Table 5

Summary of treatment withdrawals and number of O-FC courses completed

Number of courses received and reason for treatment withdrawalNo. of patients
Ofatumumab 500 mg (n = 31)Ofatumumab 1000 mg (n = 30)Total (N = 61)
Did not receive 6 courses of O-FC 13 22 
Received 3 or fewer courses of O-FC due to: 
    Cytopenias 
    AIHA  
    Nonresponse 
    Patient request  
    Myocardial infarction  
    Chest discomfort  
    Death  
Received 4-5 courses of O-FC due to:    
    Cytopenias 4* 5* 
    AIHA 
    Investigator decision  
    Patient request  
Number of courses received and reason for treatment withdrawalNo. of patients
Ofatumumab 500 mg (n = 31)Ofatumumab 1000 mg (n = 30)Total (N = 61)
Did not receive 6 courses of O-FC 13 22 
Received 3 or fewer courses of O-FC due to: 
    Cytopenias 
    AIHA  
    Nonresponse 
    Patient request  
    Myocardial infarction  
    Chest discomfort  
    Death  
Received 4-5 courses of O-FC due to:    
    Cytopenias 4* 5* 
    AIHA 
    Investigator decision  
    Patient request  

AIHA indicates autoimmune hemolytic anemia.

*

Two patients in the 1000-mg cohort received all 6 infusions of ofatumumab but no fludarabine and cyclophosphamide during treatment course 6 due to cytopenias.

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