Table 3.
Signal strength of reports of sotorasib at the System Organ Class (SOC) level in FAERS database.
| System Organ Class (SOC) | Cases | ROR (95 % two-sided CI) | PRR (χ2) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|
| General disorders and administration site conditions | 576 | 0.95 (0.86–1.05) | 0.97 (1.01) | −0.05 (−0.18) | 0.97 (0.87) |
| Respiratory, thoracic and mediastinal disorders | 444 | 2.25 (2.02–2.51)a | 1.89 (219.4) | 0.92 (0.76)a | 1.89 (1.69) |
| Neoplasms benign, malignant and unspecified | 380 | 2.09 (1.86–2.35)a | 1.82 (162.5) | 0.86 (0.69)a | 1.82 (1.62) |
| Gastrointestinal disorders | 312 | 1.13 (0.99–1.27) | 1.10 (3.48) | 0.14 (−0.04) | 1.10 (0.97) |
| Injury, poisoning and procedural complications | 217 | 0.37 (0.32–0.42) | 0.46 (202.81) | −1.13 (−1.34) | 0.46 (0.40) |
| Hepatobiliary disorders | 182 | 4.48 (3.84–5.23)a | 4.07 (433.49)a | 2.02 (1.77)a | 4.07 (3.48)a |
| Investigations | 178 | 1.02 (0.87–1.19) | 1.02 (0.05) | 0.02 (−0.21) | 1.02 (0.87) |
| Nervous system disorders | 112 | 0.35 (0.28–0.42) | 0.39 (128.8) | −1.35 (−1.63) | 0.39 (0.32) |
| Metabolism and nutrition disorders | 98 | 0.97 (0.79–1.19) | 0.97 (0.07) | −0.04 (−0.35) | 0.97 (0.79) |
| Cardiac disorders | 90 | 0.55 (0.45–0.68) | 0.58 (30.91) | −0.79 (−1.11) | 0.58 (0.47) |
| Musculoskeletal and connective tissue disorders | 90 | 0.46 (0.38–0.57) | 0.50 (52.35) | −1.01 (−1.33) | 0.50 (0.40) |
| Vascular disorders | 80 | 0.35 (0.28–0.44) | 0.39 (89.4) | −1.37 (−1.70) | 0.39 (0.31) |
| Infections and infestations | 64 | 0.31 (0.24–0.39) | 0.34 (96.44) | −1.58 (−1.95) | 0.34 (0.26) |
| Skin and subcutaneous tissue disorders | 52 | 0.21 (0.16–0.28) | 0.24 (148.34) | −2.07 (−2.49) | 0.24 (0.18) |
| Psychiatric disorders | 49 | 0.22 (0.17–0.30) | 0.25 (129.35) | −2.02 (−2.44) | 0.25 (0.19) |
| Surgical and medical procedures | 48 | 0.81 (0.61–1.08) | 0.81 (2.10) | −0.30 (−0.74) | 0.81 (0.61) |
| Blood and lymphatic system disorders | 43 | 0.51 (0.38–0.70) | 0.53 (19.20) | −0.92 (−1.39) | 0.53 (0.39) |
| Renal and urinary disorders | 32 | 0.26 (0.19–0.38) | 0.28 (64.10) | −1.84 (−2.36) | 0.28 (0.20) |
| Immune system disorders | 27 | 0.16 (0.11–0.24) | 0.18 (112.18) | −2.48 (−3.05) | 0.18 (0.12) |
| Endocrine disorders | 10 | 0.28 (0.15–0.52) | 0.28 (18.68) | −1.82 (−2.78) | 0.28 (0.15) |
| Eye disorders | 7 | 0.10 (0.05–0.22) | 0.11 (53.73) | −3.21 (−4.32) | 0.11 (0.05) |
| Product issues | 7 | 0.09 (0.04–0.19) | 0.09 (64.41) | −3.41 (−4.53) | 0.09 (0.04) |
| Reproductive system and breast disorders | 6 | 0.06 (0.03–0.13) | 0.06 (91.59) | −4.02 (−5.22) | 0.06 (0.03) |
| Congenital, familial and genetic disorders | 3 | 0.38 (0.12–1.17) | 0.38 (3.10) | −1.41 (−3.25) | 0.38 (0.12) |
| Ear and labyrinth disorders | 1 | 0.05 (0.01–0.38) | 0.05 (16.73) | −4.21 (−7.17) | 0.05 (0.01) |
| Pregnancy, puerperium and perinatal conditions | 1 | 0.04 (0.01–0.26) | 0.04 (24.87) | −4.72 (−7.66) | 0.04 (0.01) |
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.