TABLE 3.
Distribution for seriousness and outcomes of cardiovascular events reported in ICSRs with ibrutinib and/or obinutuzumab as suspected drug.
| Number of events with ibrutinib (n = 2514; 86.22%) | Number of events with obinutuzumab (n = 383; 13.13%) | Number of events with ibrutinib/obinutuzumab (n = 19; 0.65%) | Number of cardiovascular events (n = 2916; 100%) | |
|---|---|---|---|---|
| Seriousness | ||||
| Not available | 176 (7.00) | 49 (12.79) | — | 225 (7.72) |
| Serious | 2338 (93.00) | 334 (87.21) | 19 (100%) | 2691 (92.28) |
| Seriousness Criteria | ||||
| Other Medically Important Condition | 1061 (42.20) | 133 (34.73) | 5 (26.32) | 1199 (41.12) |
| Results in Death | 256 (10.18) | 58 (15.14) | 4 (21.05) | 318 (10.91) |
| Caused/Prolonged Hospitalisation | 862 (34.28) | 116 (30.29) | 10 (52.63) | 988 (33.88) |
| Life Threatening | 142 (5.65) | 27 (7.05) | — | 169 (5.80) |
| Disabling | 17 (0.68) | — | — | 17 (0.57) |
| Outcome | ||||
| Recovered/Resolved | 569 (22.63) | 158 (41.25) | 4 (21.05) | 731 (25.07) |
| Recovering/Resolving | 246 (9.79) | 16 (4.18) | — | 262 (8.98) |
| Recovered/Resolved with Sequelae | 22 (0.88) | 3 (0.79) | — | 25 (0.86) |
| Not Recovered/Not Resolved | 327 (13.00) | 16 (4.18) | 2 (10.53) | 345 (11.83) |
| Fatal | 256 (10.18) | 58 (15.14) | 4 (21.05) | 318 (10.91) |
| Unknown | 1094 (43.52) | 132 (34.46) | 9 (47.37) | 1235 (42.35) |