safety

0th

Percentile

Example of safety data

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

Keywords
datasets
Usage
safety
Details

The data contains one row per patient-event. So the numbers exposed in each arm cannot be inferred from these data, as patients with no events will not be included in these data.

The variable names and formats are those required by safety_summary. The variable pt is not strictly required. An alternative to soc would be the equivalent character string from soc_code

Format

a data frame with 8 columns and 16 rows

pt

meddra preferred term code

subjid

a unique subject identifier

related

a logical indicating if the event is related to the treatment

soc

the meddra code for the System Organ Class

fatal

a numerical 0/1 to indicate if the event was fatal

serious

a numerical 0/1 to indicate if the event was serious

group

the treatment group for the subject

term

a text description of the event. Needs to be matching 1-1 with the pt code

Aliases
  • safety
Documentation reproduced from package eudract, version 0.9.0, License: GPL-2

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