Table 1.
Clinical characteristics of AC-DILI cases
| Cohorts | DILIGEN | EUDRAGENE | Spanish DILI Registry | DILIN | All (%) | |
|---|---|---|---|---|---|---|
| N | 77 | 19 | 49 | 56 | 201 | |
| Sex | M | 39 (51%) | 11 (58%) | 27 (55%) | 36 (64%) | 113 (56%) |
| F | 38 (49%) | 8 (42%) | 22 (45%) | 20 (36%) | 88 (44%) | |
| Age | Mean (±stdev) | 61 (± 14) | 68 (± 14) | 60 (± 18) | 59 (± 14) | 61 (± 14) |
| Total days on drug | Mean (±stdev) | 8 (± 6) | 7 (± 5) | 11 (± 9) | 12 (± 8) | 10 (± 7) |
| Days to DILI onset | Mean (±stdev) | 15 (± 14) | 11 (± 9) | 16 (± 12) | 32 (± 19) | 20 (± 17) |
| Pattern of liver injury | Cholestatic | 36 (47%) | 6 (32%) | 17 (35%) | 20 (36%) | 79(39%) |
| Mixed | 18 (23%) | 5 (26%) | 17 (35%) | 23 (41%) | 63 (31%) | |
| Hepatocellular | 19 (25%) | 0 | 15 (31%) | 10 (18%) | 44 (22%) | |
| Unknown | 4 (5%) | 8 (42%) | 0 | 3 (5%) | 15 (7%) | |
| Causality (CIOMS) | Unlikely | 0 | 0 | 0 | 0 | 0 |
| Possible | 7 (9%) | 1 (5%) | 0 | 6 (11%) | 14 (7%) | |
| Probable | 25 (32%) | 12 (63%) | 23 (47%) | 37 (66%) | 97 (48%) | |
| Highly probable | 45 (58%) | 6 (32%) | 26 (53%) | 13 (23%) | 90 (45%) | |
| Peak Bilirubin (mg/dL) | Mean (±stdev) | 12.5 (±9.8) | 10.8 (±12.2) | 12.3 (±9.5) | 16.5 (±11.8) | 13.5 (±10.6) |
| Peak ALT (U/L) | Mean (±stdev) | 455 (±465) | 342 (±268) | 548 (±668) | 575 (±713) | 500 (±584) |
| Peak ALP (U/L) | Mean (±stdev) | 453 (±253) | 438 (±171) | 417 (±286) | 456 (±293) | 444 (±268) |