Package index • gsm.safety

Safety widgets

Interactive safety.viz charts as htmlwidgets.

Widget_Histogram(): Histogram Widget
Widget_ShiftPlot(): Shift Plot Widget
Widget_DeltaDelta(): Delta-Delta Widget
Widget_ResultsOverTime(): Results Over Time Widget
Widget_OutlierExplorer(): Outlier Explorer Widget
Widget_AeTimelines(): AE Timelines Widget
Widget_AeExplorer(): Adverse Event Explorer Widget
Widget_HepExplorer(): Hepatic Safety Explorer (eDISH) Widget
Widget_QtExplorer(): QT Safety Explorer Widget

Data

ExampleData(): Example safety data

Metric steps

The steps behind the metric definitions in inst/workflow/2_metrics/: each turns a domain into the participant-level tier that its flagging metric counts.

Input_HysLaw(): Participant-level Hy's Law candidate tier from liver chemistry
Input_QtProlongation(): Participant-level QTc prolongation tier from ECG data
Input_SafetyAE(): Participant-level serious / related / discontinuation AE tier

Study census

The safety overview’s denominators, exposure and data coverage.

SafetyCensus(): Study census, exposure and data coverage for a safety overview

Reports

SaveWidgetReport(): Save a safety widget as a standalone HTML report