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at least 4 cases in group 1+2; significant disproportionality in group 1+2 that persists through the cumulative approach; significant disproportionality in group 1+2 (ROR adjusted for confounders) in the stratum without AZCERT drugs (effect modifier); not included in the AZCERT lists (downloaded in the version available as of June 2011).
By contrast, our analysis found that aripiprazole was reported in 46 cases of TdP/QT abnormalities with significant disproportionality in the two strata without AZCERT drugs, although the intraclass ROR was not significant.
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But the spokeswoman added: "The Commissioner has recognised that there remains a risk that the MPS is still institutionally racist in some of what it does because there remain elements of disproportionality, despite significant progress over many years".
The results of all 6 tests showed disproportionality and were strongly significant (P<<0.0001).
Notably, for all APs with significant ROR in group 1 or 2, disproportionality persisted throughout all remaining groups.
* Statistically significant ROR Table 3 shows the results of disproportionality analyses, stratified and adjusted for covariates (see ' Methods'), performed on 29 APs with cases of TdP/QT abnormalities.
This disproportionality is indeed indicative for a significant fraction of frameshifting indels being located in erroneously predicted Ensembl exons, but still a substantial number of events cannot be explained this way.
Notably, all APs with disproportionality in group 1 or 2 maintained significant ROR when groups 3 and 4 were added to the analysis.
Disproportionality: Disproportionality analysis is an important tool for identifying new signals/patterns in spontaneous AE report databases.
One may note, however, that we find a significant effect if we applied a weight (basewt) correcting only for the disproportionality of the sample.
So, why is there still disproportionality?
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com