irbtox_summary: Create summary of AEs for Mayo DSMB reports

In sjacobson94/clinicaltrials: A Collection of Functions for use in CCS

Description

This function is design to replicate irbtoxrep.sas macro AE summary output for Mayo DSMB reports.

Usage

irbtox_summary(
  cytox,
  id = "dcntr_id",
  byvar = "arm",
  grade.term = "grade",
  relation.term = "rel_smed",
  tox.term = "toxicity",
  prot_num = "",
  s_desc = ""
)

Arguments

cytox	The toxicity dataset containing multiple observations per patient with one observation per AE > grade 0
id	The patient ID variable used in the dataset
byvar	Variable used to separate summary by arm. If not present, "All Patients" printed for arm
grade.term	Character. The variable that contains the AE grade
relation.term	Character. The variable that containst the AE attribution
tox.term	Character. The variable that contains the toxicity (MEDRA) code
prot_num	The study protocol number. Found in protref$dc_num
s_desc	Short description of the study. Found in protref$s_desc.

Value

This function returns a list of 1: Protocol Number and evaluable patients per Arm as a string, 2: Summary AE table, and 3: Total number of evaluable patients.

Author(s)

Sawyer Jacobson

Adam Pettinger

Examples

#With data loaded for A041501

crtlibn(d = 'A041501')

irb.summary <- irbtox_summary(cytox = cytox, id = "dcntr_id", byvar = "arm", tox.term = "toxicity",
 prot_num = protref$dc_num, s_desc = protref$shrt_ttl_m)
irb.summary$table

sjacobson94/clinicaltrials documentation built on Oct. 27, 2020, 6:43 p.m.