Table 3

SAEs with treatment discontinuation in the FCCam arm

EventsOccurrence
Mucormycosis After cycle 6 
Diffuse large B-cell lymphoma After cycles 4 and 5 
EBV-associated lymphoproliferative disorder After cycle 5 
Heart failure during neutropenia After cycle 2 
Septic shock (Pseudomonas aeruginosa) After end of evaluation 
Gastrointestinal stromal tumor After end of evaluation 
Ocular toxoplasmosis After cycle 6 
Pneumococcal sepsis After cycle 1 
Pneumonia/Clostridium difficile colitis After cycle 5 
Respiratory insufficiency After end of evaluation 
Subdural hematoma After cycle 1 
Tumor lysis syndrome After cycle 1 
EventsOccurrence
Mucormycosis After cycle 6 
Diffuse large B-cell lymphoma After cycles 4 and 5 
EBV-associated lymphoproliferative disorder After cycle 5 
Heart failure during neutropenia After cycle 2 
Septic shock (Pseudomonas aeruginosa) After end of evaluation 
Gastrointestinal stromal tumor After end of evaluation 
Ocular toxoplasmosis After cycle 6 
Pneumococcal sepsis After cycle 1 
Pneumonia/Clostridium difficile colitis After cycle 5 
Respiratory insufficiency After end of evaluation 
Subdural hematoma After cycle 1 
Tumor lysis syndrome After cycle 1 

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