c212.trial.interval.data1

This data set contains count of the adverse events over the first two intervals of a clinical trial.

datasets

Methods for detecting safety signals in clinical trials using groupings of adverse events by body-system or system organ class. This work was supported by the Engineering and Physical Sciences Research Council (UK) (EPSRC) [award reference 1521741] and Frontier Science (Scotland) Ltd. The package title c212 is in reference to the original Engineering and Physical Sciences Research Council (UK) funded project which was named CASE 2/12.

Raymond Carragher

c212

Methods for Detecting Safety Signals in Clinical Trials Using
Body-Systems (System Organ Classes)

c212.trial.interval.data1 function

A dataframe with columns interval, I_index - the interval order, B - body-system, AE - adverse event, Group - 1 for control, 2 for treatment, Count - total adverse events that occurred in the interval, Exposure - the total time all at risk subjects spent in the interval.
The dataframe contains 1860 observations.

c212.trial.interval.data1: Interim analysis trial data.

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