SS P08 Events of Special Interest White Paper
From PHUSE Wiki
White Paper Title and Lead
Title = Analyses and Displays Associated with Events of Special Interest
Lead = To be Determined
- Include events that might require additional characterization - onset, duration, recovery, recurrence.
- Methods when n, N, % isn't appropriate.
- Using CTCAE grading when more the low/high/normal makes sense. (Address alternative thresholds when LLN/ULN overlap with designated grade values.)
- Include events of special interest that might be rare - patient profile might be the display of choice. (Avoid over-analyzing.)
- Include discussion and/or recommendations if and when within-treatment change is of value.
- Include potential use of cumulative meta-analysis plot (comment from outlier/shift white paper, but can be addressed here?)
- Consider creating a list of labs that might required special handling due to distribution. (E.g., which might need multiple of LLN/ULN instead of "normal" scatterplot, etc.)
- Consider role of the "collage" for integrated summaries - one row per study, different columns for combinations of treatments across the phases.
Last revised by Jmbodart,10/13/2015