aeReport2: Report Summarizing All Adverse Events

Description Usage Arguments Details Side Effects See Also Examples

Description

This report uses a data format in which records exist only for events, and these events are classified as major and minor events. Typically major refers to organ system and minor to preferred term. As only events are signaled in the data, the denominator (number of subjects at risk and having some likelihood of having had adverse events collected had they occured) for each treatment must be specified. Produces an open meeting table not stratified by treatment (for open report) and one stratified by treatment (for closed report) in the gentex directory.

Usage

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  aeReport2(major, minor = rep("", length(major)), treat,
    id, denom, panel = "ae",
    caption = "Summary of adverse events by system organ class and preferred term",
    ncaption = "",
    descending = c("both", "major", "minor", "none"),
    sortby = c("incidence", "% difference"),
    headerStr = "AE", minpct = c(0, 0), mindif = c(0, 0),
    size = NULL, longtable = FALSE, lines.page = 50,
    landscape = FALSE, maxcol = NULL, append = FALSE,
    ref.label = NULL, minfreq = 7, major.filter = TRUE,
    minor.filter = FALSE, appendix = TRUE)

Arguments

major

factor or character vector specifying the major classification of events, usually organ system

minor

factor or character vector specifying the minor classification, usually an individual event given by the preferred term. If minor is omitted, breakdowns are only by major.

treat

discrete treatment variable

id

subject ID, used to determine when multiple events arise from the same subject

denom

a vector giving the number of subjects on each treatment (in order of treatment levels), i.e., number of subjects at risk

panel

base name for .tex files. Default is "ae". Table for the open report has an "O" put at the front, and files are written to directory gentex.

caption

text string containing the table caption. Other information is automatically appended to this, especially related to minpct and mindif. caption should not end with a period.

ncaption

NEEDDOC

descending

By default, major categories are sorted in order of descending frequency (ignoring minor), and minor categories are sorted in order of descending frequency within each major category. Specify descending='none' to have categories in order of factor levels or alphabetic for character variables, or to 'major' or 'minor'.

sortby

Specify sortby='% difference' to have descending apply to difference in percent incidence between two treatments, instead of to the pooled incidence over treatments. For the open report, sorting is always alphabetic by category or by descending pooled (over treatments) incidence.

headerStr

NEEDDOC

minpct

a 2-vector specifying the minimum percents for which to output results for major and minor categories, respectively. The default is c(0,0) so that all results are output. Specify minpct=c(10,0) for example to only print major categories for which at least a ten percent incidence of events in those categories are present, ignoring treat, and for any qualifying major category, output all minor ones. The percents pertain to the per-subject incidences, not counting multiple events per subject.

mindif

a 2-vector specifying the minimum difference in percent per-subject incidence between treatments, corresponding to major and minor. The sign of differences is ignored. This only applies to the case of two treatments. Output not meeting the minimum difference in percents is suppressed.

size

see latex.default

longtable

see latex.default

lines.page

see latex.default

landscape

passed to latex.default

maxcol

the maximum number of columns to allow for a major or minor label (note that two extra spaces are added to minor labels as they are indented). Longer event labels are wrapped to multiple lines. By default, LaTeX will attempt to display the full labels no matter how long.

append

set to TRUE to have LaTeX code appended to existing files

ref.label

NEEDDOC

minfreq

NEEDDOC

major.filter

NEEDDOC

minor.filter

NEEDDOC

appendix

NEEDDOC

Details

Values of minor are not assumed to be unique across values of major.

Side Effects

creates or appends to files "gentex/Ox.tex" and "gentex/x.tex" under the current working directory, where x is the value of panel.

See Also

aeReport

Examples

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## Not run: 
major <- c('A', 'A', 'A', 'B', 'B', 'C')
minor <- c('a1','a1','a2','b1','b2','c1')
id <- c(1, 1, 1, 1, 2, 3)
treat <- c('drug','placebo','drug','placebo','drug','placebo')
aeReport2(major, minor, treat, id, denom=c(placebo=10,drug=10))
aeReport2(major, minor, treat, id, denom=c(placebo=10,drug=10),
          sortby='% difference')

## End(Not run)

harrelfe/rreport documentation built on May 17, 2019, 2:48 p.m.