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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