Evidence map›Paper›PMID 32129511›Full record

Trial reportAmerican journal of hematology2020

Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials.

David J Kuter, Donald M Arnold, Francesco Rodeghiero, Ann Janssens, Dominik Selleslag, Robert Bird, Adrian Newland, Jiri Mayer, Kejia Wang, Robert Olie

4 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of hematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.6field-weighted citation impact, top 14% 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.

NCT00102323 phase3completednot on this map

A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy

TypeinterventionalSponsorAmgenRan2005 to 2007Enrolled63ConditionsThrombocytopenia, Idiopathic Thrombocytopenic PurpuraArmsPlacebo, AMG 531
NCT00102336 phase3completednot on this map

A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy

TypeinterventionalSponsorAmgenRan2005 to 2007Enrolled62ConditionsThrombocytopenia, Idiopathic Thrombocytopenic PurpuraArmsAMG 531, Placebo
NCT00907478 phase4completednot on this map

A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

TypeinterventionalSponsorAmgenRan2009 to 2014Enrolled169ConditionsThrombocytopenia, Idiopathic Thrombocytopenic PurpuraArmsromiplostim
NCT01143038 phase2completednot on this map

A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim

TypeinterventionalSponsorAmgenRan2010 to 2013Enrolled75ConditionsIdiopathic Thrombocytopenic PurpuraArmsRomiplostim
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 14 citations in OpenAlex.

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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

10 authors at 10 institutions in 8 countries.

David J KuterHematology Division, Massachusetts General Hospital, Boston, Massachusetts, USA.ORCID 0000-0003-2084-8810
Donald M ArnoldCanadian Blood Services and Department of Medicine, McMaster Centre for Transfusion Research, Michael G DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
Francesco RodeghieroHaematology Project Foundation, Affiliated to the Department of Haematology, S. Bortolo Hospital, Vicenza, Italy.
Ann JanssensDepartment of Hematology, University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium.
Dominik SelleslagDepartment of Hematology, AZ Sint Jan Brugge, Bruges, Belgium.
Robert BirdDivision of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia.
Adrian NewlandThe Pathology Clinical Academic Group, The Royal London Hospital, London, UK.
Jiri MayerDepartment of Internal Medicine, Haematology and Oncology, Masaryk University and University Hospital Brno, Brno, Czech Republic.
Kejia WangAmgen Inc, Thousand Oaks, California, USA.
Robert OlieAmgen (Europe) GmbH, Rotkreuz, Switzerland.
Amgen (Switzerland) · CHAmgen (United States) · USAZ Sint-Jan · BECanadian Blood Services · CAMasaryk University · CZMassachusetts General Hospital · USOspedale San Bortolo · ITPrincess Alexandra Hospital · AURoyal London Hospital · GBUniversitair Ziekenhuis Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Romiplostim self-administration by patients or caregivers may offer time/cost savings to healthcare professionals (HCPs) and convenience for patients who avoid weekly clinic visits. We performed an integrated analysis of five clinical trials to evaluate the efficacy and safety of romiplostim self-administration. Data were analyzed from adults with immune thrombocytopenia (ITP) who received weekly romiplostim via self-administration or from an HCP. Patients who achieved a stable romiplostim dose for ≥3 weeks (HCP group ≥5 weeks to provide an appropriate index date to enable comparisons with the self-administration group) with platelet counts ≥50 × 10

Indexed as

Databases, FactualAdolescentAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedPlatelet CountPurpura, Thrombocytopenic, IdiopathicReceptors, FcRecombinant Fusion ProteinsSelf AdministrationThrombopoietinReceptors, FcRecombinant Fusion ProteinsromiplostimThrombopoietin

Identifiers

PMID32129511
PMCPMC7318268
OpenAlexW3009946828

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.