Table 2 Overall summary of GT-30 TRAEs

From: Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial

TRAEsa (n = 27/36)

Grade 1/2

Injection-site reactions

 

  Pain, erythema, pruritus or swelling

15 (41.6%)

Gastrointestinal

 

  Gastroesophageal reflux

2 (5.6%)

  Diarrhea

1 (2.8%)

  Abdominal pain (upper)

1 (2.8%)

  Nausea

1 (2.8%)

  Dry mouth

1 (2.8%)

Skin

 

  Rash

4 (11.1%)

  Pruritus

2 (5.6%)

  Dermatitis

1 (2.8%)

  Alopecia

1 (2.8%)

  Skin disorder

1 (2.8%)

  Dry skin

1 (2.8%)

Endocrine

 

  Hypothyroidism

2 (5.6%)

Musculoskeletal

 

  Pain in extremities, musculoskeletal pain or stiffness

3 (8.3%)

  Arthralgia

1 (2.8%)

Metabolism

 

  Decreased appetite

2 (5.6%)

  Hypophosphatemia

1 (2.8%)

  Polydipsia

1 (2.8%)

General

 

  Fatigue

4 (11.1%)

  Pyrexia

1 (2.8%)

  Chills

1 (2.8%)

  Anemia

1 (2.8%)

  Dysesthesia

1 (2.8%)

  Lethargy

1 (2.8%)

  Somnolence

1 (2.8%)

  Infusion-related reaction

1 (2.8%)

  Chest discomfort

1 (2.8%)

  Hepatitis

1 (2.8%)

  Elevated liver function test results

1 (2.8%)

Immune-related

 

  Immune-mediated nephritis

1 (2.8%)

  Pneumonitis

1 (2.8%)

  ICI hepatitis

1 (2.8%)

Use of systemic steroids

7 (19.4%)

  1. aTRAEs were determined by the investigator for those events deemed as possibly, probably or definitely related to the PTCV, IL-12, electroporation and/or ICI.