Table 4 Newly discovered AEs signals of ipilimumab and nivolumab combination in the FAERS database, only cases > 10 are displayed.
SOC | PTs | N | ROR (95%Cl) | PRR (χ2) | EBGM (EBGM05) | IC(IC025) | Expected |
|---|---|---|---|---|---|---|---|
Cardiac disorders | Sinus tachycardia | 43 | 3.34(2.47–4.5) | 3.33(70.05) | 3.33(2.59) | 1.73(0.07) | NO |
Atrioventricular block complete | 34 | 5.68(4.06–7.96) | 5.68(130.34) | 5.65(4.26) | 2.5(0.83) | NO | |
Ear and labyrinth disorders | Deafness bilateral | 11 | 7.42(4.1-13.42) | 7.42(60.59) | 7.37(4.48) | 2.88(1.21) | NO |
Endocrine disorders | Inappropriate antidiuretic hormone secretion | 30 | 3.43(2.39–4.9) | 3.43(51.34) | 3.42(2.53) | 1.77(0.11) | NO |
Thyrotoxic crisis | 26 | 31.18(21.1-46.08) | 31.17(735.47) | 30.22(21.8) | 4.92(3.25) | NO | |
Diabetes insipidus | 11 | 5(2.76–9.04) | 5(34.98) | 4.98(3.03) | 2.31(0.65) | NO | |
Eye disorders | Eyelid ptosis | 42 | 4.87(3.59–6.59) | 4.86(128.3) | 4.84(3.76) | 2.28(0.61) | NO |
Papilloedema | 19 | 4.7(3-7.38) | 4.7(55.13) | 4.69(3.21) | 2.23(0.56) | NO | |
Gastrointestinal disorders | Ileus paralytic | 13 | 3.32(1.93–5.73) | 3.32(21.02) | 3.31(2.1) | 1.73(0.06) | NO |
Hepatobiliary disorders | Cholecystitis | 54 | 5.17(3.96–6.75) | 5.16(180.43) | 5.14(4.11) | 2.36(0.7) | NO |
Biliary obstruction | 13 | 4.73(2.74–8.16) | 4.73(38.07) | 4.71(2.99) | 2.24(0.57) | NO | |
Portal vein thrombosis | 12 | 4.22(2.39–7.44) | 4.22(29.32) | 4.2(2.61) | 2.07(0.4) | NO | |
Infections and infestations | Bronchopulmonary aspergillosis | 22 | 3.27(2.15–4.98) | 3.27(34.62) | 3.27(2.3) | 1.71(0.04) | NO |
Sialoadenitis | 19 | 15.93(10.12–25.07) | 15.93(261.5) | 15.69(10.73) | 3.97(2.3) | NO | |
Investigations | Blood creatine phosphokinase mb increased | 12 | 9.36(5.3-16.52) | 9.35(88.67) | 9.27(5.76) | 3.21(1.55) | NO |
Metabolism and nutrition disorders | Failure to thrive | 18 | 3.74(2.35–5.94) | 3.74(35.97) | 3.73(2.53) | 1.9(0.23) | NO |
Hyperuricaemia | 14 | 3.8(2.25–6.42) | 3.79(28.7) | 3.78(2.44) | 1.92(0.25) | NO | |
Nervous system disorders | Facial paralysis | 82 | 6.33(5.09–7.86) | 6.32(364.8) | 6.28(5.24) | 2.65(0.99) | NO |
Altered state of consciousness | 74 | 4(3.18–5.03) | 4(165.68) | 3.98(3.29) | 1.99(0.33) | NO | |
Brain oedema | 59 | 5.23(4.05–6.76) | 5.23(200.58) | 5.2(4.2) | 2.38(0.71) | NO | |
Radiculopathy | 19 | 5.67(3.61–8.91) | 5.67(72.68) | 5.64(3.87) | 2.5(0.83) | NO | |
Spinal cord compression | 15 | 4.18(2.51–6.93) | 4.17(36.06) | 4.16(2.72) | 2.06(0.39) | NO | |
Bell’S palsy | 11 | 10.76(5.94–19.5) | 10.76(96.3) | 10.65(6.48) | 3.41(1.74) | NO | |
Renal and urinary disorders | Nephrotic syndrome | 25 | 4.16(2.81–6.16) | 4.16(59.77) | 4.15(2.98) | 2.05(0.39) | NO |
Immune-Mediated cystitis | 13 | 262.05(141.98-483.67) | 261.99(2659.61) | 206.37(123.58) | 7.69(5.98) | NO | |
Respiratory, thoracic and mediastinal disorders | Atelectasis | 29 | 3.2(2.22–4.6) | 3.19(43.58) | 3.19(2.35) | 1.67(0.01) | NO |
Lung opacity | 20 | 11.12(7.15–17.28) | 11.11(181.97) | 11(7.6) | 3.46(1.79) | NO | |
Skin and subcutaneous tissue disorders | Dermatomyositis | 12 | 5.48(3.11–9.67) | 5.48(43.74) | 5.46(3.39) | 2.45(0.78) | NO |
Vascular disorders | Thrombophlebitis migrans | 18 | 46.57(29.02–74.74) | 46.56(765.57) | 44.46(29.93) | 5.47(3.8) | NO |
Giant cell arteritis | 14 | 9.82(5.8-16.62) | 9.81(109.71) | 9.73(6.26) | 3.28(1.61) | NO | |
Capillary leak syndrome | 13 | 7.6(4.4-13.11) | 7.59(73.86) | 7.54(4.78) | 2.92(1.25) | NO |
