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Revista Cubana de Hematología, Inmunología y Hemoterapia

On-line version ISSN 1561-2996

Abstract

GIL AGRAMONTE, Mildrey; YEAR ALOS, Isis Belkis  and  GONZALEZ OTERO, Alejandro. Adverse drug events during the induction treatment of acute lymphoblastic leukemia in children. Rev Cubana Hematol Inmunol Hemoter [online]. 2021, vol.37, n.3  Epub Sep 01, 2021. ISSN 1561-2996.

Introduction:

During the induction treatment of acute lymphoid leukemia in children, adverse drug reactions are not always identified.

Aims:

Describe the demographic and clinical characteristics of children with acute lymphoid leukemia who receive induction treatment at the Institute of Hematology and Immunology between 2012-2017. Characterize adverse events that occur during induction treatment. Describe adverse drug reactions during induction.

Methods:

Observational, descriptive, cross-sectional study of case series in pharmacovigilance, used active pharmacovigilance. Variables: sex, age, prognosis group, week of treatment, type of adverse event, organ system affected, severity and imputability. The information was obtained from the national register of the ALLIC-BFM 2009 protocol and the medical records.

Results:

69 children were included, 55.1% belonged to the male sex, 56.5% were between one and six years old. 52.2% (36 children) belonged to the intermediate prognosis group. 471 events were recorded. 50.5% occurred in the first week of treatment. The most frequent: anemia (17.8%), neutropenia (16.1%) and thrombocytopenia (15.9%). The most affected organ systems: hemolinfopoietic (57.5%) and gastrointestinal (15.7%). According to the severity, 72.4% were moderate and 27.4% severe.

Conclusions:

The whole presented adverse events, hematological alterations and reported events for drugs included in chemotherapy predominated. Adverse reactions classified as possible were identified, moderate and severe predominated

Keywords : pharmacovigilance; acute lymphoid leukemia; adverse reactions; hematology.

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