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SAEs as Individually Reported
| SAE description | Events, n | Causality determined by IDMC |
|---|---|---|
| New ascites | 1 | Unrelated |
| Renal impairment | 1 | Unrelated |
| Variceal bleeding (death) | 3 | Unrelated |
| Variceal bleeding (death) | 1 | Unlikely to be related |
| Pneumonia (death) | 1 | Unrelated |
| Death (decompensated cirrhosis) | 4 | Unrelated |
| Bronchogenic carcinoma and pleural effusion (death) | 1 | Unrelated |
