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Bug: derive_var_atoxgr_dir() derives baseline CTCAE grade relative to baseline (if baseline abnormal) #2512
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Thanks @MChiabudini for your feedback! :) @millerg23 do you mind taking a look at this please? I actually thought we took this into consideration when making this function. |
These lab tests are problematic with the way the criteria is worded. However I think we are being conservative here, as if BASELINE was abnormal, and we graded the BASELINE as grade 1 (as we compared with ULN), and then say at Visit 1, the lab value was exactly the same, it would be graded 0, which may give impression that the treatment has made a difference to the grade, when in fact the lab value remained the same after treatment. |
Should we note this in the function documentation and recommended a way to address? |
I agree on that. Also to me it seems odd to grade an unchanged post-baseline value with grade 0 if BASELINE was graded as grade 1. |
@millerg23 did we address this issue already or does this still need to be addressed? |
@MChiabudini apologies for not responding to your follow-up question. I believe a new table shell was created where they reported baseline using ANRIND, so HIGH, LOW, NORMAL, (instead of baseline grade) and then displayed the grade for post-baseline values. |
What happened?
In CTCAE v5 some lab parameters are graded relative to baseline if baseline was abnormal (e.g., Alanine aminotransferase increased, CTCAE grade 1: >ULN - 3.0 x ULN if baseline was normal; 1.5 - 3.0 x baseline if baseline was abnormal). In
derive_var_atoxgr_dir()
this definition is also applied to the baseline value itself, resulting in baseline CTCAE grade being always 0 for such lab parameters.From my perspective, only post-baseline values should be graded using baseline as reference (if baseline was abnormal). All baseline (or also pre-baseline) values should be graded based on normal ranges only, irrespective whether baseline was normal or abnormal.
For example, the following baseline values for alanine aminotransferase should be graded with grade 1, and not grade 0 (compare reprex below):
Session Information
R version 4.2.2 (2022-10-31 ucrt)
Platform: x86_64-w64-mingw32/x64 (64-bit)
Running under: Windows 10 x64 (build 19045)
Matrix products: default
locale:
[1] LC_COLLATE=English_United States.utf8 LC_CTYPE=English_United States.utf8 LC_MONETARY=English_United States.utf8 LC_NUMERIC=C LC_TIME=English_United States.utf8
attached base packages:
[1] stats graphics grDevices utils datasets methods base
other attached packages:
[1] stringr_1.5.1 lubridate_1.9.3 dplyr_1.1.4 pharmaversesdtm_1.0.0 admiral_1.1.0 devtools_2.4.5 usethis_2.1.6
loaded via a namespace (and not attached):
[1] Rcpp_1.0.12 compiler_4.2.2 pillar_1.9.0 later_1.3.2 urlchecker_1.0.1 profvis_0.3.7 remotes_2.5.0 tools_4.2.2 digest_0.6.35 pkgbuild_1.4.4 pkgload_1.3.4 timechange_0.3.0
[13] memoise_2.0.1 lifecycle_1.0.4 tibble_3.2.1 admiraldev_1.1.0 pkgconfig_2.0.3 rlang_1.1.4 shiny_1.7.4 cli_3.6.2 rstudioapi_0.14 fastmap_1.2.0 withr_3.0.0 hms_1.1.3
[25] generics_0.1.3 fs_1.6.4 vctrs_0.6.5 htmlwidgets_1.6.4 tidyselect_1.2.1 glue_1.7.0 R6_2.5.1 fansi_1.0.6 sessioninfo_1.2.2 tidyr_1.3.1 purrr_1.0.2 magrittr_2.0.3
[37] promises_1.3.0 ellipsis_0.3.2 htmltools_0.5.8.1 mime_0.12 xtable_1.8-4 httpuv_1.6.8 utf8_1.2.4 stringi_1.8.4 miniUI_0.1.1.1 cachem_1.1.0
Reproducible Example
Run ADLB template included in
{admiral}
up to line 258, change line 266 tograde_crit <- atoxgr_criteria_ctcv5
, and then run lines 269 to 312:Check baseline ATOXGRH for baseline values above ULN for lab parameters where CTCAE grading is relative to baseline in case baseline was abnormal, e.g. Alanine aminotransferase increased
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