PMID- 31055176
OWN - NLM
STAT- MEDLINE
DCOM- 20200525
LR  - 20200525
IS  - 1878-5921 (Electronic)
IS  - 0895-4356 (Linking)
VI  - 113
DP  - 2019 Sep
TI  - Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic 
      adverse events.
PG  - 11-19
LID - S0895-4356(18)31109-0 [pii]
LID - 10.1016/j.jclinepi.2019.04.020 [doi]
AB  - OBJECTIVE: We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a 
      study describing the assessment and reporting AEs in clinical trials. STUDY 
      DESIGN AND SETTING: We examined 21 trials of gabapentin for neuropathic pain (52 
      sources) and seven trials of quetiapine for bipolar depression (80 sources) using 
      data from the Multiple Data Sources study. We extracted and compared information 
      about nonsystematic AEs (i.e., AEs that were not assessed for every participant), 
      including AEs categorized as "serious." We recorded whether AEs were grouped by 
      anatomic or physiological system. RESULTS: Trials of the same drug reported 
      information about different AEs. Information in public sources was inadequate for 
      decision-making. No public source reported all AEs, or all serious AEs, 
      identified in nonpublic sources about the same trial. Of trials with only public 
      sources, 2/15 (13%) gabapentin and 0/3 (0%) quetiapine trials grouped AEs by 
      anatomic or physiological system. CONCLUSION: Public sources contained little 
      information about nonsystematic AEs, including serious AEs. Grouping might make 
      nonsystematic AEs easier to detect; however, most public sources did not report 
      grouped AEs. Standards are needed to improve the collection and reporting of 
      nonsystematic AEs so that stakeholders can use trials to assess the balance of 
      potential benefits and harms.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Mayo-Wilson, Evan
AU  - Mayo-Wilson E
AD  - Department of Epidemiology, Johns Hopkins University Bloomberg School of Public 
      Health, 615 North Wolfe Street, Baltimore, MD 21205, USA. Electronic address: 
      evan.mayo-wilson@jhu.edu.
FAU - Fusco, Nicole
AU  - Fusco N
AD  - Department of Epidemiology, Johns Hopkins University Bloomberg School of Public 
      Health, 615 North Wolfe Street, Baltimore, MD 21205, USA.
FAU - Li, Tianjing
AU  - Li T
AD  - Department of Epidemiology, Johns Hopkins University Bloomberg School of Public 
      Health, 615 North Wolfe Street, Baltimore, MD 21205, USA.
FAU - Hong, Hwanhee
AU  - Hong H
AD  - Department of Mental Health, Johns Hopkins University Bloomberg School of Public 
      Health, 624 N Broadway, Hampton House, Baltimore, MD 21205, USA.
FAU - Canner, Joseph K
AU  - Canner JK
AD  - Department of Surgery, Johns Hopkins University School of Medicine, 600 North 
      Wolfe Street, Blalock 1202, Baltimore, MD 21287, USA.
FAU - Dickersin, Kay
AU  - Dickersin K
AD  - Department of Epidemiology, Johns Hopkins University Bloomberg School of Public 
      Health, 615 North Wolfe Street, Baltimore, MD 21205, USA.
CN  - MUDS investigators
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Systematic Review
DEP - 20190502
PL  - United States
TA  - J Clin Epidemiol
JT  - Journal of clinical epidemiology
JID - 8801383
RN  - 2S3PL1B6UJ (Quetiapine Fumarate)
RN  - 6CW7F3G59X (Gabapentin)
SB  - IM
MH  - Bipolar Disorder/*drug therapy
MH  - Data Accuracy
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Gabapentin/*adverse effects/*therapeutic use
MH  - Humans
MH  - Neuralgia/*drug therapy
MH  - Quetiapine Fumarate/*adverse effects/*therapeutic use
MH  - Randomized Controlled Trials as Topic/*statistics & numerical data
MH  - Research Report
OTO - NOTNLM
OT  - Adverse events
OT  - Clinical trials
OT  - Drug safety
OT  - Harms
OT  - Open science
OT  - Reporting bias
FIR - Bertizzolo, Lorenzo
IR  - Bertizzolo L
FIR - Cowley, Terrie
IR  - Cowley T
FIR - Doshi, Peter
IR  - Doshi P
FIR - Ehmsen, Jeffrey
IR  - Ehmsen J
FIR - Gresham, Gillian
IR  - Gresham G
FIR - Guo, Nan
IR  - Guo N
FIR - Haythornthwaite, Jennifer
IR  - Haythornthwaite J
FIR - Heyward, James
IR  - Heyward J
FIR - Pham, Diana
IR  - Pham D
FIR - Payne, Jennifer
IR  - Payne J
FIR - Rosman, Lori
IR  - Rosman L
FIR - Stuart, Elizabeth
IR  - Stuart E
FIR - Suarez-Cuervo, Catalina
IR  - Suarez-Cuervo C
FIR - Tolbert, Elizabeth
IR  - Tolbert E
FIR - Twose, Claire
IR  - Twose C
FIR - Vedula, Swaroop
IR  - Vedula S
EDAT- 2019/05/06 06:00
MHDA- 2020/05/26 06:00
CRDT- 2019/05/06 06:00
PHST- 2018/12/13 00:00 [received]
PHST- 2019/03/04 00:00 [revised]
PHST- 2019/04/05 00:00 [accepted]
PHST- 2019/05/06 06:00 [pubmed]
PHST- 2020/05/26 06:00 [medline]
PHST- 2019/05/06 06:00 [entrez]
AID - S0895-4356(18)31109-0 [pii]
AID - 10.1016/j.jclinepi.2019.04.020 [doi]
PST - ppublish
SO  - J Clin Epidemiol. 2019 Sep;113:11-19. doi: 10.1016/j.jclinepi.2019.04.020. Epub 
      2019 May 2.