Table 1 Clinical characteristics of reports with sonidegib and vismodegib from the FAERS database (Q1 2012 to Q3 2024).
characteristics | sonidegib | vismodegib |
|---|---|---|
total | 1020(100%) | 7650(100%) |
age_yr | 73.00(63.00,83.00) | 72.00(61.00,83.00) |
age_yrQ | ||
<18 | 5(0.49%) | 24(0.31%) |
18 ~ 65 | 148(14.51%) | 1090(14.25%) |
>=65 | 385(37.75%) | 2284(29.86%) |
unknow | 482(47.25%) | 4252(55.58%) |
Indications | ||
basal cell carcinoma | 606(58.83%) | 4895(63.87%) |
small cell lung cancer | 34(0.44%) | |
squamous cell carcinoma of skin | 31(0.40%) | |
others | 141(13.69%) | 548(7.15%) |
basal cell naevus syndrome | 89(1.16%) | |
product used for unknown indication | 240(23.30%) | 1403(18.31%) |
congenital anomaly | 42(0.55%) | |
unknown | 43(4.17%) | 43(0.56%) |
malignant melanoma | 30(0.39%) | |
medulloblastoma | 45(0.59%) | |
neoplasm malignant | 101(1.32%) | |
skin cancer | 403(5.26%) | |
Reporter (Top 5) | ||
Consumer | 440(43.14%) | 3941(51.52%) |
Pharmacist | 220(21.57%) | 731(9.56%) |
Physician | 207(20.29%) | 2261(29.56%) |
unknown | 91(8.92%) | 144(1.88%) |
Other health-professional | 62(6.08%) | 570(7.45%) |
Outcomes (Top 5) | ||
other serious | 316(51.89%) | 1444(42.81%) |
hospitalization | 188(30.87%) | 929(27.54%) |
death | 78(12.81%) | 843(24.99%) |
disability | 17(2.79%) | 70(2.08%) |
life threatening | 9(1.48%) | 85(2.52%) |
Reported countries (Top 5) | ||
United States | 714(70.00%) | 6882(89.96%) |
other | 136(13.33%) | 354(4.63%) |
Germany | 92(9.02%) | 77(1.01%) |
France | 159(2.08%) | |
Italy | 78(7.65%) | 56(0.73%) |
Canada | 71(0.93%) | |
route | ||
oral | 610(59.80%) | 5584(72.99%) |
other | 410(40.20%) | 2066(27.01%) |
sex | ||
female | 343(33.63%) | 2821(36.88%) |
male | 557(54.61%) | 4316(56.42%) |
unknown | 120(11.76%) | 513(6.71%) |
weight | 70.31(60.00,85.00) | 73.48(62.10,86.26) |
Year | ||
2012 | 69(0.90%) | |
2013 | 187(2.44%) | |
2014 | 245(3.20%) | |
2015 | 8(0.78%) | 402(5.25%) |
2016 | 22(2.16%) | 591(7.73%) |
2017 | 25(2.45%) | 1401(18.31%) |
2018 | 69(6.76%) | 794(10.38%) |
2019 | 77(7.55%) | 745(9.74%) |
2020 | 69(6.76%) | 692(9.05%) |
2021 | 71(6.96%) | 635(8.30%) |
2022 | 109(10.69%) | 694(9.07%) |
2023 | 121(11.86%) | 667(8.72%) |
2024 | 449(44.02%) | 528(6.90%) |
