Evidence map›Paper›PMID 35079961›Full record

Trial reportInternational journal of hematology2022

Apixaban in Japanese patients with cancer-associated venous thromboembolism: a multi-center phase II trial.

Yoshinori Imamura, Kazunori Otsui, Kenta Mori, Koichi Kitagawa, Hideaki Okada, Akito Hata, Hidetoshi Hayashi, Taku Nose, Shinya Ohata, Yoshiharu Miyata and 6 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2022. 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
1.3field-weighted citation impact, top 22% 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

0 citing papers in PubMed, 6 citations in OpenAlex.

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

16 authors at 3 institutions in 1 country.

Yoshinori ImamuraMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan. yimamura@med.kobe-u.ac.jp.ORCID http://orcid.org/0000-0002-5202-531X
Kazunori OtsuiGeneral Internal Medicine, Kobe University Hospital, Kobe, Japan.
Kenta MoriGeneral Internal Medicine, Kobe University Hospital, Kobe, Japan.
Koichi KitagawaMedical Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan.
Hideaki OkadaMedical Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan.
Akito HataThoracic Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan.
Hidetoshi HayashiMedical Oncology, Kindai University Faculty of Medicine, Osakasayama, Japan.
Taku NoseMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Shinya OhataMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Yoshiharu MiyataMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Yohei FunakoshiMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Masanori ToyodaMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Kimikazu YakushijinMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Naomi KiyotaMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Hiroshi MatsuokaMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Hironobu MinamiMedical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Kobe University Hospital · JPKobe Medical Center · JPKindai University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent pivotal phase III trials involving direct oral anticoagulant (DOAC) versus low molecular weight heparin have demonstrated the utility of DOACs in Western patients with cancer-associated venous thromboembolism (VTE). However, these trials did not include Japanese patients. This phase II trial evaluated the safety and efficacy of apixaban in Japanese patients with cancer-associated VTE (UMIN000028447). METHOD AND

resultsApixaban was initiated at 10 mg twice daily for 7 days, followed by 5 mg twice daily for 23 weeks. The primary endpoint was the incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period. The study was terminated due to safety concerns after enrolling 27 patients. Median age was 71 years; median body weight was 51.3 kg; and major primary tumor sites were the gastrointestinal tract (26%) and lung (19%). During the median follow-up period of 5.4 months, major or CRNM bleeding occurred in in 26% of patients (major, n = 5; CRNM, n = 2; 95% confidence interval, 11-46%). No recurrent VTE or VTE-related death occurred. Estimated overall survival at 6 months was 68%.

conclusionThis study demonstrated the excessive bleeding risk of apixaban at the standard dose in Japanese patients with cancer-associated VTE.

Indexed as

NeoplasmsVenous ThromboembolismAdministration, OralAgedAnticoagulantsHumansJapanPyrazolesPyridonesAnticoagulantsapixabanPyrazolesPyridonesApixabanCancer-associated venous thromboembolismJapanesePhase II trial

Identifiers

PMID35079961
OpenAlexW4206918788

What OpenQuestion holds

Textmetadata
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.