Listing 3: ORR

Objective Response Rate (ORR)

This page summarizes ORR (CR + PR) with supporting traceability (programs → outputs).

What you’ll find here

  • Endpoint: ORR = % of subjects with confirmed BOR = CR or PR (per protocol/RECIST)
  • Population: ITT (or mITT / response-evaluable — define explicitly)
  • Display: n/N (%) with Exact (Clopper–Pearson) 95% CI (and treatment comparison if applicable)

Deliverables

Traceability

Table → ADRS (Response) → SDTM RS/TR/TU → Source

Key variables (typical)

  • Response: BOR, CONFIRMFL (or confirmation rule variable), BORADT
  • Analysis flags: ITTFL, EFFFL (or response-evaluable flag)
  • Treatment: TRT01A

Notes

  • Specify RECIST version, confirmation window/rule, and cut-off date in the footnote.
  • Define handling of missing/unevaluable assessments (often non-responder unless specified).