Table 6.

Adverse events

Control,*n = 160
HDC + IL-2,*n = 157
Grades 1 and 2
Grade 3
Grade 4
Grades 1 and 2
Grade 3
Grade 4
P†
Blood        
Thrombocytopenia   13.8   9.4   0   13   16   1.3   .16  
Eosinophilia   0   0   0   18   1.9   0   <.001  
Neutropenia   5.0   3.1   0   6.4   5.7   0   .27  
Leukopenia NOS   11   1.9   0   7.0   0.6   0.6   .20  
Anemia   5.0   0.6   0   5.7   1.3   0   >.5  
Cardiac        
Tachycardia NOS   1.3   0   0   14   0   0   <.001  
Palpitations   1.9   0   0   8.3   0   0   .01  
Gastrointestinal        
Nausea   9.4   0   0   31   1.3   0   <.001  
Dyspepsia   3.8   0   0   15   0.6   0   <.001  
Vomiting   5   0   0   15   0.6   0   .003  
Diarrhea   10   0   0   18   1.9   0   .02  
Abdominal pain   3.8   0   0   6.4   0   0   .32  
General        
Fatigue   16   1.3   0   42   1.3   0   <.001  
Pyrexia   16   1.3   0   41   2.5   0   <.001  
Pain NOS   2.5   0   0   7.7   0   0   .04  
Weakness   6.9   0   0   7.6   0   0   >.5  
Chest pain   5.7   0.6   0   8.9   0   0   .40  
Injection sites        
Erythema   NA   NA   NA   38   0   0   NA  
Granuloma   NA   NA   NA   44   0   0   NA  
Rigors   NA   NA   NA   18   0   0   NA  
Pruritus   NA   NA   NA   22   0.6   0   NA  
Infections        
Upper respiratory   14   0   0   18   0   0   .36  
Sinusitis   5.7   0   0   5.8   0   0   >.5  
Metabolic and nutrition        
Anorexia   3.1   0   0   8.3   0.6   0   .03  
Musculoskeletal        
Myalgia   1.9   0   0   19   0   0   <.001  
Arthralgia   14   0   0   23   1.3   0   .02  
Back pain   12   0   0   13   0.6   0   >.5  
Pain in limb   6.9   0   0   12   0   0   .13  
Nervous system        
Headache   14   0   0   51   7   0   <.001  
Dizziness   8.8   0   0   23   0.6   0   <.001  
Dysgeusia   0   0   0   13   1.3   0   <.001  
Psychiatric        
Insomnia   6.2   0   0   7.0   0.6   0   >.5  
Depression   3.1   0.6   0   7.7   0.6   0   .10  
Anxiety   8.8   0.6   0   5.1   0   0   .19  
Respiratory        
Cough   14   0   0   27   0.6   0   .003  
Pharyngitis   15   0   0   15   0.6   0   >.5  
Nasal congestion   1.3   0   0   12   0   0   <.001  
Dyspnea NOS   3.2   0   0   16   0.6   0   <.001  
Rhinitis   1.9   0   0   5.7   0   0   .08  
Rhinorrhea   2.5   0   0   6.3   0   0   .11  
Epistaxis   2.5   0   0   5.7   0   0   .17  
Sinus congestion   0.6   0   0   5.8   0   0   .01  
Skin        
Rash NOS   4.4   0   0   12   0.6   0   .01  
Sweating   1.3   0   0   9.5   0   0   <.001  
Urticaria   0   0   0   5.1   0   0   .003  
Vascular        
Flushing   0   0   0   87   1.3   0   <.001  
Hypotension NOS
 		 2.5
 		 0
 		 0
 		 13
 		 0
 		 0
 		 <.001
 
Control,*n = 160
HDC + IL-2,*n = 157
Grades 1 and 2
Grade 3
Grade 4
Grades 1 and 2
Grade 3
Grade 4
P†
Blood        
Thrombocytopenia   13.8   9.4   0   13   16   1.3   .16  
Eosinophilia   0   0   0   18   1.9   0   <.001  
Neutropenia   5.0   3.1   0   6.4   5.7   0   .27  
Leukopenia NOS   11   1.9   0   7.0   0.6   0.6   .20  
Anemia   5.0   0.6   0   5.7   1.3   0   >.5  
Cardiac        
Tachycardia NOS   1.3   0   0   14   0   0   <.001  
Palpitations   1.9   0   0   8.3   0   0   .01  
Gastrointestinal        
Nausea   9.4   0   0   31   1.3   0   <.001  
Dyspepsia   3.8   0   0   15   0.6   0   <.001  
Vomiting   5   0   0   15   0.6   0   .003  
Diarrhea   10   0   0   18   1.9   0   .02  
Abdominal pain   3.8   0   0   6.4   0   0   .32  
General        
Fatigue   16   1.3   0   42   1.3   0   <.001  
Pyrexia   16   1.3   0   41   2.5   0   <.001  
Pain NOS   2.5   0   0   7.7   0   0   .04  
Weakness   6.9   0   0   7.6   0   0   >.5  
Chest pain   5.7   0.6   0   8.9   0   0   .40  
Injection sites        
Erythema   NA   NA   NA   38   0   0   NA  
Granuloma   NA   NA   NA   44   0   0   NA  
Rigors   NA   NA   NA   18   0   0   NA  
Pruritus   NA   NA   NA   22   0.6   0   NA  
Infections        
Upper respiratory   14   0   0   18   0   0   .36  
Sinusitis   5.7   0   0   5.8   0   0   >.5  
Metabolic and nutrition        
Anorexia   3.1   0   0   8.3   0.6   0   .03  
Musculoskeletal        
Myalgia   1.9   0   0   19   0   0   <.001  
Arthralgia   14   0   0   23   1.3   0   .02  
Back pain   12   0   0   13   0.6   0   >.5  
Pain in limb   6.9   0   0   12   0   0   .13  
Nervous system        
Headache   14   0   0   51   7   0   <.001  
Dizziness   8.8   0   0   23   0.6   0   <.001  
Dysgeusia   0   0   0   13   1.3   0   <.001  
Psychiatric        
Insomnia   6.2   0   0   7.0   0.6   0   >.5  
Depression   3.1   0.6   0   7.7   0.6   0   .10  
Anxiety   8.8   0.6   0   5.1   0   0   .19  
Respiratory        
Cough   14   0   0   27   0.6   0   .003  
Pharyngitis   15   0   0   15   0.6   0   >.5  
Nasal congestion   1.3   0   0   12   0   0   <.001  
Dyspnea NOS   3.2   0   0   16   0.6   0   <.001  
Rhinitis   1.9   0   0   5.7   0   0   .08  
Rhinorrhea   2.5   0   0   6.3   0   0   .11  
Epistaxis   2.5   0   0   5.7   0   0   .17  
Sinus congestion   0.6   0   0   5.8   0   0   .01  
Skin        
Rash NOS   4.4   0   0   12   0.6   0   .01  
Sweating   1.3   0   0   9.5   0   0   <.001  
Urticaria   0   0   0   5.1   0   0   .003  
Vascular        
Flushing   0   0   0   87   1.3   0   <.001  
Hypotension NOS
 		 2.5
 		 0
 		 0
 		 13
 		 0
 		 0
 		 <.001
 

NOS indicates not otherwise specified; NA, not applicable.

*

Data are presented as the percentage of the safety population reported by at least 5% of patients in any of the control or HDC/IL-2 arms.

†

Statistical analysis using Fisher exact test.

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