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2006 analysis

The US Food and Drug Administration (FDA) has requested data from antidepressant manufacturers for an analysis of adult suicidality data from short-term placebo-controlled trials. GSK elected to conduct an analysis of its own data from short- and long-term placebo-controlled paroxetine trials in adults, building upon what was done in previous analyses and the developing expertise in the field. Please find below the descriptions of and links to documents related to the 2006 analysis.

• Summary/Briefing Document: A summary of the results from the 2006 analysis has been submitted to regulatory agencies in the United States, Europe, and other countries around the world. This summary (also known as a Briefing Document) provides both safety data (related to suicidal behaviour and ideation) and efficacy data (how well symptoms of psychiatric disorders respond to paroxetine), as well as GSK's conclusions from the analysis.
  
  > Download the Briefing Document (PDF 41.6 KB)

• Appendices to the Briefing Document: These Appendices provide the datasets and clinical narratives that are referenced in the Briefing Document. Note that Appendix I contains the data analysis plan.
  
  > Download the Appendix I (PDF 217 KB)
  > Download the Appendix II (PDF 240 KB)
  > Download the Appendix III (PDF 839 KB)
  > Download the Appendix IV (PDF 88 KB)
  > Download the Appendix V and VI (PDF 164 KB)
  > Download the Appendix VII (PDF 74 KB)

• Information for healthcare providers
  
  > US HCPs (PDF 43 KB)
          > FDA's MedWatch Adverse Event Reporting Program
  
  European healthcare providers can get more information by consulting the paroxetine SPC (Summary of Product Characteristics), sections 4.4 and 5.1.

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