Table 4.

Summary of grade 3, 4, and 5 AEs

AEAzacitidine arm*Observation arm
Any grade (no. of events), n = 302Grade 3-5 (no. of events)Any grade (no. of events, n = 215Grade 3-5 (no. of events)
Hematologic 143 58 
 Thrombocytopenia 119 29 
 Poor graft function 33 29 
Nonhematologic 159 33 210 56 
 Infection 42 13 52 19 
 Gastrointestinal 41 44 12 
 Hepatic 17 19 
 Pulmonary 
 Skin 27 32 
AEAzacitidine arm*Observation arm
Any grade (no. of events), n = 302Grade 3-5 (no. of events)Any grade (no. of events, n = 215Grade 3-5 (no. of events)
Hematologic 143 58 
 Thrombocytopenia 119 29 
 Poor graft function 33 29 
Nonhematologic 159 33 210 56 
 Infection 42 13 52 19 
 Gastrointestinal 41 44 12 
 Hepatic 17 19 
 Pulmonary 
 Skin 27 32 
*

There were 325 any grade AEs in the azacitidine arm, but 302 were related to the azacitidine intervention.

There was no grade 5 hematologic toxicity in the azacitidine arm. There was only one grade 5 toxicity, which was pulmonary and associated with aspiration pneumonia.

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