Table 1.

Adverse effects beyond 56 weeks of study treatment: grade 3 or higher events and SAEs

Event, grade ≥3Event frequency (N = 17) (%)
Neutropenia 1 (6) 
Hypertension 1 (6) 
Cutaneous neoplasm 1 (6) 
Therapy-related myelodysplastic syndrome 1 (6)  
Glioblastoma multiforme 1 (6) 
Metastatic small cell lung cancer 1 (6) 
Febrile neutropenia 1 (6)  
Sinusitis 1 (6)  
Urosepsis 1 (6)  
Infectious enterocolitis 1 (6)  
Lung infection 2 (12)  
Diarrhea 3 (17)  
Event, grade ≥3Event frequency (N = 17) (%)
Neutropenia 1 (6) 
Hypertension 1 (6) 
Cutaneous neoplasm 1 (6) 
Therapy-related myelodysplastic syndrome 1 (6)  
Glioblastoma multiforme 1 (6) 
Metastatic small cell lung cancer 1 (6) 
Febrile neutropenia 1 (6)  
Sinusitis 1 (6)  
Urosepsis 1 (6)  
Infectious enterocolitis 1 (6)  
Lung infection 2 (12)  
Diarrhea 3 (17)  

SAEs, serious adverse events.

These events were SAEs.

Two of the events were SAEs.

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