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Table 4 Most frequent treatment emergent adverse events (n = 57 patients)

From: Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment

Adverse Event

Grade 1

n (%)

Grade 2

n (%)

Grade 3

n (%)

Grade 4

n (%)

Total

n (%)

Fatigue

20 (35.1)

10 (17.5)

1 (1.8)

0

31 (54.4)

Headache

13 (22.8)

6 (10.5)

2 (3.5)

0

21 (36.8)

Seizure

2 (3.5)

10 (17.5)

7 (12.2)

0

19 (33.0)

Nausea

11 (19.3)

6 (10.5)

0

0

17 (29.8)

Focal weakness

3 (5.3)

8 (14.0)

5 (8.7)

0

16 (28.1)

Thrombocytopenia

5 (8.7)

4 (7.0)

2 (3.6)

2 (3.6)

13 (22.8)

Insomnia

8 (14)

4 (7.0)

0

0

12 (21.0)

Vomiting

7 (12.2)

4 (7.0)

0

0

11 (19.3)

Abdominal pain

8 (14.0)

2 (3.5)

1 (1.8)

0

11 (19.3)

Fall

6 (10.5)

1 (1.8)

1 (1.8)

2 (3.5)

10 (17.5)

Dizziness

8 (14.0)

2 (3.5)

0

0

10 (17.5)

Cerebral edema

0

1 (1.8)

6 (10.5)

2 (3.5)

9 (15.8)

Injection-site reaction

8 (14.0)

1 (1.8)

0

0

9 (15.8)

Myalgia

5 (8.7)

3 (5.3)

0

0

8 (14.0)

Depression

4 (7.0)

4 (7.0)

0

0

8 (14.0

Neutropenia

0

2 (3.5)

4 (7.0)

1 (1.8)

7 (12.2)

DVT/PE

0

3 (5.3)

4 (7.0)

0

7 (12.2)

Flu-like symptoms

6 (10.5)

1 (1.8)

0

0

7 (12.2)

Confused/Forgetful

2 (3.5)

3 (5.3)

1 (1.8)

0

6 (10.5)

Bone pain

6 (10.5)

0

0

0

6 (10.5)

Pruritis

6 (10.5)

0

0

0

6 (10.5)

  1. DVT/PE deep venous thrombosis and/or pulmonary embolus