Table 5 The top 30 signal strength of AEs of brodalumab ranked by EBGM at the PT level in FAERS database.
From: Analysis and mining of brodalumab adverse events based on FAERS database
SOC | PT | Case reports | ROR(95% CI) | PRR(95% CI) | chisq | IC(IC025) | EBGM(EBGM05) |
|---|---|---|---|---|---|---|---|
General disorders and administration site conditions | Injection site vesicles | 4 | 2291.56 (689.83, 7612.33) | 2289.91 (692.75, 7569.39) | 6101.09 | 10.58 (9.09) | 1526.94 (559.19) |
General disorders and administration site conditions | Injection site hemorrhage | 4 | 632.15 (222.16, 1798.78) | 631.7 (223.55, 1785.07) | 2213.5 | 9.12 (7.76) | 555.25 (231.46) |
Metabolism and nutrition disorders | Calcium metabolism disorder | 3 | 259.37 (81.03, 830.28) | 259.23 (81.56, 823.95) | 730.38 | 7.94 (6.48) | 245.4 (92.7) |
Investigations | Psoriasis area severity index increased | 4 | 205.98 (75.62, 561.11) | 205.83 (75.75, 559.28) | 780.29 | 7.62 (6.32) | 197.02 (85.18) |
General disorders and administration site conditions | Vaccination site erythema | 3 | 112.68 (35.83, 354.35) | 112.62 (36.13, 351.01) | 323.92 | 6.78 (5.34) | 109.94 (42.15) |
Skin and subcutaneous tissue disorders | Palmoplantar pustulosis | 8 | 99.43 (49.33, 200.42) | 99.29 (49.03, 201.07) | 761.91 | 6.6 (5.65) | 97.21 (54.07) |
Skin and subcutaneous tissue disorders | Erythrodermic psoriasis | 4 | 67.65 (25.2, 181.61) | 67.6 (25.37, 180.12) | 258.64 | 6.06 (4.78) | 66.63 (29.16) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Extranodal marginal zone b-cell lymphoma (malt type) | 3 | 63.94 (20.45, 199.88) | 63.9 (20.5, 199.16) | 183.21 | 5.98 (4.55) | 63.04 (24.29) |
Infections and infestations | Tinea pedis | 7 | 56.02 (26.57, 118.09) | 55.95 (26.57, 117.83) | 373.22 | 5.79 (4.78) | 55.29 (29.62) |
Skin and subcutaneous tissue disorders | Pustular psoriasis | 12 | 49.62 (28.07, 87.69) | 49.51 (28.04, 87.41) | 564.31 | 5.61 (4.82) | 48.99 (30.42) |
Gastrointestinal disorders | Coating in mouth | 3 | 49.1 (15.73, 153.2) | 49.07 (15.74, 152.94) | 139.77 | 5.6 (4.18) | 48.56 (18.74) |
Injury, poisoning and procedural complications | Paternal exposure during pregnancy | 4 | 32.85 (12.28, 87.87) | 32.83 (12.32, 87.47) | 122.57 | 5.03 (3.76) | 32.6 (14.31) |
General disorders and administration site conditions | Symptom recurrence | 17 | 21.82 (13.54, 35.17) | 21.76 (13.59, 34.83) | 335.15 | 4.44 (3.77) | 21.66 (14.53) |
Musculoskeletal and connective tissue disorders | Psoriatic arthropathy | 95 | 21.41 (17.47, 26.24) | 21.06 (17.31, 25.62) | 1808.68 | 4.39 (4.1) | 20.97 (17.69) |
Skin and subcutaneous tissue disorders | Psoriasis | 283 | 21.32 (18.91, 24.04) | 20.29 (18.04, 22.82) | 5179.66 | 4.34 (4.16) | 20.2 (18.28) |
Musculoskeletal and connective tissue disorders | Dactylitis | 3 | 20.19 (6.49, 62.76) | 20.18 (6.47, 62.9) | 54.44 | 4.33 (2.91) | 20.09 (7.78) |
Infections and infestations | Oral fungal infection | 4 | 18.37 (6.88, 49.06) | 18.36 (6.89, 48.92) | 65.38 | 4.19 (2.92) | 18.29 (8.04) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Cholangiocarcinoma | 3 | 17.06 (5.49, 53.01) | 17.05 (5.47, 53.14) | 45.15 | 4.09 (2.67) | 16.99 (6.58) |
Psychiatric disorders | Mental fatigue | 3 | 16.46 (5.3, 51.16) | 16.45 (5.28, 51.27) | 43.39 | 4.04 (2.62) | 16.4 (6.35) |
Musculoskeletal and connective tissue disorders | Limb mass | 5 | 15.99 (6.64, 38.5) | 15.98 (6.61, 38.6) | 69.97 | 3.99 (2.84) | 15.93 (7.64) |
Skin and subcutaneous tissue disorders | Skin weeping | 5 | 15.95 (6.63, 38.39) | 15.94 (6.6, 38.51) | 69.75 | 3.99 (2.83) | 15.88 (7.62) |
Infections and infestations | Skin infection | 17 | 15.05 (9.34, 24.25) | 15.01 (9.38, 24.03) | 221.62 | 3.9 (3.23) | 14.96 (10.04) |
Respiratory, thoracic and mediastinal disorders | Pleurisy | 6 | 13.82 (6.2, 30.8) | 13.8 (6.18, 30.82) | 71.04 | 3.78 (2.71) | 13.76 (7.04) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Lung adenocarcinoma | 4 | 13.73 (5.14, 36.65) | 13.72 (5.15, 36.56) | 47.04 | 3.77 (2.51) | 13.68 (6.02) |
Skin and subcutaneous tissue disorders | Skin atrophy | 7 | 12.76 (6.07, 26.8) | 12.74 (6.05, 26.83) | 75.54 | 3.67 (2.67) | 12.71 (6.83) |
Investigations | Thyroid function test abnormal | 4 | 12.14 (4.55, 32.4) | 12.13 (4.55, 32.32) | 40.75 | 3.6 (2.33) | 12.1 (5.32) |
Infections and infestations | Oral candidiasis | 13 | 11.93 (6.92, 20.57) | 11.9 (6.87, 20.6) | 129.49 | 3.57 (2.81) | 11.87 (7.52) |
Injury, poisoning and procedural complications | Intentional dose omission | 35 | 11.89 (8.52, 16.58) | 11.82 (8.47, 16.49) | 345.96 | 3.56 (3.09) | 11.79 (8.93) |
General disorders and administration site conditions | Disease recurrence | 70 | 11.71 (9.25, 14.83) | 11.58 (9.15, 14.65) | 675.43 | 3.53 (3.19) | 11.55 (9.48) |
Eye disorders | Uveitis | 17 | 11.22 (6.97, 18.08) | 11.19 (6.99, 17.91) | 157.45 | 3.48 (2.81) | 11.17 (7.49) |
