Table 3 Signal detection at the SOC level in FAERS
Syetem organ class | Cases | ROR(95%CI) | PRR(χ2) | EBGM(EBGM05) | IC(IC025) |
|---|---|---|---|---|---|
General disorders and administration site conditions | 454 | 1.06 (0.96–1.18) | 1.05 (1.42) | 1.05 (0.97) | 0.07 (-1.59) |
Reproductive system and breast disorders | 411 | 21.16 (19.03–23.53) | 17.75 (6549.08) | 17.72 (16.22) | 4.15 (2.48) |
Injury, poisoning and procedural complications | 312 | 1.48 (1.31–1.66) | 1.41 (41.61) | 1.41 (1.28) | 0.5 (-1.17) |
Gastrointestinal disorders | 312 | 1.48 (1.32–1.67) | 1.42 (42.82) | 1.42 (1.29) | 0.51 (-1.16) |
Product issues | 172 | 4.55 (3.89–5.31) | 4.3 (442.09) | 4.29 (3.77) | 2.1 (0.44) |
Respiratory, thoracic and mediastinal disorders | 117 | 1 (0.83–1.21) | 1 (0) | 1 (0.86) | 0 (-1.66) |
Nervous system disorders | 106 | 0.47 (0.39–0.57) | 0.49 (60.13) | 0.49 (0.42) | -1.02 (-2.68) |
Skin and subcutaneous tissue disorders | 97 | 0.67 (0.55–0.82) | 0.68 (15.37) | 0.68 (0.57) | -0.55 (-2.22) |
Pregnancy, puerperium and perinatal conditions | 88 | 6.43 (5.2–7.96) | 6.23 (388.81) | 6.23 (5.22) | 2.64 (0.97) |
Investigations | 46 | 0.31 (0.23–0.41) | 0.32 (70.17) | 0.32 (0.25) | -1.64 (-3.31) |
Musculoskeletal and connective tissue disorders | 41 | 0.26 (0.19–0.36) | 0.28 (82.23) | 0.28 (0.21) | -1.85 (-3.52) |
Infections and infestations | 36 | 0.27 (0.19–0.37) | 0.28 (71.95) | 0.28 (0.21) | -1.85 (-3.52) |
Vascular disorders | 35 | 0.71 (0.51–0.99) | 0.71 (4.24) | 0.71 (0.54) | -0.49 (-2.16) |
Immune system disorders | 34 | 1.17 (0.83–1.64) | 1.17 (0.82) | 1.17 (0.88) | 0.22 (-1.44) |
Surgical and medical procedures | 28 | 0.85 (0.59–1.24) | 0.85 (0.71) | 0.85 (0.62) | -0.23 (-1.9) |
Psychiatric disorders | 25 | 0.18 (0.12–0.27) | 0.19 (91.14) | 0.19 (0.14) | -2.39 (-4.06) |
Metabolism and nutrition disorders | 22 | 0.45 (0.3–0.69) | 0.46 (14.4) | 0.46 (0.32) | -1.13 (-2.79) |
Renal and urinary disorders | 19 | 0.54 (0.35–0.86) | 0.55 (7.16) | 0.55 (0.38) | -0.87 (-2.53) |
Cardiac disorders | 18 | 0.33 (0.21–0.53) | 0.34 (24.26) | 0.34 (0.23) | -1.58 (-3.24) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 11 | 0.21 (0.12–0.38) | 0.21 (32.85) | 0.21 (0.13) | -2.24 (-3.9) |
Blood and lymphatic system disorders | 9 | 0.26 (0.13–0.5) | 0.26 (19.06) | 0.26 (0.15) | -1.94 (-3.6) |
Eye disorders | 8 | 0.15 (0.07–0.3) | 0.15 (38.47) | 0.15 (0.09) | -2.71 (-4.38) |
Hepatobiliary disorders | 6 | 0.3 (0.13–0.66) | 0.3 (9.9) | 0.3 (0.15) | -1.74 (-3.41) |
Endocrine disorders | 4 | 0.64 (0.24–1.71) | 0.64 (0.8) | 0.64 (0.28) | -0.64 (-2.31) |
Congenital, familial and genetic disorders | 3 | 0.56 (0.18–1.75) | 0.56 (1.02) | 0.56 (0.22) | -0.83 (-2.5) |