Intercurrent-event strategy map =============================== StatMedAnalysis | Original downloadable worksheet | 6 November 2026 Connect post-baseline events to the treatment-effect question. How to use this worksheet List events that affect interpretation or existence of the outcome, distinguishing them from missing observations. For each event, state the scientific question and selected estimand strategy. Identify the data required after the event and the estimation assumptions. Check compatibility among endpoint, strategy and summary measure. Save a working copy and keep the original blank version. Use public, hypothetical or aggregate information only; do not enter patient identifiers, credentials or confidential records. Keep source evidence in your approved project workspace. Mark unresolved text fields UNKNOWN or NOT REPORTED with a reason; never substitute zero for an unknown count. Project/version __________________ Prepared by role/date __________________ Working fields 1. Treatment contrast and population Response/evidence: _________________________________________________________ ___________________________________________________________________________ 2. Endpoint and summary measure Response/evidence: _________________________________________________________ ___________________________________________________________________________ 3. Intercurrent event definition Response/evidence: _________________________________________________________ ___________________________________________________________________________ 4. Strategy and clinical rationale Response/evidence: _________________________________________________________ ___________________________________________________________________________ 5. Required post-event observations Response/evidence: _________________________________________________________ ___________________________________________________________________________ 6. Missing-data implications Response/evidence: _________________________________________________________ ___________________________________________________________________________ 7. Estimator and identifying assumptions Response/evidence: _________________________________________________________ ___________________________________________________________________________ 8. Sensitivity or supplementary analysis Response/evidence: _________________________________________________________ ___________________________________________________________________________ Hypothetical worked case A fictional trial measures symptom score at week 12, but some participants die before then. A post-death symptom value does not exist; choosing an estimand strategy requires a meaningful question rather than imputing a routine missing score. Decision rule and limitations Approve the analysis only when the estimand attributes and estimator are compatible. An analysis-population label alone does not specify an intercurrent-event strategy. Decision _______________________ Remaining uncertainty ____________________ Next action ____________________ Owner / review date ______________________ Independent check and discrepancy resolution _______________________________ Official method or reporting reference checked 6 November 2026 https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf This is an original planning aid, not an official checklist, validated instrument, clinical recommendation or certificate of expert approval. Apply the referenced guidance to the specific design and record any additional requirements.