Evidence map›Paper›PMID 26493604›Full record

ArticleThrombosis research2015

Severe hepatic dysfunction is associated with venous thromboembolic events in phase 1 clinical trials.

A S Mansfield, A J Tafur, D Vulih, G L Smith, P J Harris, S P Ivy

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Thrombosis research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 41% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

6 authors at 4 institutions in 1 country.

A S MansfieldDivision of Medical Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: mansfield.aaron@mayo.edu.
A J TafurVascular Medicine, Northshore University Health System, 2650 Ridge Avenue, Evanston, IL 60201, USA. Electronic address: atafur@northshore.org.
D VulihTheradex, 4365 Route 1 South, Princeton, NJ 08540, USA. Electronic address: DVulih@theradex.com.
G L SmithClinical Trials Monitoring Branch, Cancer Therapy Evaluation Program, National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD 20892, USA. Electronic address: SmithG@ctep.nci.nih.gov.
P J HarrisInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD 20892, USA. Electronic address: harrispj@mail.nih.gov.
S P IvyInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD 20892, USA. Electronic address: ivyp@ctep.nci.nih.gov.
National Cancer Institute · USMayo Clinic · USNorthShore University HealthSystem · USTheradex Oncology (United States) · US

Funding

Paul Calabresi Program in Clinical/Translational Research at Mayo ClinicK12CA090628 · NCI · MAYO CLINIC ROCHESTER · PI WEROHA, SARAVUT · 2001 to 2025
$19.7M
NCI NIH HHS K12 CA090628NCI NIH HHS K12CA090628
6 · The paper itself

Abstract

introductionVenous thromboembolic events (VTEs) are a significant cause of death in patients with cancer. The incidence of VTE is not well characterized in early phase clinical trials of novel antineoplastic agents, or in hepatic dysfunction studies designed for patients with varying degrees of liver test abnormalities. We compared the incidences of VTE in phase 1 clinical trials (P1CTs) and hepatic dysfunction trials (HDCTs) sponsored by the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI) of the United States. MATERIALS &

methodsWe reviewed individual patient records of 1841 subjects for symptomatic VTE diagnosed while on study: 1328 subjects on 42 P1CTs, and 513 subjects on 9 HDCTs. The NCI's Organ Dysfunction Working Group definitions were used to categorize patients. The incidences of VTEs between patients were compared by the Chi square test. Confounders were evaluated with the Cochran-Mantel-Haenszel method. RESULTS &

conclusionsThere were 43 VTEs identified among all subjects (2.3%). There were significantly more VTE observed in the subjects on P1CTs (n=38, 2.9%) than in the subjects on HDCTs (n=5, 1.0%; RR 0.341, 95% 0.13-0.86, p=0.015). For patients on HDCTs, those with severe dysfunction had a high incidence of VTE (RR 10.5 (1.12-93.6), p=0.021) that remained significant in a multivariate model. VTEs were observed less frequently in patients who were enrolled in HDCT than those who were enrolled in P1CT; however, patients with severe hepatic dysfunction were more likely to experience VTE. Severe liver test abnormalities may not be protective against VTE in patients with malignancies receiving chemotherapy.

Indexed as

AgedClinical Trials, Phase I as TopicFemaleHumansLiver DiseasesMaleMiddle AgedNeoplasmsVenous ThromboembolismClinical trials, phase 1Liver diseasesNeoplasmsPulmonary embolismVenous thrombosis

Identifiers

PMID26493604
PMCPMC4679432
OpenAlexW1815255911

What OpenQuestion holds

Textmetadata
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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.