Extension study, pilot, single-arm, compassionate use of Hikma Azacitidine 300 mg Film coated tablets test product for the Acute Myeloid Leukaemia (AML) patients who completed Hikma bioequivalence study with protocol number: HIK-AZA-2023-01
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
300 mg Film coated tablets
Sheikh Shakhbout Medical City
Abu Dhabi, United Arab Emirates
Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug
Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug
Time frame: Up to 12 months
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