Safety Information from Product Monograph
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Is there any acceptable presentation of the adverse events table including the data for both the intervention arm and the comparator arm in an APS, recognizing the trial was not powered to detect a difference? For multidrug regimens, these tables are useful to HCPs who need to understand which drug in a regimen is responsible for a particular adverse event, in order to inform dose reductions (specifically for trials where regimen ABC is compared to AB).
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Is there any acceptable presentation of the adverse events table including the data for both the intervention arm and the comparator arm in an APS, recognizing the trial was not powered to detect a difference? For multidrug regimens, these tables are useful to HCPs who need to understand which drug in a regimen is responsible for a particular adverse event, in order to inform dose reductions (specifically for trials where regimen ABC is compared to AB).
Hello @mbos
Safety claims must be supported by the TMA or by pre-defined statistically significant endpoints in a published, peer-reviewed, blinded, randomized controlled trial. AE charts from single studies that do not meet these criteria would not be acceptable (Code section 5.7, 5.7.1, 5.9). The presentation would be acceptable when based on data from the TMA with no additional conclusions drawn.
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Hello @mbos
Safety claims must be supported by the TMA or by pre-defined statistically significant endpoints in a published, peer-reviewed, blinded, randomized controlled trial. AE charts from single studies that do not meet these criteria would not be acceptable (Code section 5.7, 5.7.1, 5.9). The presentation would be acceptable when based on data from the TMA with no additional conclusions drawn.
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@jennifer-carroll Thanks - to clarify, we can present the AE table with the intervention and control arms from the product monograph 'as is' without any safety claim (just a descriptive table title _ Trial X Adverse Events).
Hey @mbos
A balanced and complete presentation of the AE profile from the TMA which reflect the same content and context, would be acceptable.
