Table 4

Adverse events reported in the rituximab and placebo groups

RituximabPlacebo
Serious adverse events* 2 1 
Infusion reactions† 20 10 
Musculoskeletal pain 9 2 
Upper respiratory tract infection 7 7 
Fatigue 7 2 
Cough 4 3 
Nasal congestion 4 1 
Headache 2 3 
Nausea, vomiting 0 4 
Other‡ 21 20 
    Total adverse events reported 76 53 
RituximabPlacebo
Serious adverse events* 2 1 
Infusion reactions† 20 10 
Musculoskeletal pain 9 2 
Upper respiratory tract infection 7 7 
Fatigue 7 2 
Cough 4 3 
Nasal congestion 4 1 
Headache 2 3 
Nausea, vomiting 0 4 
Other‡ 21 20 
    Total adverse events reported 76 53 
*

Two serious adverse events in the rituximab group were serum sickness and accidental fall; and 1 serious adverse event in the placebo group was adrenal hemorrhage.

†

Infusion reactions were adverse events that were temporally related to study drug infusions.

‡

Occurred in < 5% of patients.

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