Skip to contents

`r lifecycle::badge("experimental")`

Filters `dfResults` to flagged patient-level premature-death rows (`MetricID == "Analysis_pat0015"`, `Flag == 2`) and joins `Mapped_Death` detail. Sorted by `death_dy` ascending. `death_reason` is the death classification (`deathcls`), falling back to `"Unknown"` when absent. `treatment_related` is three-valued: `"Yes"` when `deathcls` is an adverse event AND the subject has a fatal (grade 5) treatment-related AE in `dfAE`; `"No"` when `deathcls` is an adverse event AND the subject has a fatal (grade 5) not-treatment-related AE, or when `deathcls` is not an adverse event AND no fatal treatment-related AE exists; `"Unknown"` otherwise (mixed signals, or missing `deathcls`/AE evidence). A `randomization_date` column is derived as `death_dt - death_dy`, reconstructing the randomization date (`rgmn_dt`) that `death_dy` was counted from.

Usage

pd_PatientListingData(
  dfResults,
  dfDeath,
  dfSubjects = NULL,
  dfExclusion = NULL,
  dfAE = NULL
)

Arguments

dfResults

`data.frame` Reporting results containing patient-level rows.

dfDeath

`data.frame` Mapped death data keyed on `subjid`.

dfSubjects

`data.frame` (optional) Mapped subject data with `subjid`, `invid`, and optionally `studyid` / `country`. When supplied, the output includes `studyid` (when present, as the leftmost column), `invid`, and `country` (when present) as visible columns for study-, site-, and country-level filtering in the interactive report.

dfExclusion

`data.frame` (optional) Mapped exclusion data with `subjid` and `Source` (as produced by `EXCLUSION.yaml`). When supplied with a `Source` column, the output gains a three-valued `eligibility_status` column: `"Ineligible"` when `Source != "Neither"` (matching the `kri0014` rule), `"Eligible"` when `Source == "Neither"`, and `"Unknown"` when the subject has no matching exclusion row.

dfAE

`data.frame` (optional) Mapped AE data with `subjid`, `aetoxgr`, and `aerel` (`"RELATED"`/`"NOT RELATED"`). Used to compute the Treatment Related column: `"Yes"` when `deathcls` is an adverse event AND the subject has a fatal (`aetoxgr==5`) treatment-related AE; `"No"` when `deathcls` is an adverse event AND the subject has a fatal (`aetoxgr==5`) not-treatment-related AE, or when `deathcls` is not an AE AND there is no fatal treatment-related AE; `"Unknown"` otherwise (mixed signals, or missing `deathcls`/AE evidence). `death_reason` is `deathcls` (else `"Unknown"`).

Value

A `data.frame` of one row per flagged premature-death subject.