TABLE 4.
Top 10 SOCs for lecanemab by report frequency in FAERS.
| SOC | Number of reports | ROR (95% CI) | PRR (χ2) | EBGM (EBGM05) | IC (IC025) |
|---|---|---|---|---|---|
| Nervous system disorders | 1867 | 8.3 (7.83–8.79) | 5.45 (7,292.46) | 5.44 (5.13) | 2.44 (2.36) |
| General disorders and administration site conditions | 902 | 1.09 (1.01–1.17) | 1.07 (5.01) | 1.07 (1.00) | 0.1 (−0.01) |
| Injury, poisoning and procedural complications | 337 | 0.48 (0.43–0.53) | 0.51 (179.92) | 0.51 (0.46) | −0.96 (−1.12) |
| Psychiatric disorders | 318 | 1.46 (1.30–1.63) | 1.43 (42.50) | 1.43 (1.27) | 0.51 (0.34) |
| Gastrointestinal disorders | 306 | 0.77 (0.69–0.87) | 0.79 (19.29) | 0.79 (0.70) | −0.35 (−0.52) |
| Investigations | 166 | 0.59 (0.50–0.68) | 0.6 (46.75) | 0.6 (0.51) | −0.74 (−0.96) |
| Infections and infestations | 125 | 0.41 (0.34–0.49) | 0.43 (102.15) | 0.43 (0.36) | −1.23 (−1.48) |
| Musculoskeletal and connective tissue disorders | 119 | 0.47 (0.39–0.57) | 0.49 (68.30) | 0.49 (0.40) | −1.04 (−1.30) |
| Skin and subcutaneous tissue disorders | 117 | 0.43 (0.36–0.51) | 0.44 (87.22) | 0.44 (0.37) | −1.18 (−1.44) |
| Respiratory, thoracic and mediastinal disorders | 93 | 0.41 (0.33–0.50) | 0.42 (79.04) | 0.42 (0.34) | −1.26 (−1.55) |
Abbreviations: SOC, system organ class; ROR, reporting odds ratio; PRR, proportional reporting ratio; EBGM, empirical Bayes geometric mean; IC, information component; CI, confidence interval; IC025, lower limit of 95% CI, of IC; EBGM05, lower limit of 95% CI, of EBGM.