title: Aggregated adverse-events outcomes in oncology phase III reports: A systematic review.
abstract: BACKGROUND
  Randomised controlled trials (RCTs) represent a major source of information on treatment-related adverse events (AEs). In this study, we reviewed the use and the reporting methods of aggregated-AEs (A-AEs) outcomes in RCTs reports published in oncology and compared that to the expectations of European Organisation for Research and Treatment of Cancer (EORTC) membership.
  
  
  METHODS
  RCTs reports published between 2007 and 2011 were reviewed regarding the reporting of A-AEs-outcomes. A-AEs were defined as summary outcome combining several related AEs, usually grouped by organ system e.g. cardiac-AEs, dermatologic-AEs. Trial characteristics associated with the use of A-AEs outcomes were investigated. The expectation of EORTC members concerning A-AEs utilisation was queried through a survey.
  
  
  RESULTS
  Among 325 RCTs published between 2007 and 2011, 94 (29%) included one or more A-AE outcomes. A clear description of the nature of AEs included in such aggregations was provided in 19 articles (20%). No description of A-AEs was conversely provided in the other 75 articles (80%). The most commonly used A-AEs-outcomes were dermatologic-AEs (45%) and cardiac-AEs (33%). In multivariate analysis, the use of A-AEs outcomes was more frequent when trials were conducted in Europe (p = 0.038) and in trials performed on colon/rectal cancers (p = 0.016). Finally, there is no consensus of EORTC members regarding the utilisation of A-AEs but a majority of them (88%) felt that a clear description of A-AEs should systematically be reported.
  
  
  CONCLUSIONS
  The use of A-AEs is infrequent in oncology RCT manuscripts although their use is accepted by most clinicians. However, a clear definition of A-AEs is strongly recommended if they are to be used in order to avoid a loss of important details about drug toxicities that is useful to clinicians.
authors.affiliation: Medical Oncology Department, Centre Hospitalier Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), CITOHL, F-69310, Pierre-Bénite, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Maillet
authors.affiliation: Medical Oncology Unit, Olivia Newton-John Cancer and Wellness Centre, Austin Hospital, Melbourne, Victoria, Australia; School of Cancer Medicine, La Trobe University, Melbourne, Australia.
authors.forename: Hui K
authors.initials: HK
authors.lastname: Gan
authors.affiliation: Medical Oncology Department, Centre Léon Bérard, Lyon, France; EORTC, 83 Avenue Mounier, Bruxelles, Belgium.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Blay
authors.affiliation: Medical Oncology Department, Centre Hospitalier Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), CITOHL, F-69310, Pierre-Bénite, France; EMR UCBL/HCL 3738, Faculté de Médecine Lyon-Sud, F-69600, Oullins, France; Université de Lyon, F-69622, Lyon, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: You
authors.affiliation: Medical Oncology Department, Centre Hospitalier Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), CITOHL, F-69310, Pierre-Bénite, France; Hospices Civils de Lyon, Biostatistics Unit, F-69003, Lyon, France; CNRS UMR 5558, Biometry and Evolutionary Biology Laboratory, Health and Biostatistics Team, Villeurbanne, France. Electronic address: julien.peron@chu-lyon.fr.
authors.forename: Julien
authors.initials: J
authors.lastname: Péron
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D000970:Antineoplastic Agents / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000209:etiology*; D006801:Humans; D008495:Medical Oncology / Q000379:methods* / Q000592:standards; D015999:Multivariate Analysis; D009369:Neoplasms / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design / Q000592:standards; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents
keywords: Aggregated adverse events outcomes; EORTC; Methods; Neoplasms; Publishing standards; Randomised controlled trials as topic; Research designs; Research standards