# Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance), Division 10

Extent: E+W+S+N.I.

Results: comprising the following subsections:
10.1.Participants: numbers of study subjects at each stage of study. In the case of a systematic review or meta-analysis, number of studies screened, assessed for eligibility and included in the review with reasons for exclusion at each stage.
10.2.Descriptive data: characteristics of study participants, information on exposures and potential confounders and number of participants with missing data. In the case of a systematic review or meta-analysis, characteristics of each study from which data were extracted.
10.3.Outcome data: numbers of study subjects across categories of main outcomes.
10.4.Main results: unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision. Where relevant, estimates of relative risk shall be translated into absolute risk for a meaningful time period.
10.5.Other analyses.
10.6.Adverse events and adverse reactions.

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Source: https://www.legislation.gov.uk/eur/2012/520/annex/III/division/3/division/10 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/annex-III/division-3/division-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.