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Table 3 Serious adverse events due to protocol treatment in the sorafenib group and the HAIC group

From: Randomized, phase II trial of sequential hepatic arterial infusion chemotherapy and sorafenib versus sorafenib alone as initial therapy for advanced hepatocellular carcinoma: SCOOP-2 trial

 

Sorafenib group (n = 33)

HAIC group (n = 35)

HAIC

sorafenib

(n = 23)

Adverse events

Grade 3/4

Grade 3/4

n (%)

n (%)

Non-hematological

 Mucositis oral

1 (3)

 

1 (4)

 Hoarseness

0 (0)

 

1 (4)

 Hand-foot skin reaction

5 (15)

 

6 (26)

 Rash

2 (6)

 

0 (0)

 Anorexia

1 (3)

 

2 (9)

 Diarrhea

1 (3)

 

0 (0)

 Bleeding

1 (3)

 

1 (4)

 Fatigue

1 (3)

 

1 (4)

 Hypertension

6 (18)

 

8 (35)

 Somnolence

1 (3)

 

0 (0)

 Weight loss

1 (3)

 

0 (0)

 Abdominal distension

0 (0)

 

1 (4)

 Encephalopathy

0 (0)

1 (3)

0 (0)

 Nausea

0 (0)

1 (3)

0 (0)

 Hiccups

0 (0)

1 (3)

0 (0)

 Absence seizure

0 (0)

1 (3)

0 (0)

 Hydrocele testis

0 (0)

1 (3)

0 (0)

Hematological

 Thrombocytopenia

3 (9)

 

0 (0)

 Transaminase elevation

7 (21)

3 (9)

6 (26)

 Total bilirubin elevation

2 (6)

1 (3)

2 (9)

 Creatinine elevation

0 (0)

 

0 (0)

 Amylase elevation

1 (3)

 

0 (0)

 Lipase elevation

9 (27)

 

4 (17)

 Liver failure

1 (3)

 

0 (0)

 Hypoalbuminemia

0 (0)

 

1 (4)

 Hyponatremia

1 (3)

 

0 (0)

 Hypophosphatemia

2 (6)

 

0 (0)

Others

 Portal thrombosis

0 (0)

1 (3)

0 (0)

  1. HAIC hepatic arterial infusion chemotherapy