Table 1 Clinical characteristics of MSAE reports associated with CDK4/6 inhibitors in the FAERS database between 2015 Q1 and 2023 Q4
Palbociclib (N = 7819) | Ribociclib (N = 1895) | Abemaciclib (N = 381) | All (N = 10095) | |
|---|---|---|---|---|
Age (median, IQR) | 65.00 (57.00,73.00) | 58.00 (48.00,68.00) | 61.00 (54.00,70.00) | 64.00 (55.00,72.00) |
Sex | ||||
Female | 7667 (98.06) | 1849 (97.57) | 350 (91.86) | 9866 (97.73) |
Male | 79 (1.01) | 21 (1.11) | 6 (1.57) | 106 (1.05) |
Unknown | 73 (0.93) | 25 (1.32) | 25 (6.56) | 123 (1.22) |
Reporter | ||||
Consumer | 3326 (42.54) | 1258 (66.39) | 223 (58.53) | 4807 (47.62) |
Pharmacist | 2514 (32.15) | 218 (11.50) | 69 (18.11) | 2801 (27.75) |
Other health-professional | 1181 (15.10) | 43 (2.27) | 23 (6.04) | 1247 (12.35) |
Physician | 738 (9.44) | 363 (19.16) | 39 (10.24) | 1140 (11.29) |
Unknown | 60 (0.77) | 13 (0.68) | 27 (7.08) | 100 (0.99) |
Outcomes | ||||
Death | 286 (5.60) | 192 (8.52) | 4 (2.12) | 482 (6.38) |
Hospitalization | 1274 (24.94) | 562 (24.94) | 75 (39.68) | 1911 (25.31) |
Disability | 45 (0.88) | 50 (2.22) | 4 (2.12) | 99 (1.31) |
Life threatening | 37 (0.72) | 101 (4.48) | 5 (2.65) | 143 (1.89) |
Required intervention to prevent permanent impairment | 6 (0.12) | 1 (0.04) | 1 (0.53) | 8 (0.11) |
Congenital anomaly | 1 (0.02) | NA | NA | 1 (0.01) |
Other | 3459 (67.72) | 1347 (59.79) | 100 (52.91) | 4906 (64.98) |
Reported countries | ||||
United States | 6576 (84.10) | 364 (19.21) | 281 (73.75) | 7221 (71.53) |
India | 356 (4.55) | 76 (4.01) | No data | 433 (4.29) |
Argentina | 338 (4.32) | 90 (4.75) | No data | 433 (4.29) |
Brazil | No data | 213 (11.24) | No data | 226 (2.24) |
Colombia | 62 (0.79) | 103 (5.44) | No data | 166 (1.64) |
Others | 488 (6.24) | 1049 (55.35) | 100 (26.25) | 1616 (16.01) |