SS P08 Events of Special Interest White Paper

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White Paper Title and Lead

Title = Analyses and Displays Associated with Events of Special Interest
Lead = To be Determined

Status

Planned.

Plan

History

Notes

  • 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.

Category Identification


Last revised by Jmbodart,10/13/2015