548 - 1. Can a modified intent-to-treat (mITT) analysis be used in promotional materials? mITT analysis excluded patients who discontinued due to adverse event, lost to follow-up, or subject withdrawal. 2. If yes, would also need to show the primary endpoint analysis, ITT, as shown in the PM? 3. Are there any specific requirements on how the primary ITT and mITT analyses need to be displayed?

  • Claims supported by a superiority trial should be based on ITT. This means that all patients who were enrolled & randomly allocated to treatment are included in the analysis and are analysed in the groups to which they were randomized.

    Note that mITT, by definition, is a deviation from ITT. It should not be used as the basis/evidence for a claim.