Table 1.
Demographic and clinical characteristics of Individual Case Safety Reports reporting ADRs related to the System Organ Class “Nervous system disorder” or “Psychiatric disorders” and having alirocumab or evolocumab as suspect drugs sent through the Eudravigilance database from January 2015 to March 2020
| Variable | Level | All ICSRs [n = 2041] | ICSRs reporting alirocumab as the suspect drug [n = 856] | ICSRs reporting evolocumab as the suspect drug [n = 1231] |
|---|---|---|---|---|
| Age, years | Median (IQR) | 66 (59–73) | 67 (59–73) | 66 (58–72) |
| Sex | Female | 1121 (55) | 475 (55.5) | 668 (54.3) |
| Male | 864 (42.3) | 357 (41.7) | 525 (42.6) | |
| Missing | 56 (2.7) | 24 (2.8) | 38 (3.1) | |
| Seriousness | Serious | 1359 (66.6) | 556 (65) | 835 (67.8) |
| Not serious | 682 (33.4) | 300 (35) | 396 (32.2) | |
| Primary source qualification | Healthcare professional | 1475 (72.3) | 433 (50.6) | 1078 (87.6) |
| Non-healthcare professional | 566 (27.7) | 423 (49.4) | 153 (12.4) | |
| Primary source country for regulatory purposes | European Economic Area | 912 (44.7) | 389 (45.4) | 551 (44.8) |
| Non-European Economic Area | 1129 (55.3) | 467 (54.6) | 680 (55.2) | |
| Suspected drug(s) other than PCSK9I | 0 | 1917 (94) | 790 (92.3) | 1128 (91.6) |
| 1 | 83 (4) | 53 (6.2) | 71 (5.8) | |
| 2 | 24 (1.2) | 11 (1.3) | 17 (1.4) | |
| 3 | 6 (0.3) | – | 6 (0.5) | |
| 4 | 5 (0.2) | – | 5 (0.4) | |
| ≥ 5 | 6 (0.3) | 2 (0.2) | 4 (0.3) | |
| Concomitant drug(s) | 0 | 1246 (61.1) | 527 (61.6) | 749 (60.9) |
| 1 | 148 (7.3) | 52 (6.1) | 96 (7.8) | |
| 2 | 119 (5.8) | 44 (5.1) | 79 (6.4) | |
| 3 | 84 (4.1) | 40 (4.7) | 46 (3.7) | |
| 4 | 79 (3.9) | 37 (4.3) | 44 (3.6) | |
| ≥ 5 | 365 (17.8) | 156 (18.2) | 217 (17.6) |
Data are expressed as n (%) unless otherwise specified
ICSRs Individual Case Safety Reports, IQR interquartile range, PCSK9I proprotein convertase subtilisin/kexin type 9 inhibitor