Table 1.
FAERS heart block cases
| Number (n) | Percent (%) | |
|---|---|---|
| Sex (n = 15 cases reporting data) | ||
| Female | 7 | 47 |
| Male | 8 | 53 |
| Disease (n = 14) | ||
| CLL | 12 | 86 |
| WM | 2 | 14 |
| Conduction disorder (n = 15) | ||
| Third-degree block | 5 | 33 |
| Second-degree (Mobitz II) | 9 | 60 |
| SA block | 1 | 7 |
| Event within 1 year (n = 15) | ||
| <12 months | 11 | 73 |
| >12 months | 4 | 27 |
| Pacemaker (n = 13) | ||
| Yes | 13 | 100 |
| Restart ibrutinib (n = 13) | ||
| Yes | 8 | 62 |
| No | 5 | 38 |
Patient characteristics for 15 FAERS database cases reported between 2014 and 2020, including 5 with complete heart block. All reporting cases underwent pacemaker placement and 62% of evaluable patients restarted ibrutinib. One case did not provide ibrutinib indication and 2 each did not report pacemaker status or ibrutinib resumption.
CLL = chronic lymphocytic leukemia; SA = sinoatrial; WM = Waldenstrom macroglobulinemia.