Evidence map›Paper›PMID 23460018›Full record

ArticleInternational journal of hematology2013

Incidence of sinusoidal obstruction syndrome following Mylotarg (gemtuzumab ozogamicin): a prospective observational study of 482 patients in routine clinical practice.

Martin S Tallman, George B McDonald, Laurie D DeLeve, Maria R Baer, Michael N Cook, G Jay Graepel, Carl Kollmer

Abstract read
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In one paragraph

Article in International journal of hematology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
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

13 citing papers in PubMed, 40 citations in OpenAlex.

  1. Trial
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  11. Defibrotide in the treatment of hepatic veno-occlusive disease.Hepatic medicine : evidence and research · 2016
    Review
  12. Sinusoidal obstruction syndrome (hepatic veno-occlusive disease).Journal of clinical and experimental hepatology · 2014
    Review
  13. Article
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

7 authors at 5 institutions in 1 country.

Martin S TallmanMemorial Sloan Kettering Cancer Center, Weill Cornell Medical College, 1275 York Ave.,New York, NY 10065, USA. tallmanm@mskcc.org
George B McDonald
Laurie D DeLeve
Maria R Baer
Michael N Cook
G Jay Graepel
Carl Kollmer
Pfizer (United States) · USCornell University · USFred Hutch Cancer Center · USUniversity of Maryland, Baltimore · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this prospective observational study was to determine the incidence of hepatic sinusoidal obstruction syndrome (SOS), following gemtuzumab ozogamicin (GO) therapy in routine clinical practice. Patients receiving GO for acute myeloid leukemia (AML) were eligible. Assessments were requested to be performed weekly for 6 weeks after the start of GO therapy or 4 weeks after the last dose (whichever was later), and after 6 months. The primary outcome variable was the incidence of SOS as judged by a panel of independent experts. A total of 512 patients were enrolled at 54 US centers and 482 were evaluable. The incidence of SOS in this study population was 9.1 % (44/482; 95 % confidence interval 6.9-12.0 %). Of the 44 patients classified as having SOS, 8 were mild, 17 moderate, and 19 severe; 33 died within 6 months (20 of disease progression and 13 of SOS and multiorgan failure). Most (68 %) patients in the study died within 6 months; most of these deaths (73 %) were due to progression of AML. Serious adverse events occurred in 85 % of patients, most (81 %) due to AML, febrile neutropenia, pyrexia, and sepsis. GO administered in routine clinical practice carries an overall 9.1 % risk of SOS and a 2.7 % risk of death from SOS and multiorgan failure. No risk factors were identified for the development of SOS.

Indexed as

AdultAgedAminoglycosidesAntibodies, Monoclonal, HumanizedAntineoplastic AgentsFemaleGemtuzumabHepatic Veno-Occlusive DiseaseHumansIncidenceLeukemia, Myeloid, AcuteMaleMiddle AgedMortalityProspective StudiesRisk FactorsAminoglycosidesAntibodies, Monoclonal, HumanizedAntineoplastic AgentsGemtuzumab

Identifiers

PMID23460018
OpenAlexW2011280229

What OpenQuestion holds

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Registered trials

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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.