Table 3 Signal strength of top 20 sonidegib-associated AEs at the preferred term (PT) level in FAERS database. The unexpected AEs are marked with bold font and asterisks. 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.
sonidegib | |||||||
|---|---|---|---|---|---|---|---|
SOC | PT | Case Reports | ROR (95% CI) | PRR(95% CI) | χ2 | IC(IC025) | EBGM (EBGM05) |
musculoskeletal and connective tissue disorders | muscle spasms | 127 | 18.61(15.56, 22.26) | 17.66(14.8, 21.07) | 1999.9 | 4.14(3.88) | 17.64(15.19) |
skin and subcutaneous tissue disorders | alopecia | 72 | 8.05(6.37, 10.18) | 7.84(6.2, 9.92) | 430.99 | 2.97(2.63) | 7.83(6.44) |
surgical and medical procedures | therapy cessation* | 50 | 19.02(14.37, 25.17) | 18.63(14.16, 4.51) | 834.25 | 4.22(3.82) | 18.61(14.72) |
nervous system disorders | ageusia | 42 | 46.3(34.11, 62.85) | 45.49(33.9, 61.04) | 1822.93 | 5.5(5.07) | 45.36(35.13) |
injury, poisoning and procedural complications | product dose omission issue* | 41 | 3.25(2.39, 4.43) | 3.21(2.39, 4.31) | 62.88 | 1.68(1.24) | 3.21(2.48) |
metabolism and nutrition disorders | decreased appetite | 39 | 4.16(3.03, 5.7) | 4.1(3, 5.61) | 91.89 | 2.04(1.59) | 4.1(3.15) |
investigations | blood creatine phosphokinase increased | 39 | 48.53(35.35, 66.63) | 47.75(34.9, 65.34) | 1779.98 | 5.57(5.12) | 47.6(36.51) |
investigations | weight decreased | 38 | 3.49(2.53, 4.8) | 3.45(2.52, 4.72) | 66.24 | 1.78(1.33) | 3.44(2.63) |
musculoskeletal and connective tissue disorders | myalgia | 37 | 5.96(4.3, 8.24) | 5.88(4.3, 8.05) | 150.12 | 2.55(2.09) | 5.88(4.48) |
nervous system disorders | dysgeusia | 33 | 12.13(8.6, 17.11) | 11.98(8.59, 16.72) | 332.17 | 3.58(3.09) | 11.97(8.98) |
surgical and medical procedures | therapy interrupted* | 28 | 9.09(6.26, 13.2) | 9(6.2, 13.06) | 199.2 | 3.17(2.64) | 8.99(6.58) |
general disorders and administration site conditions | disease progression | 25 | 5.47(3.69, 8.11) | 5.42(3.66, 8.02) | 90.21 | 2.44(1.88) | 5.42(3.89) |
musculoskeletal and connective tissue disorders | muscular weakness | 21 | 5.06(3.29, 7.78) | 5.02(3.26, 7.73) | 67.78 | 2.33(1.72) | 5.02(3.51) |
neoplasms benign, malignant and unspecified (incl cysts and polyps) | malignant neoplasm progression | 19 | 4.33(2.75, 6.79) | 4.3(2.74, 6.75) | 48.17 | 2.1(1.47) | 4.3(2.95) |
nervous system disorders | taste disorder | 19 | 19.51(12.42, 30.65) | 19.36(12.33, 30.39) | 330.57 | 4.27(3.64) | 19.34(13.25) |
blood and lymphatic system disorders | febrile neutropenia* | 17 | 6.45(4, 10.4) | 6.41(4, 10.26) | 77.7 | 2.68(2.01) | 6.41(4.3) |
general disorders and administration site conditions | therapeutic product effect incomplete | 15 | 3.94(2.37, 6.55) | 3.92(2.35, 6.53) | 32.74 | 1.97(1.26) | 3.92(2.57) |
investigations | blood creatinine increased | 10 | 4.42(2.37, 8.22) | 4.4(2.35, 8.24) | 26.32 | 2.14(1.28) | 4.4(2.62) |
metabolism and nutrition disorders | dehydration* | 9 | 4.02(2.09, 7.75) | 4(2.09, 7.64) | 20.27 | 2(1.1) | 4(2.31) |
neoplasms benign, malignant and unspecified (incl cysts and polyps) | triple negative breast cancer* | 8 | 383.82(190.08, 775.01) | 382.51(188.89, 774.61) | 2970.14 | 8.54(7.59) | 373.24(207.31) |
