Table 6.

Severe adverse events (SAE)

Serious Adverse Events (SAE)	Placebo (n=22)	Etanercept (n=26)	p-value*
Patients with any SAE, n (%)	9 (41%)	18 (69%)	0.049
GI bleeding, n (%)	2 (9.1%)	3 (11.5%)	1.0
Renal failure, n (%)	4 (18.2%)	11 (42.3%)	0.12
Cardiopulmonary failure, n (%)	1 (4.5%)	1 (3.8%)	1.0
Hepatic encephalopathy, n (%)	6 (27.3%)	9 (34.6%)	0.76
Infection, n (%)	2 (9.1%)	9 (34.6%)	0.04
-Pneumonia, n	2	2
-Urinary tract infection, n	0	2
-SBP, n	0	3
-Sepsis, n	0	3
-Catheter infection, n	0	1

^*Significance test by Fisher’s exact test.

Each SAE represents one patient experiencing that particular event.

Each patient may have more than one SAE or infection, resulting in totals that exceed 100%.