Add AE observation — add_ae_observation • nif

Usage

add_ae_observation(
  nif,
  sdtm,
  ae_term,
  ae_field = "AEDECOD",
  parent = NULL,
  cmt = NULL,
  subject_filter = "!ACTARMCD %in% c('SCRNFAIL', 'NOTTRT')",
  observation_filter = "TRUE",
  keep = "",
  debug = FALSE,
  silent = NULL
)

Arguments

nif

A nif object.

sdtm

A sdtm object.

ae_term

The AE term as character.

ae_field

The field in which the AE term is specified in. Can be:

AEDECOD: Dictionary-derived term
AELLT: Lowest-level term
AEHLT: High-level term
AEHLGT: High-level group term
AESOC: System organ class
AEBODSYS: Body system or organ class

or any other field from the 'AE' domain

parent

The parent compound as character.

cmt

The compartment as numeric.

subject_filter

A subject filter term.

observation_filter

An observation filter term.

keep

Columns to keep, as character.

debug

Include debug fields, as logical.

silent

Suppress messages, defaults to nif_option setting, if NULL.

Value

A nif object.

Details

This function adds AE events as observations with the time of the AE onset as the observation time point and the severity grade as the dependent variable.