{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:20:43Z","timestamp":1786926043600,"version":"build-2736575974"},"reference-count":42,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2022,5,17]],"date-time":"2022-05-17T00:00:00Z","timestamp":1652745600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Austrian Group of Medical Tumor Therapy and Celgene"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background: Azacitidine is the treatment backbone for patients with acute myeloid leukemia, myelodysplastic syndromes and chronic myelomonocytic leukemia who are considered unfit for intensive chemotherapy. Detailed reports on adverse events in a real-world setting are lacking. Aims: To analyze the frequency of adverse events in the Austrian Registry of Hypomethylating agents. To compare real-world data with that of published randomized clinical trials. Results: A total of 1406 patients uniformly treated with a total of 13,780 cycles of azacitidine were analyzed. Hematologic adverse events were the most common adverse events (grade 3\u20134 anemia 43.4%, grade 3\u20134 thrombopenia 36.8%, grade 3\u20134 neutropenia 36.1%). Grade 3\u20134 anemia was significantly more common in the Registry compared to published trials. Febrile neutropenia occurred in 33.4% of patients and was also more common in the Registry than in published reports. Other commonly reported adverse events included fatigue (33.4%), pain (29.2%), pyrexia (23.5%), and injection site reactions (23.2%). Treatment termination due to an adverse event was rare (5.1%). Conclusion: The safety profile of azacitidine in clinical trials is reproducible in a real-world setting. With the use of prophylactic and concomitant medications, adverse events can be mitigated and azacitidine can be safely administered to almost all patients with few treatment discontinuations.<\/jats:p>","DOI":"10.3390\/cancers14102459","type":"journal-article","created":{"date-parts":[[2022,5,17]],"date-time":"2022-05-17T04:04:19Z","timestamp":1652760259000},"page":"2459","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Adverse Events in 1406 Patients Receiving 13,780 Cycles of Azacitidine within the Austrian Registry of Hypomethylating Agents\u2014A Prospective Cohort Study of the AGMT Study-Group"],"prefix":"10.3390","volume":"14","author":[{"given":"Michael","family":"Leisch","sequence":"first","affiliation":[{"name":"3rd Medical Department with Hematology, Medical Oncology, Rheumatology and Infectiology, Paracelsus Medical University, 5020 Salzburg, Austria"},{"name":"Salzburg Cancer Research Institute (SCRI) Center for Clinical Cancer and Immunology Trials (CCCIT), Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria"},{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Pfeilst\u00f6cker","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"3rd Medical Department for Haematology and Oncology, Hanusch Hospital, 1140 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8993-9561","authenticated-orcid":false,"given":"Reinhard","family":"Stauder","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"Department of Internal Medicine V, Innsbruck Medical University, 6020 Innsbruck, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8182-990X","authenticated-orcid":false,"given":"Sonja","family":"Heibl","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"4th Medical Department of Internal Medicine, Hematology, Internistic Oncology and Palliative Medicine, Klinikum Wels-Grieskirchen GmbH, 4600 Wels, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0993-4371","authenticated-orcid":false,"given":"Heinz","family":"Sill","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"Division of Hematology, Medical University of Graz, 8036 Graz, 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LKH Hochsteiermark, 8700 Leoben, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Hartmann","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"Department of Internal Medicine, Landeskrankenhaus Feldkirch, 6800 Feldkirch, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Petzer","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"Medical Oncology and Hematology, Internal Medicine I, Ordensklinikum Linz GmbH Barmherzige Schwestern, 4020 Linz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Schreder","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"1st Department of Internal Medicine, Center for 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Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigrid","family":"Machherndl-Spandl","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"1st Medical Department, Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz GmbH Elisabethinen, 4020 Linz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominik","family":"Wolf","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"Department of Internal Medicine V, Innsbruck Medical University, 6020 Innsbruck, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Keil","sequence":"additional","affiliation":[{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"},{"name":"3rd Medical Department for Haematology 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Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Pleyer","sequence":"additional","affiliation":[{"name":"3rd Medical Department with Hematology, Medical Oncology, Rheumatology and Infectiology, Paracelsus Medical University, 5020 Salzburg, Austria"},{"name":"Salzburg Cancer Research Institute (SCRI) Center for Clinical Cancer and Immunology Trials (CCCIT), Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria"},{"name":"Austrian Group of Medical Tumor Therapy (AGMT) Study Group, 1140 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,5,17]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2375","DOI":"10.1182\/blood-2016-01-643569","article-title":"The 2016 revision of the World Health Organization classification of lymphoid 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