Table 1.

Summary of serious adverse events during long‐term (3‐year) follow‐up^a

Any SAE, n/N (%)	13/40 (32.5%)
SAE related to any study therapy, n/N (%)	0
SAE with fatal outcome, n/N (%)	1/40 (2.5%)
Preferred term	Onset from start of treatment
CP A patients (n = 4) b
Cerebrovascular accident	Day 427
Hepatic lesionc	Day 702
Skin ulcer (worsening)	Day 514
Diverticulitis	Day 832
Gastrointestinal stromal tumor	Day 920
CP B patients (n = 9) d
Hepatic encephalopathy	Day 692
Abdominal pain	Day 573
Abdominal pain	Day 1031
Encephalopathy	Day 1141
Ascites	Day 949
Ascites	Day 1121
De novo hepatocellular carcinoma	Day 949
De novo hepatocellular carcinoma	Day 367
De novo hepatocellular carcinoma	Day 921
De novo hepatocellular carcinoma	Day 1017
GI hemorrhage	Day 685
Death (upper GI bleed)	Day 729

Abbreviations: CP, Child–Pugh; GI, gastrointestinal; SAE, serious adverse event.

^aCollected between the Week 24 and 3‐year follow‐up visits.

^bOne patient had 2 SAEs: skin ulcer (worsening) and gastrointestinal stromal tumor.

^cBenign arteriovenous malformation.

^dOne patient had three SAEs: two incidences of ascites, and de novo hepatocellular carcinoma; and, one patient had two SAEs: abdominal pain and de novo hepatocellular carcinoma.