Table 2.
TESAEs by System Organ Class Reported by More Than 2 ELAD Subjects
| System Organ Class Serious Adverse Events Preferred Term | Subjects Reporting at Least 1 Serious Adverse Event | |
|---|---|---|
| ELAD (n = 95) | Control (n = 108) | |
| Blood and lymphatic system disorders | ||
| Anemia | 8 (8.4) | 6 (5.6) |
| Coagulopathy | 3 (3.2) | 0 (0.0) |
| General disorders and administration site conditions | ||
| Multiorgan failure | 7 (7.4) | 10 (9.3) |
| Hepatobiliary disorders | ||
| Ascites | 6 (6.3) | 13 (12.0) |
| Hepatic failure | 13 (13.7) | 10 (9.3) |
| Hepatorenal syndrome | 3 (3.2) | 9 (8.3) |
| Infections and infestations | ||
| Sepsis | 4 (4.2) | 2 (1.9) |
| Nervous system disorders | ||
| Hepatic encephalopathy | 8 (8.4) | 6 (5.6) |
| Renal and urinary disorders | ||
| Renal failure | 4 (4.2) | 1 (0.9) |
| Renal failure acute | 6 (6.3) | 12 (11.1) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Respiratory failure | 5 (5.3) | 2 (1.9) |
| Vascular disorders | ||
| Gastrointestinal hemorrhage | 7 (7.4) | 6 (5.6) |
NOTE: Data are given as n (%). These data reflect the safety population (see flowchart in Fig. 2). The number of subjects experiencing system organ class–related serious events and the percentage of subjects is shown. According to Good Clinical Practice Guidelines for Safety Reporting, the determination of seriousness was based on whether the event met one of the following criteria: life threatening, lead to hospital admission and or prolonged hospitalization, upgraded the subject to intensive care, led to death or continued disability, resulted in congenital/birth defects or the event was serious in the opinion of the investigator. Reported serious events were reviewed by a blinded DSMB. In case of a disagreement with the investigator's assessment, the investigator was informed and final assessment required consensus.