generated from pharmaverse/admiraltemplate
-
Notifications
You must be signed in to change notification settings - Fork 2
Commit
This commit does not belong to any branch on this repository, and may belong to a fork outside of the repository.
Merge pull request #74 from pharmaverse/4_vx_test_data
Closes #4 Add vaccines test data
- Loading branch information
Showing
38 changed files
with
2,156 additions
and
4 deletions.
There are no files selected for viewing
This file contains bidirectional Unicode text that may be interpreted or compiled differently than what appears below. To review, open the file in an editor that reveals hidden Unicode characters.
Learn more about bidirectional Unicode characters
This file contains bidirectional Unicode text that may be interpreted or compiled differently than what appears below. To review, open the file in an editor that reveals hidden Unicode characters.
Learn more about bidirectional Unicode characters
This file contains bidirectional Unicode text that may be interpreted or compiled differently than what appears below. To review, open the file in an editor that reveals hidden Unicode characters.
Learn more about bidirectional Unicode characters
This file contains bidirectional Unicode text that may be interpreted or compiled differently than what appears below. To review, open the file in an editor that reveals hidden Unicode characters.
Learn more about bidirectional Unicode characters
This file contains bidirectional Unicode text that may be interpreted or compiled differently than what appears below. To review, open the file in an editor that reveals hidden Unicode characters.
Learn more about bidirectional Unicode characters
Original file line number | Diff line number | Diff line change |
---|---|---|
@@ -0,0 +1,219 @@ | ||
# 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) |
Oops, something went wrong.