PMID- 27274655
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20191120
IS  - 1178-2595 (Print)
IS  - 1178-2595 (Linking)
VI  - 30
IP  - 2
DP  - 2016 Apr
TI  - A Method for Retrieval of Adverse Event Terms in Clinical Trial Databases Using 
      Standardised MedDRA Queries.
PG  - 103-108
AB  - BACKGROUND: Standardized MedDRA Queries (SMQs) are sets of terms determined by 
      experts that are used to identify adverse events (AEs) related to different 
      disease processes. Their use can be challenging because most SMQs have 50 to 100 
      preferred terms and AE databases can have many thousands of events. AIM: The aim 
      of this study is to develop a technique where AEs corresponding to preferred 
      terms in SMQs may be easily detected. METHODOLOGY: The method I developed uses 
      the Table Join function of the JMP((R)) software program to quickly and easily 
      probe clinical trial AE databases. The SMQ Severe cutaneous adverse reactions was 
      used as a probe in a mock AE dataset. Potentially confounding demographic or 
      study-specific factors were evaluated by combining these datasets with the 
      dataset containing the AEs identified with the SMQs. RESULTS: AEs were 
      successfully detected in an AE database using the method described. Cases with 
      potential confounding factors, such as concomitant medications, were identified. 
      CONCLUSIONS: The method developed allows for AEs to be found in clinical trial 
      databases and evaluated using software programs that are readily available to 
      clinical researchers.
FAU - Breder, Christopher D
AU  - Breder CD
AD  - Division of Neurology Products (DNP), Office of New Drugs (OND), Center for Drug 
      Evaluation and Research (CDER), Food and Drug Administration (FDA), White Oak, 
      Bldg. 22 Rm. 4218 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
LA  - eng
GR  - FD999999/Intramural FDA HHS/United States
PT  - Journal Article
PL  - New Zealand
TA  - Pharmaceut Med
JT  - Pharmaceutical medicine
JID - 101471195
PMC - PMC4886503
MID - NIHMS788733
COIS- Conflict of interest The author is a medical officer with the United States Food 
      and Drug administration. The views expressed in this paper represent the opinion 
      of the author and do not necessarily represent the views of the FDA. The author 
      is a Deputy Topic Leader for the FDA in the ICH M1 Points to Consider Group and 
      also directs the FDA's MedDRA Coordinating Working Group. The author has no 
      affiliation or financial interest in the software vendor (SAS((R)) Institute).
EDAT- 2016/06/09 06:00
MHDA- 2016/06/09 06:01
PMCR- 2017/04/01
CRDT- 2016/06/09 06:00
PHST- 2016/06/09 06:00 [entrez]
PHST- 2016/06/09 06:00 [pubmed]
PHST- 2016/06/09 06:01 [medline]
PHST- 2017/04/01 00:00 [pmc-release]
AID - 10.1007/s40290-016-0136-8 [doi]
PST - ppublish
SO  - Pharmaceut Med. 2016 Apr;30(2):103-108. doi: 10.1007/s40290-016-0136-8.