Table 4.

Most frequent adverse events and severe adverse events in the treated (ornithine phenylacetate) and placebo group during treatment infusion (5 first days) and follow-up period (FU, 28 days).

	Placebo n = 18 patients,n (%) infusion/FU	OP n = 20 patients, n (%) infusion/FU
Organ system preferred term, AE reported in at least in 5% patients
Investigators
Hypokalemia	1 (5.5) | 1/0	9 (45) | 7/2
Hyponatremia	3 (16.7) | 3/0	2 (10) | 2/0
Alkaline phosphatase increased	0	2 (10) | 0/2
Gastrointestinal disorders
Abdominal pain	3 (16.7) | 2/1	1 (5) | 0/1
Diarrhoea	2 (11.1) | 1/1	1 (5) | 0/1
Nausea	0	2 (10) | 2/0
Metabolism and nutrition disorders
Hyperglycemia	5 (27.8) | 5/0	8 (40) | 7/1
Asthenia	3 (16.7) | 0/3	0
Hypocalcemia	2 (11.1) | 2/0	0
Blood and lymphatic system disorders
Leukopenia	2 (11.1) | 1/1	1 (5)|1/0
Lymphopenia	3 (16.7) | 2/1	0
Neutropenia	1 (5.5) | 1/0	3 (15) | 3/0
Nervous system disorders
Dizziness	2 (11.1) | 1/1	0
Musculoskeletal disorders
Cramps	0	2 (10) | 0/2
Vascular disorders
Hypertension	2 (11.1) | 2/0	0
General disorders and administration-site conditions
Pyrexia	6 (33.3) | 2/4	3 (15) | 1/2
Psychiatric disorders
Anxiety	0	2 (10) | 1/1
Cirrhosis related
Ascites	2 (11.1) | 1/1	0
Edemas	2 (11.1) | 1/1	1 (5) | 1/0
Any SAE
Procedural complication
Hemorrhagic shock post TIPS	0	1 (5) | 0/1
Upper-gastrointestinal hemorrhage	1 (5.5) | 0/1	2 (10) | 0/1
Cirrhosis related
Hepatic encephalopathy	0	1 (5) | 0/1
Nervous system disorders
Seizures due to cerebellar hemorrhage	1 (5.5) | 0/1	0
Subdural hematoma	1 (5.5) | 0/1	0
Infections
Respiratory-tract infection	1 (5.5) | 0/1	1 (5) | 0/1
Blood and lymphatic-system disorders
Neutropenia	0	1* (5) | 1/0

AE, adverse event; SAE, severe adverse event; TIPS; transyugular porto-systemic shunt; FU, follow up; OP, ornithyne phenylactetate.

^*Causality relationship between study medication and SAE was not established.