Table 4.
Adverse events
| Standard care | G-CSF only | G-CSF plus CD133-positive cell infusion | |
|---|---|---|---|
| Deaths | |||
| Event 1 | Variceal bleed (2·3 months) | ·· | Myocardial infarction (3·9 months) |
| Event 2 | ·· | ·· | Progressive liver disease (8·9 months) |
| Assessed for liver transplant | |||
| Event 1 | Assessed due to decompensation (7·9 months); not listed due to ventricular tachycardias on electrocardiogram | Assessed and listed due to decompensation (1·7 months); transplanted (4·3 months) | Assessed and listed due to decompensation (3·9 months); transplanted (10·2 months) |
| Event 2 | ·· | Assessed and listed due to decompensation (4·9 months); transplanted (16·9 months) | Assessed and listed due to decompensation (10·0 months); transplanted (13·6 months) |
| Event 3 | ·· | Assessed and listed due to poor synthetic function (5·1 months); listed but removed due to improvement | Assessed and listed due to decompensation (10·5 months); not transplanted |
| Event 4 | ·· | Assessed and listed due to decompensation (12·0 months); transplanted (15·0 months) | ·· |
| Serious adverse events | |||
| Event 1 | Hypoglycaemia (2·4 months)* | Oesophageal variceal bleed (2·1 months)* | Diarrhoea and pulmonary sepsis (0·8 months) |
| Event 2 | Hepatic decompensation (2·3 months) and later died | Urinary retention and ascites (1·7 months)* | Sepsis and encephalopathy (2·3 months);* acute kidney injury (2·8 months)* |
| Event 3 | ·· | Hepatic decompensation and ascites (3·0 months)* | Cardiac failure (5·8 months)* |
| Event 4 | ·· | ·· | Ascites and encephalopathy (0·7 months);* ascites and encephalopathy (2·3 months)* |
| Event 5 | ·· | ·· | Abdominal sepsis (0·3 months)* |
| Event 6 | ·· | ·· | Peripheral oedema (1·7 months)* |
| Event 7 | ·· | ·· | Sepsis and ascites (1·6 months)* |
| Event 8 | ·· | ·· | Encephalopathy (2·0 months)* |
Unless indicated otherwise, events represent different patients within the study. G-CSF=granulocyte colony-stimulating factor.
*
Resolved with no sequelae.