safety dataset

Example of safety data

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

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

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