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Table 2 Safety and tolerability of balixafortide. Summary of adverse events

From: Mobilization of hematopoietic stem cells with the novel CXCR4 antagonist POL6326 (balixafortide) in healthy volunteers—results of a dose escalation trial

Dose (μg/kg)

500

1000

1000

1500

2000

2000

2500

Infusion time/rate

2 h./const.

2 h./const.

1 h./const.

2 h./const.

2 h./const.

2 h./ramp

2 h./const.

n Volunteers

3

7

3

7

6

3

10

Volunteers with AE

1

5

1

2

6

2

7

Erythema

   

1

4

 

7

Pruritus

 

2

1

1

4

2

 

Infusion site erythema

1

  

2

   

Infusion site pruritus

 

1

 

1

   

Urticaria

   

1

1

  

Flushing

    

1

1

 

Hypoasthesia oral

      

2

BP increase

 

2

     

Blood CK increased

    

2

  

Infusion site irritation

   

1

   

Feeling hot

      

1

Muscle tightness

      

1

Headache

      

1

Hypoasthesia

    

1

 

Throat tightness

      

1

Bone pain

    

1

  

Vertigo

      

 1

  1. A total of 27 volunteers were treated with 39 doses of balixafortide. Therefore some volunteers (12) were included in two different groups, when adverse events per dose-group were assessed. Responses to all items were binary (yes/no), not quantitative; multiple responses were possible