Evidence map›Paper›PMID 29907552›Full record

ReviewThe Lancet. Haematology2018

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.

Gita Thanarajasingam, Lori M Minasian, Frederic Baron, Franco Cavalli, R Angelo De Claro, Amylou C Dueck, Tarec C El-Galaly, Neil Everest, Jan Geissler, Christian Gisselbrecht and 30 more

Erratum issuedOpen access · greenAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Lancet. Haematology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 67 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 1 pooled it
9.8field-weighted citation impact, top 1% 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

67 citing papers in PubMed, 1 synthesis or guideline pooled it, 130 citations in OpenAlex.

  1. Pooled it
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  3. The potential impact of exercise upon symptom burden in adolescents and young adults undergoing cancer treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

40 authors at 20 institutions in 12 countries.

Gita ThanarajasingamDivision of Haematology, Mayo Clinic, Rochester, MN, USA. Electronic address: thanarajasingam.gita@mayo.edu.
Lori M MinasianNational Cancer Institute, National Institutes of Health, Department of Health & Human Services, Bethesda, MD, USA.
Frederic BaronDivision of Haematology, University of Liege, Liege, Belgium.
Franco CavalliOncology Institute of Southern Switzerland, Bellinzona, Switzlerand.
R Angelo De ClaroOffice of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Amylou C DueckDepartment of Health Sciences Research, Mayo Clinic, Scottsdale, AZ, USA.
Tarec C El-GalalyDepartment of Haematology, Aalborg University Hospital, Aalborg Denmark.
Neil EverestHaematology Clinical Evaluation Unit, Therapeutic Goods Administration, Department of Health, Symondston, ACT, Australia.
Jan GeisslerLeukaemia Patient Advocates Foundation, Bern, Switzerland.
Christian GisselbrechtHaemato-Oncology Department, Hopital Saint-Louis, Paris Diderot University VII, Paris, France.
John GribbenCentre for Haemato-Oncology, Barts Cancer Institute, London, UK.
Mary HorowitzDivision of Haematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, USA.
S Percy IvyNational Cancer Institute, National Institutes of Health, Department of Health & Human Services, Bethesda, MD, USA.
Caron A JacobsonDivision of Haematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Armand KeatingPrincess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Paul G KluetzOffice of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Aviva KraussOffice of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Yok Lam KwongDepartment of Haematology and Haematologic Oncology, University of Hong Kong, Hong Kong, China.
Richard F LittleNational Cancer Institute, National Institutes of Health, Department of Health & Human Services, Bethesda, MD, USA.
Francois-Xavier MahonUniversity of Bordeaux Cancer Institute, Bordeaux, France.
Matthew J MatasarLymphoma and Adult BMT Services, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
María-Victoria MateosHaematology Department, University Hospital of Salamanca-IBSAL, Salamanca, Spain.
Kristen McCulloughDivision of Haematology, Mayo Clinic, Rochester, MN, USA.
Robert S MillerCancerLinQ, American Society of Clinical Oncology, Alexandria, VA, USA.
Mohamad MohtyHaematology and Cellular Therapy Department, Saint-Antoine Hospital, University Pierre & Marie Curie, Paris, France.
Philippe MoreauUniversity Hospital of Nantes, Nantes, France.
Lindsay M MortonNational Cancer Institute, National Institutes of Health, Department of Health & Human Services, Bethesda, MD, USA.
Sumimasa NagaiUniversity of Tokyo, Tokyo, Japan; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Simon RulePlymouth University Medical School, Plymouth, UK.
Jeff SloanDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
Pieter SonneveldDepartment of Haematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.
Carrie A ThompsonDivision of Haematology, Mayo Clinic, Rochester, MN, USA.
Kyriaki TzoganiEuropean Medicines Agency, London, UK.
Flora E van LeeuwenNetherlands Cancer Institute, Amsterdam, Netherlands.
Galina VelikovaLeeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.
Diego VillaDivision of Medical Oncology, British Columbia Cancer Agency, University of British Columbia, Vancouver, BC, Canada.
John R WingardDivision of Haematology & Oncology, University of Florida College of Medicine, Gainesville, FL, USA.
Sophie WintrichMyelodysplastic Syndrome (MDS) Alliance and MDS UK Patient Support Group, London, UK.
John F SeymourDepartment of Haematology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Royal Melbourne Hospital, Melbourne, VIC, Australia; University of Melbourne, Melbourne, VIC, Australia.
Thomas M HabermannDivision of Haematology, Mayo Clinic, Rochester, MN, USA.
Mayo Clinic in Arizona · USNational Cancer Institute · USNational Institutes of Health · USUnited States Food and Drug Administration · USAalborg University Hospital · DKAmerican Society of Clinical Oncology · USBC Cancer Agency · CACenter for Drug Evaluation and Research · USCentre Hospitalier Universitaire de Nantes · FRDana-Farber Cancer Institute · USDélégation Paris 7 · FRDutch Cancer Society · NLErasmus MC Cancer Institute · NLFlorida College · USInstitute of Oncology Research · CHMayo Clinic in Florida · USMedical College of Wisconsin · USMemorial Sloan Kettering Cancer Center · USPharmaceuticals and Medical Devices Agency · JPPrincess Margaret Cancer Centre · CA

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
The Role of Monocytes in non-Hodgkin LymphomaP50CA097274 · NCI · UNIVERSITY OF IOWA · PI LENTZ, STEVEN R · 2002 to 2021
$45.7M
NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA097274
6 · The paper itself

Abstract

Tremendous progress in treatment and outcomes has been achieved across the whole range of haematological malignancies in the past two decades. Although cure rates for aggressive malignancies have increased, nowhere has progress been more impactful than in the management of typically incurable forms of haematological cancer. Population-based data have shown that 5-year survival for patients with chronic myelogenous and chronic lymphocytic leukaemia, indolent B-cell lymphomas, and multiple myeloma has improved markedly. This improvement is a result of substantial changes in disease management strategies in these malignancies. Several haematological malignancies are now chronic diseases that are treated with continuously administered therapies that have unique side-effects over time. In this Commission, an international panel of clinicians, clinical investigators, methodologists, regulators, and patient advocates representing a broad range of academic and clinical cancer expertise examine adverse events in haematological malignancies. The issues pertaining to assessment of adverse events examined here are relevant to a range of malignancies and have been, to date, underexplored in the context of haematology. The aim of this Commission is to improve toxicity assessment in clinical trials in haematological malignancies by critically examining the current process of adverse event assessment, highlighting the need to incorporate patient-reported outcomes, addressing issues unique to stem-cell transplantation and survivorship, appraising challenges in regulatory approval, and evaluating toxicity in real-world patients. We have identified a range of priority issues in these areas and defined potential solutions to challenges associated with adverse event assessment in the current treatment landscape of haematological malignancies.

Indexed as

Research DesignSafetyClinical Trials as TopicHematologic NeoplasmsHumans

Identifiers

PMID29907552
PMCPMC6261436
OpenAlexW2808391935

What OpenQuestion holds

Textmetadata
LicenceTDM
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.