Table 6.

Adverse events of at least grade 3 intensity occurring in patients at the recommended dose level of bortezomib and PegLD


Cycle no. (n)*

Adverse event (n)
1 (16)   Detailed in the section, “Adverse events”  
2 (10)   Allergic reaction (1), hypertension (1), hyponatremia (1), neutropenia (1), pneumonia (1), lymphopenia (2), thrombocytopenia (4)  
3 (10)   Hypertension (1), hyponatremia (1), peripheral neuropathy/impotence (1), pneumonia (1), lymphopenia (5), thrombocytopenia (5)  
4 (9)  Clostridium difficile infection (1), confusion (1), diarrhea (1), hypertension (1), sinusitis (1), vein thrombosis (1), peripheral neuropathy (2), thrombocytopenia (4), lymphopenia (5)  
5 (6)   Diarrhea (1), fever (1), thrombocytopenia (2), lymphopenia (3)  
6 (6)   Anorexia (1), thrombocytopenia (1), fatigue (1), lymphopenia (3)  
7 (3)   Diarrhea (1), lymphopenia (1)  
8 (2)
 
Lymphopenia (2)
 

Cycle no. (n)*

Adverse event (n)
1 (16)   Detailed in the section, “Adverse events”  
2 (10)   Allergic reaction (1), hypertension (1), hyponatremia (1), neutropenia (1), pneumonia (1), lymphopenia (2), thrombocytopenia (4)  
3 (10)   Hypertension (1), hyponatremia (1), peripheral neuropathy/impotence (1), pneumonia (1), lymphopenia (5), thrombocytopenia (5)  
4 (9)  Clostridium difficile infection (1), confusion (1), diarrhea (1), hypertension (1), sinusitis (1), vein thrombosis (1), peripheral neuropathy (2), thrombocytopenia (4), lymphopenia (5)  
5 (6)   Diarrhea (1), fever (1), thrombocytopenia (2), lymphopenia (3)  
6 (6)   Anorexia (1), thrombocytopenia (1), fatigue (1), lymphopenia (3)  
7 (3)   Diarrhea (1), lymphopenia (1)  
8 (2)
 
Lymphopenia (2)
 
*

Number of patients treated who were at risk for an adverse event.

Number of patients treated who developed the indicated event.

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