safety_summary_adam: Calculate frequency tables based on ADaM data.

In eudract: Creates Safety Results Summary in XML to Upload to EudraCT, or ClinicalTrials.gov

Calculate frequency tables based on ADaM data.

Description

Calculate frequency tables based on ADaM data.

Usage

safety_summary_adam(
  adsl,
  adae,
  freq_threshold = 0,
  na.action = na.fail,
  related_terms = c("POSSIBLE", "PROBABLE", "DEFINITELY", "Y")
)

Arguments

adsl	ADaM Subject-level analysis data set
adae	ADaM Adverse Event data set
freq_threshold	a value on a percentage scale at which to remove events if the incidence falls below. Defaults to 0
na.action	a function that indicates what should happen if the data contain missing values. The default is na.fail as both repositories will not accept any missing values in the upload. Alternatives could be na.omit, na.exclude, or na.pass.
related_terms	The set of terms used in adae$AEREL to identify related events.

Details

It is worth highlighting that the CDISC standards need to be followed. There must be an ARM variable in the adsl data. Screen failures must be filtered out. It is up to the user to manipulate the input data as required.

Value

a list of three data frames: GROUP, SERIOUS, NON_SERIOUS. Each contains the summary statistics required by EudraCT, and is suitable for export.

See Also

safety_summary eudract_convert simple_safety_xml

Examples

safety_summary_adam(
 pharmaverseadam::adsl |> dplyr::filter(ARM != "Screen Failure"), 
 pharmaverseadam::adae)

eudract documentation built on Jan. 9, 2026, 5:09 p.m.