Safety Analysis
In general, treatment modalities were both well tolerated. 88.3% in AZA group and 90.4% in CYC group completed six months induction therapy. Major side effects are shown in Table 3. In AZA group, 10 patients had side effects that resulted in treatment discontinuation in the first week of treatment . Four patients had severe nausea-vomiting, two patients abdominal pain/bloating, four patients had liver function abnormalities and one patient developed thrombocytopenia and neutropenia. In five patients, dosage reduction was needed in AZA, two due to elevated liver enzymes and three due to gastrointestinal complaints. In CYC group, cessation of therapy was not needed however, two patients had gastro-intestinal complaints, nause/ vomiting, five had frequent infections that resulted in hospitalization and led to 2 weeks delay in regular dosing, three patients had cytopenias and three patients had elevated liver enzymes, which resulted in decreases in bi-weekly dosages. No treatment related death occurred during the study period..