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Table 2 Serious adverse events
| Study | No. of patients | No. of patients/events with SAE | Description of SAE (comments from investigator) |
|---|---|---|---|
| Beinhardt (2016) [27] | 10 | 5 (5/5 on dialysis) | 1 pt.: recurring peritonitis |
| 1 pt.: renal anemia | |||
| 1 pt.: graft failure after orthotopic liver transplantation (LOT) | |||
| 1 pt.: cirrhosis due to HCV recurrence after OLT | |||
| 1 PT: pneumonia | |||
| Goel (2018) [23] | 41 | 2 (0/2 on dialysis) | 1 pt.: acute mild pancreatitis after renal transplantation |
| 1 pt.: worsening of ascites | |||
| Lawitz (2017) [33] | 18 | 4 (0/4 on dialysis) | 1 pt.: acute kidney injury and noncardiac chest pain |
| 1 pt.: dehydration and hypotension | |||
| 1 pt.: acute renal failure | |||
| 1 pt.: hypotension and synocope (no SAEs were considered related to study drug) | |||
| Saxena (2015) [47] | 18 | 3 | NA |
| Cox-North (2017) [35] | 29 | 1 (1/1 on dialysis) | 1 pt.: cardiac event (unable to draw any conclusions about the safety of SOF regimens in those with underlying cardiac disease) |
