Table 9

Nonserious related adverse events (AEs) reported during the study period, excluding decreased CD4+ T-cell counts

No. patients (no. events)
Grade 1Grade 2Grade 3
Skin and subcutaneous tissue disorders    
    Eczema and dermatitis 4 (4) 3 (3) 2 (2) 
    Urticaria 1 (1) 2 (2) 0 (0) 
    Pruritus 2 (2) 3 (3) 2 (2) 
    Other skin and subcutaneous tissue disorders 6 (6) 2 (2) 0 (0) 
General disorders and administration-site conditions    
    Fatigue 9 (11) 0 (0) 0 (0) 
    Flulike symptoms 4 (8) 3 (3) 1 (1) 
    Other general disorders and administration-site conditions 13 (25) 4 (4) 0 (0) 
Infections and infestations    
    Skin-related infections 3 (3) 2 (3) 0 (0) 
    Upper respiratory tract infections 1 (1) 0 (0) 0 (0) 
    Pneumonia 0 (0) 1 (1) 0 (0) 
    Oral candidiasis 0 (0) 1 (1) 0 (0) 
Other system organ classes    
    Muscle fiber rupture 0 (0) 0 (0) 1 (1) 
    Other 20 (48) 10 (13) 0 (0) 
No. patients (no. events)
Grade 1Grade 2Grade 3
Skin and subcutaneous tissue disorders    
    Eczema and dermatitis 4 (4) 3 (3) 2 (2) 
    Urticaria 1 (1) 2 (2) 0 (0) 
    Pruritus 2 (2) 3 (3) 2 (2) 
    Other skin and subcutaneous tissue disorders 6 (6) 2 (2) 0 (0) 
General disorders and administration-site conditions    
    Fatigue 9 (11) 0 (0) 0 (0) 
    Flulike symptoms 4 (8) 3 (3) 1 (1) 
    Other general disorders and administration-site conditions 13 (25) 4 (4) 0 (0) 
Infections and infestations    
    Skin-related infections 3 (3) 2 (3) 0 (0) 
    Upper respiratory tract infections 1 (1) 0 (0) 0 (0) 
    Pneumonia 0 (0) 1 (1) 0 (0) 
    Oral candidiasis 0 (0) 1 (1) 0 (0) 
Other system organ classes    
    Muscle fiber rupture 0 (0) 0 (0) 1 (1) 
    Other 20 (48) 10 (13) 0 (0) 

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