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#294 gcig_vignette: style file
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bundfussr committed Nov 25, 2024
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1 change: 1 addition & 0 deletions inst/WORDLIST
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Expand Up @@ -62,4 +62,5 @@ rda
rds
responder
responders
styler
timepoint
4 changes: 4 additions & 0 deletions vignettes/adrs_gcig.Rmd
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Expand Up @@ -91,6 +91,7 @@ For this vignette we made assumptions that following information is collected on
2. The date of CA-125 response is assigned to the date of the first measurement when the CA-125 level is reduced by 50%. The date of CA-125 progression is assigned to the date of the first measurement that meets progression criteria. This is assumed to be collected on the CRF CA-125 response page.
3. CA-125 responses are mapped to `CR`, `PR`, `SD`, `PD`, `NE` as shown below.
```{r echo=FALSE}
# styler: off
list_resp <- tibble::tribble(
~"CA-125 response per GCIG", ~"CA-125 response mapped",
"Response within Normal Range", "CR",
Expand All @@ -101,12 +102,14 @@ For this vignette we made assumptions that following information is collected on
)

knitr::kable(list_resp)
# styler: on
```

4. Combined CA-125 and RECIST 1.1 response per visit where both RECIST 1.1 and CA-125 is evaluated is also collected on the CRF. The investigator should already consider CA-125 confirmed response and each visit RECIST 1.1 response based on GCIG document.
5. In `SUPPRS` there are records with below `QNAM` and `QLABEL` values:

```{r echo=FALSE}
# styler: off
list_supp <- tibble::tribble(
~"QNAM", ~"QLABEL", ~"QVAL", ~"Purpose", ~"Use case",
"`CA125EFL`", "CA-125 response evaluable", "Y/N", "Indicates population evaluable for CA-125 response (baseline CA-125 >= 2 * ULRR and no mouse antibodies)", "`CA125EFL` variable",
Expand All @@ -118,6 +121,7 @@ For this vignette we made assumptions that following information is collected on
)
knitr::kable(list_supp)
# styler: on
```
If the data are collected by other ways and similar information from `SUPPRS` dataset are not available, they should be derived in advance from `LB` CA-125 measurements records. Information on whether the patient has received mouse antibodies should also be taken into account.
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