Table 2.

Frequent and serious adverse events reported during treatment period


Event

Grade 1

Grade 2

Grades 3-4

Total, %
Allergic reaction*  5   5   0   50  
Injection site reaction  6   3   0   45  
Upper respiratory  7   1   0   40  
Headache   6   2   0   40  
Fatigue   2   4   0   30  
Pneumonia   0   0   2   10  
Confusion   0   0   1   5  
Back pain   0   0   1   5  
Sepsis
 
0
 
0
 
1
 
5
 

Event

Grade 1

Grade 2

Grades 3-4

Total, %
Allergic reaction*  5   5   0   50  
Injection site reaction  6   3   0   45  
Upper respiratory  7   1   0   40  
Headache   6   2   0   40  
Fatigue   2   4   0   30  
Pneumonia   0   0   2   10  
Confusion   0   0   1   5  
Back pain   0   0   1   5  
Sepsis
 
0
 
0
 
1
 
5
 

Values reflect events that occurred in more than 20% of patients and all grades 3-4 events. No grade 5 events were reported.

*

Includes hives, rhinitis, rigors, chills, and dyspnea.

Injection site reactions were dose-dependent.

Includes cough, congestion, infection.

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