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Table 2 Adverse events related to vaccine and IL-2

From: Phase II trial of Modified Vaccinia Ankara (MVA) virus expressing 5T4 and high dose Interleukin-2 (IL-2) in patients with metastatic renal cell carcinoma

Vaccine-related AEs

Maximum Grade

Patients

System

Adverse Events

 

N = 25

%

Constitutional

Fever

1

8

32

 

Pain at injection site

1

4

16

 

Injection site reaction

1

3

12

 

Myalgia

1

1

4

 

Chills

1

1

4

IL-2-related AEs

   

Cardiovascular

Cardiopulmonary arrest

4

1

4

 

Elevated troponin

4

1

4

 

Hypotension

4

9

36

 

Ventricular tachycardia

3

1

4

 

Acidosis

4

1

4

Electrolyte

Hyperglycemia

3

4

16

 

Hypocalcemia

3

1

4

 

Hyponatremia

3

11

44

 

Hypophosphatemia

3

3

12

Gastro-intestinal

Ischemic bowel

4

1

4

Hematologic

Anemia

3

2

8

 

Neutropenia

3

1

4

 

Thrombocytopenia

3

4

16

Hepatic

Elevated transaminases

3

1

4

 

Hyperbilirubinemia

3

3

12

Neurologic

Confusion

3

3

12

 

Syncope

3

2

8

Pulmonary

Dyspnea

3

1

4

Renal

Elevated creatinine

3

22

88

 

Oliguria

3

2

8

Systemic

Fatigue

3

1

4