1390P - Low adequacy between severe adverse events reporting in oncology phase III trials and expectations of the EORTC members

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications/Toxicities of Treatment
Bioethics, Legal, and Economic Issues
Presenter Denis Maillet
Citation Annals of Oncology (2014) 25 (suppl_4): iv486-iv493. 10.1093/annonc/mdu353
Authors D. Maillet1, J. Blay2, B. You1, J. Peron1
  • 1Oncologie, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR
  • 2University Claude Bernard Lyon I, Centre Léon Bérard, 69008 - Lyon/FR



Reports of randomized controlled trials (RCTs) published in oncology literature are generally poorly conform to the 2004 Consolidated Standards of Reporting Trials (CONSORT ) extension for harms. We assessed the consistency in between expectations of a panel of EORTC experts regarding reporting of AEs and the actual quality of publication of RCTs.


Reporting of severe-AEs, AEs related outcomes and composite AEs outcomes were reviewed in 325 oncology RCTs reports published between 2007 and 2011. An online survey was sent to the network of EORTC investigators to evaluate their expectation concerning the AE reporting. Then we compared AE reporting in phase III reports with EORTC member expectations. The characteristics of the article associated with better quality in AEs related outcomes reporting were also investigated.


A total of 211 EORTC members have responded to the survey. Among them, 99% thought that all lethal AEs (LAEs) should be reported and 95% thought that all AE leading to withdrawal should also be reported. Clearly described LAEs were found in 190 out of 325 RCTs (58%) and AEs leading to withdrawal were correctly reported in 53 out of 325 RCTs (16%). LAEs were more correctly reported in North-America / Intercontinental trials (p = 0.0004) and in trials testing a molecular targeted therapy (p = 0.016). AEs leading to withdrawals were more correctly reported in RCTs funded by industry (p = 0,001). Composite AEs such as “dermatologic AEs” or “neurologic AEs” were used in 95 out of 325 RCTs (29%); 25% of them were clearly described.


There are important discrepancies between the expectations of EORTC network investigators and the reporting quality of AE reporting in oncology phase III reports. Recommendations able to improve the reporting of severe-AE reporting in oncology phase III reports are discussed.


All authors have declared no conflicts of interest.