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Merge pull request #74 from pharmaverse/4_vx_test_data
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Closes #4 Add vaccines test data
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manciniedoardo authored Oct 19, 2023
2 parents 311be20 + a861424 commit b106d41
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4 changes: 2 additions & 2 deletions .github/workflows/common.yml
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- "v*"
branches:
- main
- devel
- patch
# 'pull_request' events are triggered when PRs are
# created against one of these target branches.
pull_request:
branches:
- main
- devel
- patch
# 'release' events are triggered when...
# you guessed it - when releases are made.
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check:
name: Check
uses: pharmaverse/admiralci/.github/workflows/r-cmd-check.yml@main
with:
error-on: warning # TODO: find a way to ignore specific notes
if: github.event_name == 'pull_request'
docs:
name: Documentation
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2 changes: 1 addition & 1 deletion DESCRIPTION
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@@ -1,7 +1,7 @@
Package: pharmaversesdtm
Type: Package
Title: Test Data for the Pharmaverse Family of Packages
Version: 0.1.1
Version: 0.1.1.9000
Authors@R: c(
person("Edoardo", "Mancini", email = "edoardo.mancini@roche.com", role = c("aut", "cre")),
person("Gayatri", "G", role = "aut"),
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17 changes: 17 additions & 0 deletions NEWS.md
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@@ -1,3 +1,20 @@
# pharmaversesdtm (development version)

## New Features

Following Vaccine Specific SDTM datasets have been added. (#4)

- `ce_vaccine`
- `dm_vaccine`
- `ex_vaccine`
- `face_vaccine`
- `is_vaccine`
- `vs_vaccine`
- `suppce_vaccine`
- `suppdm_vaccine`
- `suppex_vaccine`
- `suppface_vaccine`

# pharmaversesdtm 0.1.1

## Documentation
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77 changes: 77 additions & 0 deletions R/data.R
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#'
#' @source \url{https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/sv.xpt?raw=true} # nolint
"sv"

#' Demographics Dataset for Vaccine Studies
#'
#' An example SDTM DM dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_dm.rda} # nolint
"dm_vaccine"

#' Vital Signs Dataset for Vaccine Studies
#'
#' An example SDTM VS dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_vs.rda} # nolint
"vs_vaccine"

#' Clinical Events Dataset for Vaccine Studies
#'
#' An example SDTM CE dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_ce.rda} # nolint
"ce_vaccine"

#' Exposures Dataset for Vaccine Studies
#'
#' An example SDTM EX dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_ex.rda} # nolint
"ex_vaccine"

#' Immunogenicity Specimen Assessments Dataset for Vaccine Studies
#'
#' An example SDTM IS dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_is.rda} # nolint
"is_vaccine"

#' Findings About Clinical Events Dataset for Vaccine Studies
#'
#' An example SDTM FACE dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_face.rda} # nolint
"face_vaccine"

#' Supplemental Qualifiers for Clinical Events Dataset for Vaccine Studies
#'
#' An example SDTM SUPPCE dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_suppce.rda} # nolint
"suppce_vaccine"

#' Supplemental Qualifiers for Demographics Dataset for Vaccine Studies
#'
#' An example SDTM SUPPDM dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_suppdm.rda} # nolint
"suppdm_vaccine"

#' Supplemental Qualifiers for Exposures Dataset for Vaccine Studies
#'
#' An example SDTM SUPPEX dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_suppex.rda} # nolint
"suppex_vaccine"

#' Supplemental Qualifiers for Findings About for Clinical Events Dataset for Vaccine Studies # nolint
#'
#' An example SDTM SUPPFACE dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_suppface.rda} # nolint
"suppface_vaccine"

#' Supplemental Qualifiers for Immunogenicity Specimen Assessments Dataset for Vaccine Studies # nolint
#'
#' An example SDTM SUPPIS dataset for vaccine studies
#'
#' @source \url{https://github.com/pharmaverse/admiralvaccine/blob/main/data/vx_suppis.rda} # nolint
"suppis_vaccine"
219 changes: 219 additions & 0 deletions data-raw/ce_vaccine.R
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# Dataset: ce_vaccine
# Description: CE test SDTM dataset for Vaccine studies


# Load libraries ----

library(tibble)
library(dplyr)
library(tidyr)
library(metatools)

# Create CE

## Create a dummy CE dataset

ce_t <- tribble(
~STUDYID, ~DOMAIN, ~USUBJID, ~CESEQ, ~CETERM, ~CEDECOD, ~CELAT, ~CELOC, ~CEPRESP, ~CEOCCUR,
~CESEV, ~CEREL, ~CEOUT, ~EPOCH, ~CEDTC, ~CESTDTC, ~CEENDTC, ~CEDUR, ~CETPTREF, ~CERFTDTC,
~CEEVINTX, ~CESTAT, ~CEREASND,
"ABC", "CE", "ABC-1001", 1, "CHILLS", "Chills", NA,
NA, "Y", "N", NA, NA, NA, NA,
NA, NA, NA, NA, "VACCINATION 1", "2021-11-03T10:50:00",
"SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 2, "PAIN AT INJECTION SITE", "Injection site pain",
"LEFT", "DELTOID MUSCLE", "Y", "Y", "MODERATE", "RELATED", "RECOVERED/RESOLVED",
"VACCINATION 1", "2021-11-09", "2021-11-04", "2021-11-07", "P4D", "VACCINATION 1",
"2021-11-03T10:50:00", "SINCE VACCINATION", NA,
NA,
"ABC", "CE", "ABC-1001", 3, "REDNESS", "Erythema", "LEFT",
"DELTOID MUSCLE", "Y", "Y", "MODERATE", "RELATED", "RECOVERED/RESOLVED",
"VACCINATION 1", "2021-11-06", "2021-11-04", "2021-11-04", "P1D", "VACCINATION 1",
"2021-11-03T10:50:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 4, "SWELLING", "Swelling",
"LEFT", "DELTOID MUSCLE", "Y", "Y", "MODERATE", "RELATED", "RECOVERED/RESOLVED",
"VACCINATION 1", "2021-11-11", "2021-11-03", "2021-11-09", "P7D", "VACCINATION 1",
"2021-11-03T10:50:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 5, "DIARRHEA", "Diarrhoea", NA,
NA, "Y", "N", NA, NA, NA, NA,
NA, NA, NA, NA, "VACCINATION 1", "2021-11-03T10:50:00",
"SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 6, "FATIGUE", "Fatigue", NA,
NA, "Y", "Y", "MILD", "RELATED", "RECOVERED/RESOLVED", "VACCINATION 1",
"2021-11-06", "2021-11-03", "2021-11-04", "P2D", "VACCINATION 1",
"2021-11-03T10:50:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 7, "FEVER", "Pyrexia", NA,
NA, "Y", "N", NA, NA, NA, NA,
NA, NA, NA, NA, "VACCINATION 1", "2021-11-03T10:50:00",
"SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 8, "HEADACHE", "Headache", NA,
NA, "Y", "N", NA, NA, NA, NA,
NA, NA, NA, NA, "VACCINATION 1", "2021-11-03T10:50:00",
"SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 9, "NEW OR WORSENED JOINT PAIN",
"Arthralgia", NA, NA, "Y", "Y", "MILD", "RELATED",
"RECOVERED/RESOLVED", "VACCINATION 1", "2021-11-06", "2021-11-04", "2021-11-04",
"P1D", "VACCINATION 1", "2021-11-03T10:50:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 10, "NEW OR WORSENED MUSCLE PAIN",
"Myalgia", NA, NA, "Y", "Y", "MILD", "RELATED",
"RECOVERED/RESOLVED", "VACCINATION 1", "2021-11-06", "2021-11-04", "2021-11-04",
"P1D", "VACCINATION 1", "2021-11-03T10:50:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 11, "VOMITING", "Vomiting", NA,
NA, "Y", "N", NA, NA, NA, NA,
NA, NA, NA, NA, "VACCINATION 1", "2021-11-03T10:50:00",
"SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1001", 12, "CHILLS", "Chills", NA, NA,
"Y", NA, NA, NA, NA, NA,
NA, NA, NA, NA, "VACCINATION 2", "2021-12-30T09:10:00",
"SINCE VACCINATION", "NOT DONE", "SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 13, "PAIN AT INJECTION SITE", "Injection site pain",
"LEFT", "DELTOID MUSCLE", "Y", NA, NA, NA,
NA, NA, NA, NA, NA, NA,
"VACCINATION 2", "2021-12-30T09:10:00", "SINCE VACCINATION", "NOT DONE",
"SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 14, "REDNESS", "Erythema", "LEFT",
"DELTOID MUSCLE", "Y", NA, NA, NA, NA,
NA, NA, NA, NA, NA, "VACCINATION 2",
"2021-12-30T09:10:00", "SINCE VACCINATION", "NOT DONE",
"SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 15, "SWELLING", "Swelling", "LEFT",
"DELTOID MUSCLE", "Y", NA, NA, NA, NA,
NA, NA, NA, NA, NA, "VACCINATION 2",
"2021-12-30T09:10:00", "SINCE VACCINATION", "NOT DONE",
"SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 16, "DIARRHEA", "Diarrhoea", NA,
NA, "Y", NA, NA, NA, NA, NA,
NA, NA, NA, NA, "VACCINATION 2", "2021-12-30T09:10:00",
"SINCE VACCINATION", "NOT DONE", "SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 17, "FATIGUE", "Fatigue", NA,
NA, "Y", NA, NA, NA, NA, NA,
NA, NA, NA, NA, "VACCINATION 2", "2021-12-30T09:10:00",
"SINCE VACCINATION", "NOT DONE", "SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 18, "FEVER", "Pyrexia", NA,
NA, "Y", NA, NA, NA, NA, NA,
NA, NA, NA, NA, "VACCINATION 2", "2021-12-30T09:10:00",
"SINCE VACCINATION", "NOT DONE", "SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 19, "HEADACHE", "Headache", NA, NA, "Y", NA, NA, NA, NA, NA, NA, NA, NA,
NA, "VACCINATION 2", "2021-12-30T09:10:00", "SINCE VACCINATION", "NOT DONE",
"SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 20, "NEW OR WORSENED JOINT PAIN", "Arthralgia", NA, NA, "Y", NA, NA, NA,
NA, NA, NA, NA, NA, NA, "VACCINATION 2", "2021-12-30T09:10:00", "SINCE VACCINATION", "NOT DONE",
"SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 21, "NEW OR WORSENED MUSCLE PAIN", "Myalgia", NA, NA, "Y", NA, NA, NA,
NA, NA, NA, NA, NA, NA, "VACCINATION 2", "2021-12-30T09:10:00", "SINCE VACCINATION", "NOT DONE",
"SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1001", 22, "VOMITING", "Vomiting", NA, NA, "Y", NA, NA, NA, NA, NA, NA, NA, NA,
NA, "VACCINATION 2", "2021-12-30T09:10:00", "SINCE VACCINATION", "NOT DONE",
"SUBJECT DID NOT COMPLETE ELECTRONIC DIARY",
"ABC", "CE", "ABC-1002", 1, "CHILLS", "Chills", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA, NA, NA,
"VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 2, "PAIN AT INJECTION SITE", "Injection site pain", "LEFT",
"DELTOID MUSCLE", "Y", "N", NA, NA, NA, NA, NA, NA, NA, NA, "VACCINATION 1",
"2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 3, "REDNESS", "Erythema", "LEFT", "DELTOID MUSCLE",
"Y", "Y", "MILD", "RELATED", "RECOVERED/RESOLVED", "VACCINATION 1", "2021-10-11", "2021-10-09",
"2021-10-09", "P1D", "VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 4, "SWELLING", "Swelling", "LEFT", "DELTOID MUSCLE", "Y", "N", NA,
NA, NA, NA, NA, NA, NA, NA, "VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 5, "DIARRHEA", "Diarrhoea", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA, NA,
NA, "VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 6, "FATIGUE", "Fatigue", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA, NA,
NA, "VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 7, "FEVER", "Pyrexia", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA, NA, NA,
"VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 8, "HEADACHE", "Headache", NA, NA, "Y", "Y", "MODERATE", "RELATED",
"RECOVERED/RESOLVED", "VACCINATION 1", "2021-10-13", "2021-10-11", "2021-10-11", "P1D",
"VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 9, "NEW OR WORSENED JOINT PAIN", "Arthralgia", NA, NA, "Y", "N", NA, NA,
NA, NA, NA, NA, NA, NA, "VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 10, "NEW OR WORSENED MUSCLE PAIN", "Myalgia", NA, NA, "Y", "N", NA, NA,
NA, NA, NA, NA, NA, NA, "VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 11, "VOMITING", "Vomiting", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA, NA,
NA, "VACCINATION 1", "2021-10-07T12:48:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 12, "CHILLS", "Chills", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA, NA, NA,
"VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 13, "PAIN AT INJECTION SITE", "Injection site pain", "LEFT",
"DELTOID MUSCLE", "Y", "Y", "MILD", "RELATED", "RECOVERED/RESOLVED", "VACCINATION 2",
"2021-12-21", "2021-12-16", "2021-12-19", "P4D", "VACCINATION 2", "2021-12-16T12:41:00",
"SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 14, "REDNESS", "Erythema", "LEFT", "DELTOID MUSCLE", "Y", "Y", "MILD",
"RELATED", "RECOVERED/RESOLVED", "VACCINATION 2", "2021-12-23", "2021-12-17", "2021-12-21", "P5D",
"VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 15, "SWELLING", "Swelling", "LEFT", "DELTOID MUSCLE", "Y", "Y", "MILD",
"RELATED", "RECOVERED/RESOLVED", "VACCINATION 2", "2021-12-21", "2021-12-17", "2021-12-19", "P3D",
"VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 16L, "DIARRHEA", "Diarrhoea", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA,
NA, NA, "VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 17L, "FATIGUE", "Fatigue", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA, NA,
NA, "VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 18L, "FEVER", "Pyrexia", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA, NA,
NA, "VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 19L, "HEADACHE", "Headache", NA, NA, "Y", "Y", "MILD", "RELATED",
"RECOVERED/RESOLVED", "VACCINATION 2", "2021-12-23", "2021-12-21", "2021-12-21", "P1D",
"VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 20L, "NEW OR WORSENED JOINT PAIN", "Arthralgia", NA, NA, "Y", "N", NA,
NA, NA, NA, NA, NA, NA, NA, "VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 21L, "NEW OR WORSENED MUSCLE PAIN", "Myalgia", NA, NA, "Y", "N", NA, NA,
NA, NA, NA, NA, NA, NA, "VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA,
"ABC", "CE", "ABC-1002", 22L, "VOMITING", "Vomiting", NA, NA, "Y", "N", NA, NA, NA, NA, NA, NA,
NA, NA, "VACCINATION 2", "2021-12-16T12:41:00", "SINCE VACCINATION", NA, NA
)

## Create final CE dataset ----

vx_ce <- ce_t %>%
mutate(
CELNKGRP = paste(CETPTREF, "-", CETERM),
CECAT = "REACTOGENICITY",
CESCAT = ifelse(is.na(CELAT), "SYSTEMIC", "ADMINISTRATION SITE"),
CETPT = "DAY 7",
CETPTNUM = 7
) %>%
unite(
CELNKID, CETPTREF, CELOC, CELAT, CETERM,
sep = "-", na.rm = TRUE, remove = FALSE
) %>%
select(
STUDYID, DOMAIN, USUBJID, CESEQ, CELNKID, CELNKGRP, CETERM,
CEDECOD, CELAT, CELOC, CECAT, CESCAT, CEPRESP, CEOCCUR, CESEV, CEREL,
CEOUT, EPOCH, CEDTC, CESTDTC, CEENDTC, CEDUR, CETPT, CETPTNUM, CETPTREF,
CERFTDTC, CEEVINTX, CESTAT, CEREASND
)

ce_vaccine <- vx_ce %>% add_labels(
STUDYID = "Study Identifier",
DOMAIN = "Domain Abbreviation",
USUBJID = "Unique Subject Identifier",
CESEQ = "Sequence Number",
CELNKID = "Link ID",
CELNKGRP = "Link Group ID",
CETERM = "Reported Term for the Clinical Event",
CEDECOD = "Dictionary-Derived Term",
CELAT = "Laterality of Location of Clinical Event",
CELOC = "Location of Clinical Event",
CECAT = "Category for Clinical Event",
CESCAT = "Subcategory for Clinical Event",
CEPRESP = "Clinical Event Pre-Specified",
CEOCCUR = "Clinical Event Occurrence",
CESEV = "Severity/Intensity",
CEREL = "Causality",
CEOUT = "Outcome of Clinical Event",
EPOCH = "Epoch",
CEDTC = "Date/Time of Event Collection",
CESTDTC = "Start Date/Time of Clinical Event",
CEENDTC = "End Date/Time of Clinical Event",
CEDUR = "Duration of Clinical Event",
CETPT = "Planned Time Point Name",
CETPTNUM = "Planned Time Point Number",
CETPTREF = "Time Point Reference",
CERFTDTC = "Date/Time of Reference Time Point",
CEEVINTX = "Evaluation Interval Text",
CESTAT = "Completion Status",
CEREASND = "Reason Clinical Event Not Collected"
)

# Label CE dataset ----
attr(ce_vaccine, "label") <- "Clinical Events"

# Save dataset ----
usethis::use_data(ce_vaccine, overwrite = TRUE)
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