TABLE 2.
Signal strength of reports of secukinumab at the System Organ Class (SOC) level in the FAERS database.
| System organ class (SOC) | Secukinumab cases reporting SOC | ROR (95%two-sided CI) | PRR (χ2) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|
| General disorders and administration site conditions | 40,825 | 1.30 (1.29–1.32) a | 1.17 (1559.78) | 0.22 (0.20) a | 1.16 (1.15) |
| Skin and subcutaneous tissue disorders | 30,047 | 2.65 (2.61–2.69) a | 2.09 (20096.13) a | 1.05 (1.03) a | 2.07 (2.04) a |
| Injury, poisoning and procedural complications | 24,402 | 0.93 (0.91–0.94) | 0.95 (101.12) | −0.08 (−0.10) | 0.95 (0.93) |
| Immune system disorders | 20,965 | 3.03 (2.98–3.07) a | 2.55 (21257.54) a | 1.33 (1.31) a | 2.51 (2.47) a |
| Infections and infestations | 19,387 | 2.25 (2.21–2.29) a | 1.98 (10340.17) | 0.97 (0.95) a | 1.96 (1.93) |
| Musculoskeletal and connective tissue disorders | 17,294 | 1.69 (1.66–1.72) a | 1.56 (3882.64) | 0.63 (0.61) a | 1.55 (1.52) |
| Respiratory, thoracic and mediastinal disorders | 15,948 | 1.29 (1.27–1.32) a | 1.24 (859.01) | 0.31 (0.28) a | 1.24 (1.22) |
| Gastrointestinal disorders | 12,951 | 0.76 (0.74–0.77) | 0.79 (842.05) | −0.33 (−0.36) | 0.80 (0.78) |
| Nervous system disorders | 11,740 | 0.55 (0.54–0.56) | 0.61 (3645.60) | −0.70 (−0.73) | 0.61 (0.60) |
| Vascular disorders | 8,642 | 0.56 (0.55–0.58) | 0.61 (2604.10) | −0.72 (−0.75) | 0.61 (0.60) |
| Psychiatric disorders | 6,381 | 0.52 (0.50–0.53) | 0.55 (2669.14) | −0.85 (−0.89) | 0.55 (0.54) |
| Cardiac disorders | 6,175 | 0.55 (0.54–0.57) | 0.58 (2071.19) | −0.77 (−0.81) | 0.59 (0.57) |
| Investigations | 5,453 | 0.49 (0.48–0.50) | 0.52 (2711.49) | −0.93 (−0.98) | 0.52 (0.51) |
| Product issues | 3,670 | 0.98 (0.95–1.01) | 0.98 (1.46) | −0.03 (−0.08) | 0.98 (0.95) |
| Renal and urinary disorders | 3,261 | 0.53 (0.51–0.55) | 0.55 (1298.92) | −0.86 (−0.91) | 0.55 (0.53) |
| Metabolism and nutrition disorders | 2,734 | 0.40 (0.39–0.42) | 0.42 (2320.40) | −1.24 (−1.29) | 0.42 (0.41) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2,709 | 0.41 (0.39–0.42) | 0.42 (2280.68) | −1.23 (−1.29) | 0.43 (0.41) |
| Eye disorders | 2,492 | 0.64 (0.62–0.67) | 0.65 (474.18) | −0.61 (−0.67) | 0.66 (0.63) |
| Reproductive system and breast disorders | 1,715 | 0.45 (0.43–0.47) | 0.46 (1127.11) | −1.11 (−1.18) | 0.46 (0.44) |
| Ear and labyrinth disorders | 1,610 | 1.40 (1.33–1.47) a | 1.39 (179.15) | 0.47 (0.40) a | 1.39 (1.32) |
| Blood and lymphatic system disorders | 1,293 | 0.29 (0.27–0.31) | 0.30 (2219.18) | −1.73 (−1.81) | 0.30 (0.29) |
| Surgical and medical procedures | 1,288 | 0.42 (0.40–0.44) | 0.43 (1008.86) | −1.21 (−1.29) | 0.43 (0.41) |
| Hepatobiliary disorders | 1,130 | 0.48 (0.46–0.51) | 0.49 (609.16) | −1.02 (−1.11) | 0.49 (0.47) |
| Endocrine disorders | 1,117 | 0.47 (0.44–0.50) | 0.48 (648.03) | −1.06 (−1.14) | 0.48 (0.45) |
| Pregnancy, puerperium and perinatal conditions | 671 | 0.41 (0.38–0.45) | 0.42 (549.87) | −1.25 (−1.36) | 0.42 (0.39) |
| Social circumstances | 220 | 0.21 (0.19–0.24) | 0.22 (632.00) | −2.20 (−2.40) | 0.22 (0.19) |
| Congenital, familial and genetic disorders | 95 | 0.18 (0.15–0.22) | 0.18 (346.84) | −2.44 (−2.73) | 0.18 (0.15) |
a
Indicates statistically significant signals in algorithm.
ROR, reporting odds ratio; CI, confidence interval; PRR, proportional reporting ratio; χ2, chi-squared; IC, information component; IC025, the lower limit of 95% CI of the IC; EBGM, empirical Bayesian geometric mean; EBGM05, the lower limit of 95% CI of EBGM.