Table 4.

Nonhematologic side effects



No. (%)
Side effect
Grade 1 or 2
Grade 3 or higher
Phase 1   
    Nausea/vomiting   11 (92)   —  
    Diarrhea   8 (67)   1 (8)* 
    Impaired liver function  8 (67)   —  
    Skin rash   6 (50)   1 (8)* 
    Mucositis   5 (42)   —  
    Facial flushing   5 (42)   —  
    Fatigue   3 (25)   —  
    Headaches   2 (17)   —  
    Palpitations/arrhythmias   1 (8)   —  
Phase 2   
    Impaired liver function  16 (80)   2 (10)  
    Nausea/vomiting   14 (70)   —  
    Skin rash   12 (60)   2 (10)  
    Diarrhea   10 (50)   4 (20)  
    Hand-foot syndrome   9 (45)   1 (5)  
    Mucositis   7 (35)   —  
    Headaches   7 (35)   —  
    Facial flushing   3 (15)   —  
    Fatigue   2 (10)   —  
    Palpitations/arrhythmias   1 (5)   1 (5)  
    Drug fever
 
1 (5)
 

 


No. (%)
Side effect
Grade 1 or 2
Grade 3 or higher
Phase 1   
    Nausea/vomiting   11 (92)   —  
    Diarrhea   8 (67)   1 (8)* 
    Impaired liver function  8 (67)   —  
    Skin rash   6 (50)   1 (8)* 
    Mucositis   5 (42)   —  
    Facial flushing   5 (42)   —  
    Fatigue   3 (25)   —  
    Headaches   2 (17)   —  
    Palpitations/arrhythmias   1 (8)   —  
Phase 2   
    Impaired liver function  16 (80)   2 (10)  
    Nausea/vomiting   14 (70)   —  
    Skin rash   12 (60)   2 (10)  
    Diarrhea   10 (50)   4 (20)  
    Hand-foot syndrome   9 (45)   1 (5)  
    Mucositis   7 (35)   —  
    Headaches   7 (35)   —  
    Facial flushing   3 (15)   —  
    Fatigue   2 (10)   —  
    Palpitations/arrhythmias   1 (5)   1 (5)  
    Drug fever
 
1 (5)
 

 

There were 12 patients in phase 1 and 20 patients in phase 2. — indicates that there were no grade 3 or higher toxicities.

*

Grade 3 toxicity occurred after 2-week observation period necessary to establish dose escalation.

Includes hyperbilirubinemia and elevation of transaminases.

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