aerpt.summary: Create summary of AEs for Alliance DSMB reports

Description Usage Arguments Value Author(s) Examples

View source: R/aerpt.summary.R

Description

This function is design to replicate aerpt_alliance_macro.sas AE summary output for Alliance DSMB reports.

Usage

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aerpt.summary(
  cytox,
  id,
  grade.cutoff = 1,
  rel.cutoff = 0,
  rel.include = 1,
  byvar = "arm",
  arm.include = 1,
  arm.labels = NULL,
  toxvar = "toxicity",
  relvar = "rel_smed",
  gradevar = "grade",
  bodysysvar = "bodysys"
)

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

grade.cutoff

Grade cutoff for minimum AE grade. Inclusive

rel.cutoff

Attribution cutoff for minimum AE attribution. Inclusive

rel.include

Value of 0 or 1. If 0, "Regardless of Attribution" printed in header. If 1, "At least possibly related" printed in header

byvar

Variable used to separate summary by arm. If not present, "All Patients" printed for arm. Set to NULL if calculations are desired for all patients together.

arm.include

Include "Arm" in table (1) or not (0). Default is 1.

arm.labels

Option to include additional Arm labels in the table header. Add as vector of characters.

toxvar

Variable containing numeric toxicity codes.

relvar

Variable containing numeric relation values 1-5.

gradevar

Grade variable, numeric.

bodysysvar

Body system variable, character.

Value

This function creates a summary of the AE events for the Alliance DSMB report

Author(s)

Sawyer Jacobson

Adam Pettinger

Examples

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#With data loaded for A041501

crtlibn(d = 'A041501')

all.summary <- aerpt.summary(cytox, id="dcntr_id", byvar="arm", 
grade.cutoff = 3, rel.cutoff = 0, rel.include = 0)
all.summary$table

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