TABLE 3.
The top 40 signal strength of AEs of Everolimus at preferred terms (PTs) level ranked by EBGM in FDA Adverse Event Reporting System (FAERS) source.
| AEs | SOC | Case Reports | ROR (95% CI) | PRR (95% CI) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|
| angiofibroma | Musculoskeletal and connective tissue disorders | 12 | 193.29 (97.1-384.76) | 193.19 (97.07-384.48) | 7.03 (4.97) | 130.86 (65.74) |
| accidental exposure to product packaging | Injury, poisoning and procedural complications | 32 | 112.14 (75.78-165.95) | 112 (75.71-165.67) | 6.46 (5.21) | 87.83 (59.35) |
| biliary ischaemia | Vascular disorders | 6 | 219.59 (81.2-593.82) | 219.54 (81.2-593.58) | 7.15 (4.33) | 142.41 (52.66) |
| neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 109 | 72.71 (59.28-89.19) | 72.39 (59.06-88.74) | 5.94 (5.27) | 61.51 (50.14) |
| angiomyolipoma | Musculoskeletal and connective tissue disorders | 14 | 80.54 (45.37-142.99) | 80.5 (45.36-142.87) | 6.07 (4.29) | 67.25 (37.88) |
| tuberous sclerosis complex | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 9 | 92.91 (45-191.83) | 92.88 (45-191.72) | 6.24 (4.06) | 75.65 (36.64) |
| pancreatic neuroendocrine tumour | Endocrine disorders | 34 | 59.84 (41.73-85.81) | 59.76 (41.69-85.65) | 5.7 (4.55) | 52.16 (36.38) |
| urinary fistula | Renal and urinary disorders | 7 | 90.91 (40.03-206.47) | 90.88 (40.02-206.37) | 6.22 (3.79) | 74.33 (32.73) |
| concomitant disease progression | General disorders and administration site conditions | 78 | 42.21 (33.42-53.32) | 42.08 (33.34-53.12) | 5.26 (4.49) | 38.19 (30.24) |
| stomatitis | Gastrointestinal disorders | 1695 | 35.2 (33.44-37.04) | 32.84 (31.3-34.45) | 4.93 (4.76) | 30.44 (28.92) |
| neuroendocrine tumour of the lung | Endocrine disorders | 6 | 80.52 (33.51-193.46) | 80.5 (33.51-193.38) | 6.07 (3.52) | 67.25 (27.99) |
| lymphocele | Blood and lymphatic system disorders | 22 | 47.9 (30.78-74.55) | 47.86 (30.77-74.45) | 5.42 (4.02) | 42.88 (27.56) |
| lymphangioleiomyomatosis | Blood and lymphatic system disorders | 8 | 67.1 (31.74-141.86) | 67.08 (31.74-141.78) | 5.85 (3.61) | 57.64 (27.27) |
| hepatic artery stenosis | Vascular disorders | 6 | 58.91 (25.01-138.78) | 58.9 (25.01-138.72) | 5.69 (3.19) | 51.51 (21.87) |
| renal lymphocele | Blood and lymphatic system disorders | 3 | 92.89 (26.47-326) | 92.88 (26.47-325.92) | 6.24 (2.88) | 75.65 (21.56) |
| metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27 | 34.21 (23.09-50.68) | 34.17 (23.08-50.61) | 4.98 (3.72) | 31.58 (21.31) |
| pneumonitis | Respiratory, thoracic and mediastinal disorders | 531 | 25.04 (22.92-27.36) | 24.52 (22.48-26.74) | 4.53 (4.24) | 23.17 (21.21) |
| human herpesvirus 7 infection | Infections and infestations | 4 | 64.41 (22.41-185.08) | 64.4 (22.41-185.03) | 5.8 (2.86) | 55.65 (19.37) |
| lymphangiosis carcinomatosa | Blood and lymphatic system disorders | 27 | 29.89 (20.21-44.19) | 29.85 (20.2-44.13) | 4.8 (3.55) | 27.86 (18.84) |
| thoracic cavity drainage | Surgical and medical procedures | 9 | 38.96 (19.65-77.24) | 38.95 (19.65-77.2) | 5.15 (3.09) | 35.6 (17.96) |
| metastatic renal cell carcinoma | Renal and urinary disorders | 52 | 25.15 (19-33.29) | 25.09 (18.97-33.2) | 4.57 (3.65) | 23.68 (17.89) |
| rhabdomyoma | Musculoskeletal and connective tissue disorders | 3 | 71.04 (20.82-242.41) | 71.03 (20.82-242.35) | 5.92 (2.64) | 60.52 (17.74) |
| incisional hernia repair | Surgical and medical procedures | 4 | 57.51 (20.17-163.96) | 57.5 (20.17-163.91) | 5.66 (2.75) | 50.44 (17.69) |
| liver transplant rejection | Injury, poisoning and procedural complications | 43 | 25.53 (18.75-34.76) | 25.49 (18.73-34.68) | 4.59 (3.59) | 24.03 (17.65) |
| metastases to kidney | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18 | 30.59 (18.94-49.4) | 30.57 (18.93-49.35) | 4.83 (3.32) | 28.48 (17.63) |
| impaired insulin secretion | Endocrine disorders | 5 | 49.09 (19.4-124.24) | 49.08 (19.4-124.2) | 5.45 (2.81) | 43.86 (17.33) |
| renal hamartoma | Renal and urinary disorders | 5 | 47.92 (18.96-121.14) | 47.91 (18.96-121.1) | 5.42 (2.78) | 42.92 (16.98) |
| cholangiolitis | Hepatobiliary disorders | 3 | 67.09 (19.76-227.77) | 67.08 (19.76-227.72) | 5.85 (2.59) | 57.64 (16.98) |
| oncologic complication | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 30 | 25.67 (17.74-37.13) | 25.64 (17.73-37.07) | 4.59 (3.41) | 24.16 (16.7) |
| abdominal hernia repair | Surgical and medical procedures | 6 | 42.38 (18.27-98.29) | 42.37 (18.27-98.25) | 5.26 (2.82) | 38.43 (16.57) |
| oral pain | Gastrointestinal disorders | 403 | 19.16 (17.32-21.19) | 18.86 (17.08-20.82) | 4.17 (3.84) | 18.06 (16.33) |
| metastatic carcinoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 6 | 41.65 (17.97-96.53) | 41.64 (17.97-96.49) | 5.24 (2.8) | 37.83 (16.32) |
| lymphatic fistula | Injury, poisoning and procedural complications | 3 | 63.56 (18.81-214.8) | 63.55 (18.81-214.74) | 5.78 (2.53) | 55.02 (16.28) |
| endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16 | 28.39 (17.1-47.14) | 28.37 (17.09-47.09) | 4.73 (3.15) | 26.57 (16) |
| extubation | Surgical and medical procedures | 4 | 50.32 (17.79-142.29) | 50.31 (17.79-142.25) | 5.49 (2.6) | 44.83 (15.85) |
| drain removal | Surgical and medical procedures | 3 | 60.38 (17.94-203.21) | 60.37 (17.94-203.16) | 5.72 (2.48) | 52.63 (15.64) |
| cell marker increased | Investigations | 16 | 27.54 (16.59-45.7) | 27.52 (16.59-45.66) | 4.69 (3.11) | 25.82 (15.56) |
| metastases to liver | Hepatobiliary disorders | 290 | 18.38 (16.33-20.69) | 18.17 (16.17-20.43) | 4.12 (3.73) | 17.43 (15.49) |
| heart transplant rejection | Cardiac disorders | 22 | 25.25 (16.41-38.85) | 25.23 (16.4-38.8) | 4.57 (3.21) | 23.8 (15.47) |
| pancreatic neuroendocrine tumour metastatic | Endocrine disorders | 7 | 35.67 (16.47-77.28) | 35.66 (16.47-77.24) | 5.04 (2.76) | 32.84 (15.16) |