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Single technology appraisal and highly specialised technologies evaluation: User guide for company evidence submission appendices

Appendix F: Adverse reactions

Appendix F: Adverse reactions

In appendix F, provide details of any studies that report additional adverse reactions to those reported by the studies identified in section 2.2. Include the following:

  • Details of the methodology used for the identification, selection and quality assessment of the studies.

  • Examples of search strategies for specific adverse reactions or generic adverse reaction terms. Key aspects of quality criteria for adverse reaction data can found in Systematic reviews: CRD's guidance for undertaking reviews in health care (University of York Centre for Reviews and Dissemination). Exact details of the search strategy used and a complete quality assessment for each trial should also be provided in appendix F.

    • Details of the methodology of the studies.

    • Adverse reactions. In a table provide details of adverse reactions for each intervention group. For each group, give the number with the adverse reaction and the frequency, the number in the group, and the percentage with the adverse reaction. Then present the relative risk and risk difference and associated 95% confidence intervals for each adverse reaction.

See section 2.10 of the main user guide for company evidence submission for full details of the information required here.


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