Table 4 Signal strength of top 20 vismodegib-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.
vismodegib | |||||||
|---|---|---|---|---|---|---|---|
SOC | PT | Case Reports | ROR (95% CI) | PRR (95% CI) | χ2 | IC(IC025) | EBGM (EBGM05) |
musculoskeletal and connective tissue disorders | muscle spasms | 1870 | 33.6(32.03, 35.25) | 30.5(29.33, 31.72) | 52797.1 | 4.91(4.84) | 30.1(28.92) |
skin and subcutaneous tissue disorders | alopecia | 1264 | 18.88(17.83, 19.99) | 17.73(16.72, 18.8) | 19870.73 | 4.14(4.06) | 17.6(16.78) |
nervous system disorders | ageusia | 930 | 137.57(128.57, 147.2) | 131.11(123.62, 139.05) | 113440.28 | 6.95(6.86) | 123.87(117.05) |
general disorders and administration site conditions | fatigue | 862 | 3.28(3.07, 3.52) | 3.18(3, 3.37) | 1308.07 | 1.67(1.57) | 3.18(3) |
nervous system disorders | dysgeusia | 678 | 29.58(27.38, 31.95) | 28.59(26.43, 30.92) | 17844.45 | 4.82(4.71) | 28.24(26.48) |
investigations | weight decreased | 659 | 7.46(6.9, 8.06) | 7.24(6.69, 7.83) | 3549.07 | 2.85(2.74) | 7.22(6.76) |
metabolism and nutrition disorders | decreased appetite | 631 | 8.21(7.59, 8.89) | 7.98(7.38, 8.63) | 3855.66 | 2.99(2.88) | 7.96(7.45) |
gastrointestinal disorders | constipation | 354 | 5.07(4.56, 5.63) | 5(4.53, 5.51) | 1133.25 | 2.32(2.17) | 4.99(4.57) |
general disorders and administration site conditions | no adverse event | 223 | 3.71(3.25, 4.24) | 3.68(3.21, 4.22) | 436.15 | 1.88(1.69) | 3.68(3.29) |
nervous system disorders | taste disorder | 209 | 31.61(27.56, 36.26) | 31.28(27.27, 35.88) | 6044.25 | 4.95(4.75) | 30.86(27.52) |
musculoskeletal and connective tissue disorders | myalgia | 186 | 3.47(3.01, 4.01) | 3.45(3.01, 3.96) | 324.12 | 1.79(1.58) | 3.45(3.05) |
neoplasms benign, malignant and unspecified (incl cysts and polyps) | squamous cell carcinoma* | 100 | 41.21(33.8, 50.25) | 41(33.7, 49.88) | 3832.75 | 5.33(5.05) | 40.28(34.12) |
metabolism and nutrition disorders | dehydration* | 71 | 4.74(3.69, 6.09) | 4.7(3.64, 6.06) | 181.03 | 2.23(1.87) | 4.7(3.81) |
skin and subcutaneous tissue disorders | madarosis* | 49 | 10.5(7.93, 13.91) | 10.48(7.97, 13.79) | 418.1 | 3.38(2.98) | 10.43(8.25) |
investigations | neutrophil count decreased* | 47 | 3.48(2.61, 4.64) | 3.48(2.59, 4.67) | 82.81 | 1.8(1.39) | 3.47(2.73) |
nervous system disorders | hypogeusia | 43 | 75.65(55.81, 102.56) | 75.49(56.26, 101.29) | 3057.12 | 6.19(5.76) | 73.05(56.63) |
nervous system disorders | anosmia* | 43 | 12.67(9.39, 17.11) | 12.65(9.43, 16.97) | 458.68 | 3.65(3.23) | 12.58(9.79) |
ear and labyrinth disorders | deafness* | 31 | 3.63(2.55, 5.17) | 3.63(2.55, 5.17) | 58.99 | 1.86(1.36) | 3.63(2.7) |
hepatobiliary disorders | hepatotoxicity | 30 | 4.28(2.99, 6.12) | 4.27(3, 6.08) | 75.09 | 2.09(1.58) | 4.27(3.16) |
investigations | lymphocyte count decreased* | 29 | 4.49(3.12, 6.46) | 4.48(3.09, 6.5) | 78.33 | 2.16(1.64) | 4.48(3.3) |
