Evidence map›Paper›PMID 42026320›Full record

ArticleAnnals of hematology2026

Neutropenia and infectious events during off-label treatment with venetoclax in children with malignant disease: a pharmacovigilance analysis of FDA adverse event reporting system reports.

Edoardo Muratore, Valentina Giunchi, Michele Fusaroli, Francesco Baccelli, Francesca Gottardi, Elisabetta Poluzzi, Riccardo Masetti, Emanuel Raschi

Abstract read
In one paragraph

Article in Annals of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Edoardo MuratorePediatric Hematology and Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 40138, Italy.
Valentina GiunchiDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Michele FusaroliDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Francesco BaccelliPediatric Hematology and Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 40138, Italy. francesco.baccelli3@unibo.it.
Francesca GottardiPediatric Hematology and Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 40138, Italy.
Elisabetta PoluzziDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Riccardo MasettiPediatric Hematology and Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 40138, Italy.
Emanuel RaschiDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Venetoclax, a BCL-2 inhibitor, is increasingly used off-label in pediatric malignancies, but safety data remain limited. This pharmacovigilance study analyzed 488 pediatric reports from the FDA Adverse Event Reporting System (FAERS) involving neutropenia and infection with venetoclax use. Disproportionately reported events included sepsis, leukopenia/agranulocytosis, and pseudomembranous colitis. Most cases involved acute myeloid leukemia or myelodysplastic syndromes and combination therapy. Network analysis revealed co-reporting of hematologic and infectious toxicities. These findings emphasize the need for vigilant monitoring and dedicated pediatric studies to guide venetoclax use and improve supportive care strategies in this vulnerable population receiving intensive or multimodal treatments.

Indexed as

Adverse Drug Reaction Reporting SystemsAntineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicNeutropeniaOff-Label UsePharmacovigilanceSulfonamidesAdolescentChildChild, PreschoolFemaleHumansInfantLeukemia, Myeloid, AcuteMaleMyelodysplastic SyndromesAntineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicSulfonamidesvenetoclaxAcute leukemiaChildrenPediatric hematologyPharmacovigilanceVenetoclax

Identifiers

PMID42026320
PMCPMC13106237

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.