dsmb_ddp: Outputs the DSMB-DDP AE summary tables in Excel format per...
In BiostatsUHNplus: Nested Data Summary, Adverse Events and REDCap

dsmb_ddp

R Documentation

Outputs the DSMB-DDP AE summary tables in Excel format per UHN template

Description

Outputs the DSMB-DDP AE summary tables in Excel format per UHN template

Usage

dsmb_ddp(
  protocol,
  setwd,
  title,
  comp = NULL,
  pi,
  presDate,
  cutDate,
  boundDate = NULL,
  subjID,
  subjID_ineligText = NULL,
  baseline_datasets,
  ae_dataset,
  ineligVar = NULL,
  ineligVarText = NULL,
  genderVar,
  enrolDtVar,
  ae_detailVar,
  ae_categoryVar = NULL,
  ae_severityVar,
  ae_onsetDtVar,
  ae_detailOtherText = NULL,
  ae_detailOtherVar = NULL,
  ae_verbatimVar = NULL,
  ae_attribVars = NULL,
  ae_attribVarsName = NULL,
  ae_attribVarText = NULL,
  related_ae = FALSE,
  numSubj = NULL,
  fileNameUnderscore = TRUE
)

Arguments

`protocol`	study protocol name (uppercase, no spaces permitted)
`setwd`	directory to write Excel summary files to
`title`	full character vector with name of study
`comp`	baseline comparison group. For example, cohort (if provided)
`pi`	character vector name of study principal investigator
`presDate`	presentation date (i.e. 17NOV2023) for DSMB
`cutDate`	recent cutoff date for AEs (i.e. 31AUG2023)
`boundDate`	lower bound cutoff date for AEs (if provided)
`subjID`	key identifier field for participant ID in data sets
`subjID_ineligText`	character text that denotes participant IDs to exclude. For example, c("New Subject") (if provided)
`baseline_datasets`	list of data frames that contain baseline participant characteristics. For example, list(enrollment_DF,demography_DF,ineligibility_DF)
`ae_dataset`	data frame that contains subject AEs
`ineligVar`	field that denotes participant ineligibility (if provided)
`ineligVarText`	character text that denotes participant ineligibility. For example, c("Yes", "Y") (if provided)
`genderVar`	field that denotes participant gender
`enrolDtVar`	field that denotes participant enrollment date (i.e. 10MAY2021)
`ae_detailVar`	field that denotes participant AE detail (lowest level term)
`ae_categoryVar`	field that denotes participant AE category (system organ class)
`ae_severityVar`	field that denotes participant AE severity grade (numeric)
`ae_onsetDtVar`	field that denotes participant AE onset date
`ae_detailOtherText`	character text that denotes referencing verbatim AE field. For example, c("Other, specify", "OTHER") (if provided)
`ae_detailOtherVar`	field that denotes participant AE detail other (if provided)
`ae_verbatimVar`	field that denotes participant AE detail verbatim (if provided)
`ae_attribVars`	field(s) that denotes attribution to intervention under study. For example, c("CTC_AE_ATTR_SCALE","CTC_AE_ATTR_SCALE_1") (if provided)
`ae_attribVarsName`	character text that denotes name of interventions under study. For example, c("Drug 1", "Drug 2") (if provided)
`ae_attribVarText`	character text that denotes related attribution. For example c("Definite", "Probable", "Possible") (if provided)
`related_ae`	boolean that denotes if summary is for related AEs. Default is False.
`numSubj`	vector to override value for number of participants in summary (if provided)
`fileNameUnderscore`	boolean that denotes if spaces should be underscore in filename

Value

three Excel files containing DSMB-CCRU AE summary tables

Examples

data("enrollment", "demography", "ineligibility", "ae");
dsmb_ddp(protocol="EXAMPLE_STUDY",setwd="./man/tables/",
  title="Phase X Study to Evaluate Treatments A-D",
  comp="COHORT",pi="Dr. Principal Investigator",
  presDate="30OCT2020",cutDate="31AUG2020",
  boundDate=NULL,subjID="Subject",subjID_ineligText=c("New Subject","Test"),
  baseline_datasets=list(enrollment,demography,ineligibility),
  ae_dataset=ae,ineligVar="INELIGIBILITY_STATUS",ineligVarText=c("Yes","Y"),
  genderVar="GENDER_CODE",enrolDtVar="ENROL_DATE_INT",ae_detailVar="ae_detail",
  ae_categoryVar="ae_category",ae_severityVar="AE_SEV_GD",
  ae_onsetDtVar="AE_ONSET_DT_INT",ae_detailOtherText="Other, specify",
  ae_detailOtherVar="CTCAE5_LLT_NM",ae_verbatimVar="AE_VERBATIM_TRM_TXT",
  ae_attribVars=c("CTC_AE_ATTR_SCALE","CTC_AE_ATTR_SCALE_1"),
  ae_attribVarsName=c("Drug 1","Drug 2"),
  ae_attribVarText=c("Definite", "Probable", "Possible"),
  numSubj=c(4,4,3,4))

BiostatsUHNplus documentation built on Sept. 10, 2025, 5:08 p.m.