TABLE 2.
Signal strength of AEs of Everolimus at the System Organ Class (SOC) level in FDA Adverse Event Reporting System (FAERS) source.
| SOC Code | SOC | Case Reports | ROR (95% CI) | PRR (95% CI) | χ2 | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|---|
| 10022891 | Investigations | 3834 | 4.21 (4.06-4.36) | 3.71 (3.6-3.82) | 7843.61 | 1.88 (1.77) | 3.68 (3.56) |
| 10017947 | Gastrointestinal disorders | 4726 | 6.73 (6.52-6.95) | 5.63 (5.48-5.77) | 18361.74 | 2.48 (2.37) | 5.56 (5.39) |
| 10029104 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3515 | 11.85 (11.43-12.28) | 10.29 (9.98-10.62) | 29174.70 | 3.33 (3.21) | 10.06 (9.71) |
| 10038738 | Respiratory, thoracic and mediastinal disorders | 3588 | 4.85 (4.68-5.03) | 4.29 (4.16-4.42) | 9272.06 | 2.09 (1.97) | 4.25 (4.11) |
| 10038359 | Renal and urinary disorders | 892 | 5.28 (4.94-5.65) | 5.12 (4.8-5.47) | 2944.70 | 2.34 (2.12) | 5.07 (4.74) |
| 10018065 | General disorders and administration site conditions | 7492 | 4.92 (4.79-5.06) | 3.72 (3.65-3.8) | 16125.32 | 1.89 (1.8) | 3.7 (3.6) |
| 10042613 | Surgical and medical procedures | 306 | 3.49 (3.11-3.9) | 3.46 (3.09-3.86) | 531.45 | 1.78 (1.4) | 3.44 (3.07) |
| 10019805 | Hepatobiliary disorders | 575 | 8.68 (7.99-9.44) | 8.5 (7.84-9.22) | 3737.76 | 3.06 (2.78) | 8.35 (7.68) |
| 10021881 | Infections and infestations | 201 | 4.23 (3.68-4.86) | 4.2 (3.66-4.82) | 485.94 | 2.06 (1.59) | 4.17 (3.62) |
| 10038604 | Reproductive system and breast disorders | 211 | 10.27 (8.95-11.78) | 10.19 (8.89-11.67) | 1706.62 | 3.32 (2.86) | 9.96 (8.68) |
| 10005329 | Blood and lymphatic system disorders | 720 | 3.78 (3.51-4.07) | 3.7 (3.44-3.98) | 1417.38 | 1.88 (1.63) | 3.68 (3.41) |
| 10027433 | Metabolism and nutrition disorders | 1635 | 4.06 (3.86-4.27) | 3.85 (3.68-4.04) | 3483.30 | 1.94 (1.77) | 3.83 (3.64) |
| 10022117 | Injury, poisoning and procedural complications | 213 | 13.54 (11.81-15.53) | 13.44 (11.73-15.39) | 2373.91 | 3.7 (3.25) | 13.03 (11.36) |
| 10014698 | Endocrine disorders | 289 | 7.69 (6.84-8.65) | 7.61 (6.78-8.55) | 1631.98 | 2.91 (2.51) | 7.49 (6.66) |
| 10028395 | Musculoskeletal and connective tissue disorders | 337 | 14.85 (13.31-16.57) | 14.66 (13.16-16.34) | 4143.76 | 3.83 (3.46) | 14.18 (12.71) |
| 10040785 | Skin and subcutaneous tissue disorders | 446 | 4.89 (4.45-5.37) | 4.81 (4.39-5.28) | 1337.11 | 2.25 (1.94) | 4.77 (4.34) |
| 10007541 | Cardiac disorders | 931 | 4.18 (3.91-4.47) | 4.06 (3.81-4.33) | 2146.24 | 2.01 (1.79) | 4.03 (3.77) |
| 10047065 | Vascular disorders | 409 | 4.66 (4.23-5.14) | 4.6 (4.18-5.07) | 1144.16 | 2.19 (1.86) | 4.56 (4.13) |
| 10029205 | Nervous system disorders | 400 | 3.56 (3.22-3.93) | 3.51 (3.19-3.87) | 716.40 | 1.8 (1.47) | 3.49 (3.16) |
| 10021428 | Immune system disorders | 358 | 5.9 (5.31-6.56) | 5.83 (5.26-6.47) | 1415.85 | 2.53 (2.17) | 5.76 (5.19) |
| 10077536 | Product issues | 12 | 6.84 (3.87-12.11) | 6.84 (3.87-12.1) | 58.85 | 2.75 (1.01) | 6.74 (3.81) |
| 10037175 | Psychiatric disorders | 102 | 5.97 (4.91-7.26) | 5.95 (4.89-7.23) | 413.94 | 2.55 (1.91) | 5.88 (4.83) |
| 10010331 | Congenital, familial and genetic disorders | 5 | 17.5 (7.15-42.86) | 17.5 (7.15-42.84) | 74.54 | 4.07 (1.54) | 16.81 (6.87) |
| 10015919 | Eye disorders | 4 | 8.26 (3.07-22.22) | 8.26 (3.07-22.22) | 25.00 | 3.02 (0.33) | 8.11 (3.01) |