OBJECTIVE To excavate and evaluate the post-marketing adverse reaction signals of three domestic targeted therapeutic drugs for acute myeloid leukemia.
METHODS Using the OpenVigil data platform, post-marketing adverse drug reaction(ADR) reports for venetoclax, gilteritinib, and ivosidenib from the US FDA Adverse Event Reporting System was obtained. The proportional reporting ratio method and reporting odds ratio method were used to detect ADR signals for venetoclax, gilteritinib, and ivosidenib, and the signals were sorted according to their occurrence frequency and signal strength, respectively.
RESULTS A total of 14 193 ADR reports were collected for venetoclax with 219 ADR signals; 1 885 ADR reports were collected for gilteritinib with 125 ADR signals; and 699 ADR reports were collected for ivosidenib with 41 ADR signals. Based on the basic information of the ADR reports, the patient population for all three drugs had a higher male-to-female ratio, and the age distribution of the patients was concentrated mainly between 60 and 74 years old. The most frequent ADRs for venetoclax, gilteritinib, and ivosidenib were "death" "decreased platelet count" and "fatigue" respectively. The ADRs with the highest signal strength were "FLT3 gene mutation" "increased blast cell count" and "differentiation syndrome" respectively. The top 20 ADR signals for the three drugs involved a total of 10 system organs, including various tests, blood and lymphatic system diseases, infectious and infectious diseases, etc. For venetoclax and gilteritinib, the system organ with the highest proportion of the top 20 ADRs by frequency was "blood and lymphatic system diseases". For ivosidenib, the system organ with the highest proportion of the top 20 ADRs by frequency was "various tests".
CONCLUSION It is recommended that clinical attention should be paid to ADRs such as atrial fibrillation caused by venetoclax and sepsis caused by gilteritinib.
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