Evidence map›Paper›PMID 25580915›Full record

ArticleAmerican journal of hematology2015

Cardiovascular and pulmonary adverse events in patients treated with BCR-ABL inhibitors: Data from the FDA Adverse Event Reporting System.

Jorge Cortes, Michael Mauro, Juan Luis Steegmann, Giuseppe Saglio, Rachpal Malhotra, Jon A Ukropec, Nicola T Wallis

Open access · greenAbstract read
In one paragraph

Article in American journal of hematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
6.5field-weighted citation impact, top 3% 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

28 citing papers in PubMed, 61 citations in OpenAlex.

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  6. Drug-induced pulmonary edema: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS).Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2025
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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 6 institutions in 4 countries.

Jorge CortesDepartment of Leukemia, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas.
Michael Mauro
Juan Luis Steegmann
Giuseppe Saglio
Rachpal Malhotra
Jon A Ukropec
Nicola T Wallis
Bristol-Myers Squibb (United States) · USBristol-Myers Squibb (Germany) · DEHospital Universitario de La Princesa · ESMemorial Sloan Kettering Cancer Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of Turin · IT

Funding

TOLERANCE INDUCTION BY MEGADOSE STEM CELL TRANSPLANTS IN CML--GVHD AND GVLP01CA049639 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THALL, PETER F · 1990 to 2014
$41.8M
NCI NIH HHS P01 CA049639
6 · The paper itself

Abstract

Rare but serious cardiovascular and pulmonary adverse events (AEs) have been reported in patients with chronic myeloid leukemia treated with BCR-ABL inhibitors. Clinical trial data may not reflect the full AE profile of BCR-ABL inhibitors because of stringent study entry criteria, relatively small sample size, and limited duration of follow-up. To determine the utility of the FDA AE Reporting System (FAERS) surveillance database for identifying AEs possibly associated with the BCR-ABL inhibitors imatinib, dasatinib, and nilotinib in the postmarketing patient population, we conducted Multi-Item Gamma Poisson Shrinker disproportionality analyses of FAERS reports on AEs in relevant system organ classes. Signals consistent with the known safety profiles of these agents as well as signals for less well-described AEs were detected. Bone marrow necrosis, conjunctival hemorrhage, and peritoneal fluid retention events were uniquely associated with imatinib. AEs that most commonly reached the threshold for dasatinib consisted of terms relating to hemorrhage and fluid retention, including pleural effusion and pericardial effusion. Most terms that reached the threshold solely with nilotinib were related to peripheral and cardiac vascular events. Although this type of analysis cannot determine AE incidence or establish causality, these findings elucidate the AEs reported in patients treated with BCR-ABL inhibitors across multiple clinical trials and in the community setting for all approved and nonapproved indications, suggesting drug-AE associations warrant further investigation. These findings emphasize the need to consider patient comorbidities when selecting amongst BCR-ABL inhibitors.

Indexed as

AdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAntineoplastic AgentsBenzamidesCardiovascular DiseasesDasatinibDatabases, FactualFusion Proteins, bcr-ablHumansImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLogistic ModelsLung DiseasesMiddle AgedAntineoplastic AgentsBenzamidesDasatinibFusion Proteins, bcr-ablImatinib MesylatenilotinibPiperazinesPyrimidinesThiazoles

Identifiers

PMID25580915
PMCPMC11458256
OpenAlexW1495300968

What OpenQuestion holds

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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.