PMID- 21191383
OWN - NLM
STAT- MEDLINE
DCOM- 20110228
LR  - 20220410
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Print)
IS  - 0009-9236 (Linking)
VI  - 89
IP  - 2
DP  - 2011 Feb
TI  - Biclustering of adverse drug events in the FDA's spontaneous reporting system.
PG  - 243-50
LID - 10.1038/clpt.2010.285 [doi]
AB  - In this article, we present a new pharmacovigilance data mining technique based 
      on the biclustering paradigm, which is designed to identify drug groups that 
      share a common set of adverse events (AEs) in the spontaneous reporting system 
      (SRS) of the US Food and Drug Administration (FDA). A taxonomy of biclusters is 
      developed, revealing that a significant number of bona fide adverse drug event 
      (ADE) biclusters have been identified. Statistical tests indicate that it is 
      extremely unlikely that the bicluster structures thus discovered, as well as 
      their content, could have arisen by mere chance. Some of the biclusters 
      classified as indeterminate provide support for previously unrecognized and 
      potentially novel ADEs. In addition, we demonstrate the potential importance of 
      the proposed methodology in several important aspects of pharmacovigilance such 
      as providing insight into the etiology of ADEs, facilitating the identification 
      of novel ADEs, suggesting methods and a rationale for aggregating terminologies, 
      highlighting areas of focus, and providing an exploratory tool for data mining.
FAU - Harpaz, R
AU  - Harpaz R
AD  - Department of Biomedical Informatics, Columbia University Medical Center, New 
      York, New York, USA. rave.harpaz@dbmi.columbia.edu
FAU - Perez, H
AU  - Perez H
FAU - Chase, H S
AU  - Chase HS
FAU - Rabadan, R
AU  - Rabadan R
FAU - Hripcsak, G
AU  - Hripcsak G
FAU - Friedman, C
AU  - Friedman C
LA  - eng
GR  - R01LM006910/LM/NLM NIH HHS/United States
GR  - R01 LM006910/LM/NLM NIH HHS/United States
GR  - 3R01LM010016-01S1/LM/NLM NIH HHS/United States
GR  - R01 LM010016-01S2/LM/NLM NIH HHS/United States
GR  - 3R01LM010016-02S1/LM/NLM NIH HHS/United States
GR  - R01 LM010016/LM/NLM NIH HHS/United States
GR  - 1R01LM010016/LM/NLM NIH HHS/United States
GR  - R01 LM010016-01/LM/NLM NIH HHS/United States
GR  - R01 LM010016-01S1/LM/NLM NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20101229
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - *Cluster Analysis
MH  - Data Collection
MH  - Data Mining
MH  - Humans
MH  - United States
MH  - *United States Food and Drug Administration
PMC - PMC3282185
MID - NIHMS353976
EDAT- 2010/12/31 06:00
MHDA- 2011/03/01 06:00
PMCR- 2012/02/19
CRDT- 2010/12/31 06:00
PHST- 2010/12/31 06:00 [entrez]
PHST- 2010/12/31 06:00 [pubmed]
PHST- 2011/03/01 06:00 [medline]
PHST- 2012/02/19 00:00 [pmc-release]
AID - clpt2010285 [pii]
AID - 10.1038/clpt.2010.285 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2011 Feb;89(2):243-50. doi: 10.1038/clpt.2010.285. Epub 2010 
      Dec 29.