Linked Life Data

18618431

Source:http://linkedlifedata.com/resource/pubmed/id/18618431

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
26
pubmed:dateCreated
2008-10-21
pubmed:abstractText
Different from the use of intention-to-treat (ITT) analysis for efficacy evaluation, many pharmaceutical companies currently use treatment emergent (TE) analysis for adverse event (AE) safety analysis. In the TE analysis, study period and AEs occurring after a pre-specified post-treatment window will not be included. One consideration for using the TE AE analysis is that including substantial off-drug period and events in the analysis may dilute the power for detecting safety signals especially if after discontinuation residual treatment effect diminishes quickly. We perform quantitative analyses to compare the unbiasedness and power of the ITT and TE AE analyses under several different settings and metrics (difference in rates and relative risk). Results show that unbiasedness and power are not always in the same direction. The choice of an approach for a particular trial should depend on the focus of the analysis. A data example is used to illustrate these points.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0277-6715
pubmed:author
pubmed:issnType
Print
pubmed:day
20
pubmed:volume
27
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
5356-76
pubmed:meshHeading
pubmed:year
2008
pubmed:articleTitle
Comparisons between ITT and treatment emergent adverse event analyses.
pubmed:affiliation
Biostatistics and Programming, Sanofi-Aventis, BX2-403A, 200 Crossing Boulevard, Bridgewater, NJ 08807, USA. hui.quan@sanofi-aventis.com
pubmed:publicationType
Journal Article, Comparative Study