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Table 2 Safety evaluation

From: A Phase I clinical trial of EUS-guided intratumoral injection of the oncolytic virus, HF10 for unresectable locally advanced pancreatic cancer

Patient no.

Toxicity of HF10

DLT

Evaluation (CTCAE ver 4.0)

Cohort 1

HF-1-02

(−)

(−)

Grade III Neutrophil and Platlet count decrease, Duodenal stenosis, Perforative peritonitis

HF-1-04

(−)

(−)

Grade II fever, Blood bilirubin increase (stent failure), Interstitial pneumonia (After treatment)

HF-1-05

(−)

(−)

NA

Cohort 2

HF-2-01

(−)

(−)

Grade III Neutrophil decrease

HF-2-02

(−)

(−)

Grade III Neutrophil decrease

HF-2-03

(−)

(−)

Grade III Neutrophil decrease and Grade II ALT increase

Cohort 3

HF-3-01

(−)

(−)

Grade IV Hepatobiliary disorder

HF-3-02

(−)

(−)

NA

HF-3-03

(−)

(−)

NA

HF-3-04

(−)

(−)

Grade III Neutrophil decrease

  1. DLT dose-limiting toxicity