-1/ligand-1, CTLA4 cytotoxic T lymphocyte antigen-4
  2. Data are N (%) unless otherwise stated. ICIs refers to any ICSR reported for treatment with nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, ipilimumab, or tremelimumab. Anti-PD-1 or anti-PD-L1 monotherapy refers to any ICSR associated with any of the following five drugs only when used alone: nivolumab, pembrolizumab, atezolizumab, avelumab, or durvalumab. Anti-CTLA-4 monotherapy refers to any ICSR associated with ipilimumab or tremelimumab alone. Combination ICIs refers to any ICSR reported with at least one anti-PD-1 or anti-PD-L1 drug combined with an anti-CTLA-4 drug. ICSRs = individual case safety reports. ICIs = immune checkpoint inhibitors. ROR = reporting odds ratio
  3. aFirst reports of ICSRs associated with ICIs started in 2008
  4. Bold text denotes statistically significant differences