Table 1 Baseline characteristics of cardiovascular toxicity records associated with amivantamab in FAERS from 2019–2023.
Non cardiovascular toxicity (N = 497) | Any cardiovascular toxicity (N = 98) | P | Non-MACE (N = 88) | MACE (N = 10) | P | |
|---|---|---|---|---|---|---|
Sex | ||||||
Female (%) | 206 (41.45) | 58 (59.18) | 0.238 | 54 (61.36) | 4 (40.00) | 0.152 |
Male (%) | 143 (28.77) | 30 (30.61) | 25 (28.41) | 5 (50.00) | ||
Unknown (%) | 148 (29.78) | 10 (10.20) | 9 (10.23) | 1 (10.00) | ||
Age | ||||||
Median (Q1, Q3)* | 64 (56, 71) | 66 (56, 71) | 65 (56, 70.5) | 69 (60, 73.5) | ||
18–45 (%) | 13 (2.62) | 3 (3.06) | 0.743 | 2 (2.27) | 1 (10.00) | 0.234 |
45–65 (%) | 114 (22.94) | 32 (32.65) | 31 (35.23) | 1 (10.00) | ||
65–75 (%) | 76 (15.29) | 28 (28.57) | 24 (27.27) | 4 (40.00) | ||
≥ 75 (%) | 36 (7.24) | 13 (13.27) | 11 (12.50) | 2 (20.00) | ||
Unknown (%) | 258 (51.91) | 22 (22.45) | 20 (22.73) | 2 (20.00) | ||
Type of reporter | ||||||
Doctor (%) | 273 (54.93) | 70 (71.43) | 0.005 | 61 (69.32) | 9 (90.00) | 0.384 |
Pharmacist (%) | 185 (37.22) | 26 (26.53) | 25 (28.41) | 1 (10.00) | ||
Consumer (%) | 39 (7.85) | 2 (2.04) | 2 (2.27) | 0 (0) | ||
Year of report | ||||||
2021 (%) | 74 (14.89) | 8 (8.16) | 0.100 | 7 (7.95) | 1 (10.00) | 0.404 |
2022 (%) | 222 (44.67) | 41 (41.84) | 35 (39.77) | 6 (60.00) | ||
2023 (%) | 201 (40.44) | 49 (50.00) | 46 (52.27) | 3 (30.00) | ||
State of the reporting country | ||||||
North America (%) | 291 (58.55) | 33 (33.67) | < 0.001 | 31 (35.23) | 2 (20.00) | 0.271 |
Asia (%) | 120 (24.14) | 41 (41.84) | 34 (38.64) | 7 (70.00) | ||
Europe (%) | 67 (13.48) | 16 (16.33) | 15 (17.05) | 1 (10.00) | ||
South America (%) | 17 (3.42) | 8 (8.16) | 8 (9.09) | 0 (0) | ||
Oceania (%) | 2 (0.40) | 0 (0) | 0 (0) | 0 (0) | ||
Serious outcome | ||||||
Serious (%) | 320 (64.39) | 85 (86.73) | < 0.001 | 75 (85.23) | 10 (100.0) | 0.350 |
Non-serious (%) | 177 (35.61) | 13 (13.27) | 13 (14.77) | 0 (0) | ||
Death | ||||||
Yes (%) | 50 (10.06) | 16 (16.33) | 0.478 | 10 (11.36) | 6 (60.00) | 0.002 |
No (%) | 270 (54.33) | 69 (70.40) | 65 (73.86) | 4 (40.00) | ||
Unknown (%) | 177 (35.61) | 13 (13.27) | 13 (14.77) | 0 (0) | ||
Hospitalization—initial or prolonged | ||||||
Yes (%) | 172 (34.61) | 60 (61.22) | 0.005 | 55 (62.50) | 5 (50.00) | 0.128 |
No (%) | 148 (29.78) | 25 (25.51) | 20 (22.73) | 5 (50.00) | ||
Unknown (%) | 177 (35.61) | 13 (13.27) | 13 (14.77) | 0 (0) | ||
Life-threatening | ||||||
Yes (%) | 34 (6.84) | 16 (16.33) | 0.041 | 10 (11.36) | 6 (60.00) | 0.002 |
No (%) | 286 (57.55) | 69 (70.40) | 65 (73.86) | 4 (40.00) | ||
Unknown (%) | 177 (35.61) | 13 (13.27) | 13 (14.77) | 0 (0) | ||
