TABLE 2.
Cardiovascular events categorized by HLGTs listed in ICSRs with ibrutinib and/or obinituzumab as suspected drug and reported in Eudravigilance from January 1st. 2014 to September 30st. 2022.
| HLGT | Ibrutinib | Ibrutinib/Obinituzumab | Obinituzumab | Total |
|---|---|---|---|---|
| Aneurysms and artery dissections | 12 | 0 | 0 | 12 |
| Arteriosclerosis, stenosis, vascular insufficiency and necrosis | 33 | 0 | 6 | 39 |
| Cardiac arrhythmias | 1241 | 8 | 95 | 1344 |
| Cardiac disorders, signs and symptoms NEC | 94 | 2 | 18 | 114 |
| Cardiac valve disorders | 17 | 0 | 3 | 20 |
| Coronary artery disorders | 102 | 1 | 43 | 146 |
| Decreased and nonspecific blood pressure disorders and shock | 73 | 2 | 118 | 193 |
| Embolism and thrombosis | 57 | 2 | 2 | 61 |
| Heart failures | 186 | 1 | 14 | 201 |
| Lymphatic vessel disorders | 14 | 0 | 1 | 15 |
| Myocardial disorders | 65 | 1 | 2 | 68 |
| Pericardial disorders | 97 | 0 | 1 | 98 |
| Vascular disorders NEC | 29 | 0 | 41 | 70 |
| Vascular haemorrhagic disorders | 321 | 0 | 5 | 326 |
| Vascular hypertensive disorders | 157 | 2 | 33 | 192 |
| Vascular infections and inflammations | 14 | 0 | 1 | 15 |
| Venous varices | 2 | 0 | 0 | 2 |