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..