Table 2 Signal strength of AEs of immune checkpoint inhibitors at the system organ class (SOC) level in FAERS database.
System Organ Class (SOC) | Cases (n) | ROR (95% two-sided CI) | PRR (χ2) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|
Gastrointestinal Disorders | 5157 | 0.92 (0.86,0.99) | 0.93 (5.39) | −0.08 (−1.74) | 0.95 (0.88) |
Metabolism and Nutrition Disorders | 1653 | 0.75(0.66,0.85) | 0.76 (21.64) | −0.31 (−1.98) | 0.81 (0.71) |
Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) | 1154 | 0.89 (0.78,1.03) | 0.90(2.48) | −0.12 (−1.79) | 0.92 (0.8) |
Injury, Poisoning and Procedural Complications | 2358 | 2.27 (2.08,2.47) * | 2.12 (365.54) * | 0.73 (−0.94) | 1.66 (1.52) |
Hepatobiliary Disorders | 524 | 0.93 (0.76,1.14) | 0.93 (0.54) | −0.08 (−1.75) | 0.94 (0.77) |
Nervous System Disorders | 2277 | 0.96 (0.87,1.06) | 0.96 (0.63) | −0.04 (−1.71) | 0.97 (0.88) |
Renal and Urinary Disorders | 963 | 0.78(0.66,0.91) | 0.78 (9.75) | −0.27 (−1.94) | 0.83 (0.71) |
Product Issues | 63 | 0.266 (0.1,0.65) | 0.26 (9.67) | −1.65 (−3.35) | 0.32 (0.13) |
Infections and Infestations | 1214 | 0.58 (0.5,0.68) | 0.59 (48.19) | −0.6 (−2.27) | 0.66 (0.57) |
Endocrine Disorders | 912 | 0.98 (0.84,1.15) | 0.98 (0.04) | −0.02 (−1.69) | 0.99 (0.85) |
Immune System Disorders | 292 | 0.46 (0.33,0.65) | 0.47 (20.83) | −0.9 (−2.57) | 0.54 (0.38) |
General Disorders and Administration Site Conditions | 4649 | 1.10 (1.02,1.18) * | 1.08 (6.69) | 0.09 (−1.58) | 1.06 (0.99) |
Skin and Subcutaneous Tissue Disorders | 1616 | 1.30 (1.16,1.45) * | 1.28 (21.97) | 0.26 (−1.41) | 1.2 (1.07) |
Musculoskeletal and Connective Tissue Disorders | 1534 | 1.69 (1.51,1.88) * | 1.64 (92.22) | 0.5 (−1.16) | 1.42 (1.27) |
Respiratory, Thoracic and Mediastinal Disorders | 1855 | 0.69 (0.61,0.78) | 0.70 (37.55) | −0.4 (−2.06) | 0.76 (0.67) |
Investigations | 3348 | 1.09 (1.01,1.18) * | 1.08 (4.45) | 0.08 (−1.58) | 1.06 (0.98) |
Reproductive System and Breast Disorders | 223 | 0.78 (0.57,1.09) | 0.79 (2.14) | −0.27 (−1.95) | 0.83 (0.6) |
Vascular Disorders | 1613 | 0.64 (0.56,0.73) | 0.65 (46.71) | −0.49 (−2.16) | 0.71 (0.62) |
Blood and Lymphatic System Disorders | 887 | 0.49 (0.41,0.6) | 0.50 (55.23) | −0.81 (−2.48) | 0.57 (0.47) |
Eye Disorders | 277 | 1.37 (1.06,1.76) * | 1.36 (5.75) | 0.32 (−1.35) | 1.25 (0.97) |
Cardiac Disorders | 718 | 0.54 (0.44,0.66) | 0.55 (35.65) | −0.7 (−2.37) | 0.62 (0.5) |
Surgical and Medical Procedures | 214 | 1.67 (1.26,2.21) * | 1.67 (13.12) | 0.52 (−1.16) | 1.43 (1.08) |
Psychiatric Disorders | 544 | 0.95 (0.78,1.16) | 0.95(0.27) | −0.06 (−1.73) | 0.96 (0.79) |
Ear and Labyrinth Disorders | 60 | 0.92 (0.51,1.68) | 0.92 (0.07) | −0.09 (−1.8) | 0.94 (0.52) |
Congenital, Familial and Genetic Disorders | 17 | 0.65 (0.19,2.26) | 0.65 (0.47) | −0.49 (−2.29) | 0.71 (0.2) |
Social Circumstances | 45 | 2.02 (1.11,3.67) * | 2.02 (5.54) * | 0.69 (−1.03) | 1.61 (0.89) |
