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#276 crpr: add more details
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bundfussr committed Jan 23, 2025
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14 changes: 8 additions & 6 deletions vignettes/adrs.Rmd
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Expand Up @@ -30,12 +30,14 @@ implementing other response criteria than RECIST 1.1, e.g., iRECIST or
International Myeloma Working Group (IMWG) criteria for the diagnosis of
multiple myeloma.

The case that `CR` is followed by `PR` (or `SD`) is considered as a data issue
and the derivations of the parameters don't handle this case specially. It is
recommended to fix the issue in the source data, e.g., by changing the `PR` to
`PD` rather than handling it in the parameter derivations. This ensures
consistency across parameters. However, `admiral::derive_extreme_event()` is so
flexible that it is possible to handle it in the parameter derivations.
For confirmation of response particularly, `CR`, the case that `CR` is followed
by `PR` (or `SD`) is considered as a data issue and the derivations of the
parameters don't handle this case specially. It is recommended to fix the issue
in the source data, e.g., by changing the `PR` to `PD` rather than handling it
in the parameter derivations. This ensures consistency across parameters.
However, `admiral::derive_extreme_event()` is so flexible that it is possible to
handle it in the parameter derivations, for example, by redefining the `bor_pr`
event and adding an additional `PD` event.

Examples are currently presented and tested using `ADSL` (ADaM) and
`RS`, `TU` (SDTM) inputs. However, other domains could be used. The
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16 changes: 9 additions & 7 deletions vignettes/adrs_basic.Rmd
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Expand Up @@ -23,13 +23,15 @@ This article describes creating an `ADRS` ADaM with common oncology endpoint
parameters based on RECIST v1.1. Therefore response values are expected as
either `CR`, `PR`, `SD`, `NON-CR/NON-PD`, `PD` or `NE`.

The case that `CR` is followed by `PR` (or `SD`) is considered as a data issue
and the derivations of the parameters don't handle this case specially. The
`{admiralonco}` functions don't provide functionality to handle this case. It is
recommended to fix the issue in the source data, e.g., by changing the `PR` to
`PD` rather than handling it in the parameter derivations. This ensures
consistency across parameters. The functions `derive_param_confirmed_bor()` and
`derive_param_confirmed_resp()` issue a warning if `CR` is followed by `PR`.
For confirmation of response particularly, `CR`, the case that `CR` is followed
by `PR` (or `SD`) is considered as a data issue and the derivations of the
parameters don't handle this case specially. The `{admiralonco}` functions don't
provide functionality to handle this case. It is recommended to fix the issue in
the source data, e.g., by changing the `PR` to `PD` rather than handling it in
the parameter derivations. This ensures consistency across parameters. The
functions `derive_param_confirmed_bor()` and `derive_param_confirmed_resp()`
issue a warning if `CR` is followed by `PR` (the warning does not display if
`CR` is followed by `SD`).

Please note that this vignette describes the endpoints which were considered by
the admiralonco team as the most common ones. The admiralonco functions used to
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