PMID- 26483049
OWN - NLM
STAT- MEDLINE
DCOM- 20160922
LR  - 20200206
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 27
IP  - 1
DP  - 2016 Jan
TI  - The reporting of adverse events in oncology phase III trials: a comparison of the 
      current status versus the expectations of the EORTC members.
PG  - 192-8
LID - 10.1093/annonc/mdv485 [doi]
AB  - BACKGROUND: Determination of drug safety and tolerability is usually based on the 
      frequency of certain key adverse events (AEs) rather than the frequency of 
      all-grade toxicities. We assessed the reporting of key AEs in oncology 
      randomized, controlled trials (RCTs) and compared that with the expectations of 
      the European Organization for Research and Treatment of Cancer (EORTC) 
      membership. MATERIALS AND METHODS: RCTs reports published between 2007 and 2011 
      were reviewed regarding the reporting of key AEs, namely: grade 3/4 AEs, grade 5 
      AEs, and AEs resulting in study withdrawal or in dose reduction. Study 
      characteristics associated with better reporting of key AEs were investigated. 
      Finally, a survey was conducted among the EORTC membership to determine their 
      expectations on key AEs reporting. RESULTS: Although the frequency of grade 3/4 
      was reported in most reports (96%), only 17% of them described the reporting 
      threshold above which grade 3/4 AEs were included for reporting, raising the 
      possibility that important but less frequent grade 3/4 AEs might be 
      underreported. Frequency and nature of grade 5 AEs were adequately reported in 
      161 (50%) of manuscripts; AEs leading to study withdrawal in 61 manuscripts 
      (19%); and AEs leading to dose reduction in 43 manuscripts (13%). In contrast, 
      most EORTC members expected a comprehensive reporting of grade 5 AEs (96% of 
      EORTC member's responses), AEs leading to study withdrawal (86%) and AEs leading 
      to dose reduction (70%). In multivariate analysis, frequencies of grade 5 AEs 
      were less frequently reported in European trials (P = 0.004). Frequencies of AEs 
      leading to withdrawals were more frequently reported in trials funded by industry 
      (P = 0.005) and in trials including patients with breast or urological cancers (P 
      = 0.006). CONCLUSIONS: These findings suggest that current practice of key AEs 
      reporting remains highly variable and sometimes inadequate in oncology RCTs 
      reports. Current standards for safety reporting in RCTs should be revised to 
      emphasize the importance of key AEs reporting.
CI  - (c) The Author 2015. Published by Oxford University Press on behalf of the European 
      Society for Medical Oncology. All rights reserved. For permissions, please email: 
      journals.permissions@oup.com.
FAU - Maillet, D
AU  - Maillet D
AD  - Department of Medical Oncology, Institut de Cancerologie des Hospices Civils de 
      Lyon (IC-HCL), Lyon.
FAU - Blay, J Y
AU  - Blay JY
AD  - Department of Medical Oncology, Centre Leon Berard, Lyon, France EORTC, 
      Bruxelles, Belgium.
FAU - You, B
AU  - You B
AD  - Department of Medical Oncology, Institut de Cancerologie des Hospices Civils de 
      Lyon (IC-HCL), Lyon Department of Medical Oncology, Faculte de Medecine Lyon-Sud, 
      EMR UCBL/HCL 3738, Lyon, France.
FAU - Rachdi, A
AU  - Rachdi A
AD  - Department of Medical Oncology, Institut de Cancerologie des Hospices Civils de 
      Lyon (IC-HCL), Lyon.
FAU - Gan, H K
AU  - Gan HK
AD  - Medical Oncology Unit and Olivia Newton-John Cancer Research Institute, Austin 
      Hospital, Melbourne School of Cancer Medicine, La Trobe University, Bundoora, 
      Australia.
FAU - Peron, J
AU  - Peron J
AD  - Department of Medical Oncology, Institut de Cancerologie des Hospices Civils de 
      Lyon (IC-HCL), Lyon Biostatistics Unit, Hospices Civils de Lyon, Lyon Biometry 
      and Evolutionary Biology Laboratory, Health and Biostatistics Team, Villeurbanne, 
      France julien.peron@chu-lyon.fr.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20151019
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Clinical Trials, Phase III as Topic
MH  - Europe
MH  - Humans
MH  - Neoplasms/*drug therapy
MH  - Practice Guidelines as Topic
OTO - NOTNLM
OT  - CONSORT statement
OT  - EORTC
OT  - adverse events
OT  - grade 5 adverse events
OT  - phase III trial reports
EDAT- 2015/10/21 06:00
MHDA- 2016/09/23 06:00
CRDT- 2015/10/21 06:00
PHST- 2015/02/04 00:00 [received]
PHST- 2015/10/05 00:00 [accepted]
PHST- 2015/10/21 06:00 [entrez]
PHST- 2015/10/21 06:00 [pubmed]
PHST- 2016/09/23 06:00 [medline]
AID - S0923-7534(19)35338-4 [pii]
AID - 10.1093/annonc/mdv485 [doi]
PST - ppublish
SO  - Ann Oncol. 2016 Jan;27(1):192-8. doi: 10.1093/annonc/mdv485. Epub 2015 Oct 19.