Evidence map›Paper›PMID 29788694›Full record

Trial reportThe Korean journal of internal medicine2019

Long-term rivaroxaban for the treatment of acute venous thromboembolism in patients with active cancer in a prospective multicenter trial.

Ho-Young Yhim, Won-Il Choi, Sung-Hyun Kim, Seung-Hyun Nam, Kyoung Ha Kim, Yeung-Chul Mun, Doyeun Oh, Hun-Gyu Hwang, Keun-Wook Lee, Eun-Kee Song and 2 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Korean journal of internal medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01989845 (Prospective, Multicenter Study Investigating Efficacy and Safety of Oral Rivaroxaban for the Prevention of Recurrent Venous Thromboembolism in Korean Patients With Cancers), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT01989845 phase4completednot on this map

Prospective, Multicenter Study Investigating Efficacy and Safety of Oral Rivaroxaban for the Prevention of Recurrent Venous Thromboembolism in Korean Patients With Cancers

TypeinterventionalSponsorSeoul National University HospitalRan2013 to 2016Enrolled127ConditionsRivaroxaban, Cancer-associated Thrombosis, Recurrence, BleedingArmsRivaroxaban
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
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

12 authors.

Ho-Young YhimDepartment of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
Won-Il ChoiDepartment of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea.
Sung-Hyun KimDepartment of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
Seung-Hyun NamDepartment of Internal Medicine, Veterans Health Service Medical Center, Seoul, Korea.
Kyoung Ha KimDepartment of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.
Yeung-Chul MunDepartment of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
Doyeun OhDepartment of Internal Medicine, CHA University School of Medicine, Seongnam, Korea.
Hun-Gyu HwangDepartment of Internal Medicine, Soonchunhyang University Gumi Hospital, Gumi, Korea.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Eun-Kee SongDepartment of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
Yong Shik KwonDepartment of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea.
Soo-Mee BangDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.

Funding

Bayer Korea
6 · The paper itself

Abstract

BACKGROUND/

aimsLimited data are available regarding the efficacy of rivaroxaban for the treatment of cancer-associated venous thromboembolism (VTE). The aim of this study was to evaluate the effectiveness and safety of rivaroxaban for the treatment of VTE in active cancer patients.

methodsIn this prospective, multicenter, open-label trial (NCT01989845), we enrolled patients with active cancer and objectively diagnosed lower-extremity deep vein thrombosis, pulmonary embolism (PE), or both from November 2013 to June 2016. Active cancer was defined as a histologically confirmed malignancy, which was diagnosed or treated within the previous 6 months, or as a recurrent/ metastatic cancer. Patients received oral rivaroxaban 15 mg twice daily for first 3 weeks, followed by 20 mg once daily for 6 months. The primary outcome was the symptomatic recurrent VTE and the secondary outcomes included any recurrent VTE, major or clinically relevant non-major (CRNM) bleeding events, and overall mortality. All study outcomes were validated by blinded central adjudication.

resultsOf 124 patients enrolled, 110 (88.7%) had solid cancer, 93 (75.0%) had metastatic disease, and 110 (88.7%) were receiving chemotherapy or radiotherapy. During the 6-month study period, seven patients experienced symptomatic recurrent VTE (cumulative incidence, 5.9%), and two patients experienced incidental recurrent PE (cumulative incidence of any recurrent VTE, 7.6%). Major bleeding events occurred in six patients (cumulative incidence, 5.3%) and CRNM bleeding events in 11 patients (cumulative incidence, 10.2%). Twenty-eight patients (overall mortality, 24.0%) died.

conclusionRivaroxaban is effective and safe for the treatment of VTE in patients with active cancer.

Indexed as

Acute DiseaseAdultAgedAged, 80 and overBlood CoagulationDrug Administration ScheduleFactor Xa InhibitorsFemaleHemorrhageHumansIncidenceMaleMiddle AgedNeoplasmsProspective StudiesPulmonary EmbolismFactor Xa InhibitorsRivaroxabanNeoplasmsRecurrenceRivaroxabanTherapeuticsVenous thromboembolism

Identifiers

PMID29788694
PMCPMC6718768

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Registered trials

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.