safety

A dataset containing some example data of safety event in raw source format

datasets

The remit of the European Clinical Trials Data Base (EudraCT <https://eudract.ema.europa.eu/> ) is to provide open access to summaries of all registered clinical trial results; thus aiming to prevent non-reporting of negative results and provide open-access to results to inform future research. The amount of information required and the format of the results, however, imposes a large extra workload at the end of studies on clinical trial units. In particular, the adverse-event-reporting component requires entering: each unique combination of treatment group and safety event; for every such event above, a further 4 pieces of information (body system, number of occurrences, number of subjects, number exposed) for non-serious events, plus an extra three pieces of data for serious adverse events (numbers of causally related events, deaths, causally related deaths). This package prepares the required statistics needed by EudraCT and formats them into the precise requirements to directly upload an XML file into the web portal, with no further data entry by hand.

Simon Bond

eudract

Creates Safety Results Summary in XML to Upload to EudraCT

Beatrice Pantaleo

safety function

a data frame with 8 columns and 16 rows<dl class="dl-horizontal">
 <dt>pt</dt><dd>meddra preferred term code</dd>
 <dt>subjid</dt><dd>a unique subject identifier</dd>
 <dt>related</dt><dd>a logical indicating if the event is related to the treatment</dd>
 <dt>soc</dt><dd>the meddra code for the System Organ Class</dd>
 <dt>fatal</dt><dd>a numerical 0/1 to indicate if the event was fatal</dd>
 <dt>serious</dt><dd>a numerical 0/1 to indicate if the event was serious</dd>
 <dt>group</dt><dd>the treatment group for the subject</dd>
 <dt>term</dt><dd>a text description of the event. Needs to be matching 1-1 with the pt code</dd>
</dl>

Format

Example of safety data — safety

a data frame with 8 columns and 16 rows<dl class='dl-horizontal'>
 <dt>pt</dt><dd>meddra preferred term code</dd>
 <dt>subjid</dt><dd>a unique subject identifier</dd>
 <dt>related</dt><dd>a logical indicating if the event is related to the treatment</dd>
 <dt>soc</dt><dd>the meddra code for the System Organ Class</dd>
 <dt>fatal</dt><dd>a numerical 0/1 to indicate if the event was fatal</dd>
 <dt>serious</dt><dd>a numerical 0/1 to indicate if the event was serious</dd>
 <dt>group</dt><dd>the treatment group for the subject</dd>
 <dt>term</dt><dd>a text description of the event. Needs to be matching 1-1 with the pt code</dd>
</dl>

safety: Example of safety data

Description

Usage

Arguments

Format

Details