{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "INTERLACE induction carboplatin and paclitaxel · Locally advanced cervical cancer · Evidence checklist for increased five-year overall survival",
  "language": "en",
  "translation_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Existing content review is pending or remains incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "What are the selected question, verdict record and parent context?",
      "needed": "Original question/record and links to parent/related outcomes",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the selected question, verdict record and parent context.",
      "application_exception": "Historical candidate-boundary review pending status is preserved as history; existing content and question-boundary review remain incomplete. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the selected question, verdict record and parent context\" to their original locations. Historical candidate-boundary review pending status is preserved as history; existing content and question-boundary review remain incomplete.",
      "basis": "Own question-specific application conditions informed by the preserved summary and family definition C01.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If new materials for the same question are supplied, link them while preserving the existing record and original wording"
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "How are original subclaim B/note, parent B76 and absent score/axes separated?",
      "needed": "A preserved copy separating the subclaim verdict/note from parent score/axes",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are original subclaim B/note, parent B76 and absent score/axes separated.",
      "application_exception": "A blanket D or the parent's score of 76 and axes are not inherited by the selected subclaim; no new grade or score is created.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are original subclaim B/note, parent B76 and absent score/axes separated\" to their original locations. Direct selected-subclaim score, status and axes values are absent.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If a subclaim correction is actually supplied, record the complete original text, event and change decision separately"
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Do both tables, PFS, OS and safety concern the same trial?",
      "needed": "Relationships among reports, registration, trial families, outcomes/time points and shared populations",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Do both tables, PFS, OS and safety concern the same trial.",
      "application_exception": "The two questions, survival curves, endpoints, centers or 500 participants with 250 per arm are not added as new independent replications or participants.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Do both tables, PFS, OS and safety concern the same trial\" to their original locations. Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If follow-up or other materials are supplied, distinguish shared reports/populations/outcomes from separate families"
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Which preserved summary and external original materials have currently been read?",
      "needed": "Existence, acquisition, reading status and original locations of the preserved summary and external materials",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Which preserved summary and external original materials have currently been read.",
      "application_exception": "Summary reading is not labeled full-text or registry reading, and an access attempt that was not made is not changed to failed access or absent materials.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Which preserved summary and external original materials have currently been read\" to their original locations. External availability/acquisition, current content, link operation and access success were not verified in this work.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C03.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: When obtaining follow-up materials is authorized, record actual reading level and distinguish historical from current dates"
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What were the actual population and selection scope for locally advanced cervical cancer?",
      "needed": "Original eligibility/exclusion, stage and baseline-characteristic tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What were the actual population and selection scope for locally advanced cervical cancer.",
      "application_exception": "Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What were the actual population and selection scope for locally advanced cervical cancer\" to their original locations. Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use materials from the same trial specifying original recruitment conditions, or suitable separate population research"
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What do 32 centers, the international multicenter design and population distribution describe?",
      "needed": "Center/region and recruitment distribution, baseline balance and treatment-delivery materials",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What do 32 centers, the international multicenter design and population distribution describe.",
      "application_exception": "The 32 centers are not labeled independent trials, and no country list or distribution is invented.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What do 32 centers, the international multicenter design and population distribution describe\" to their original locations. Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E01, E07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use supplementary same-trial materials reporting actual regional conditions and results"
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What are the sequence of induction chemotherapy before radiation and the comparator strategy?",
      "needed": "Original protocols, shared treatment, sequencing and delivery for both strategies",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the sequence of induction chemotherapy before radiation and the comparator strategy.",
      "application_exception": "The study sequence is not written as an individual treatment plan, treatment selection or guidance for another sequence.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the sequence of induction chemotherapy before radiation and the comparator strategy\" to their original locations. Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use reports/appendices defining the original comparison of induction addition and standard CCRT"
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "How are nominal induction exposure and actual administered amounts separated?",
      "needed": "Original nominal/actual exposure, changes, adherence, formulation and route materials",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are nominal induction exposure and actual administered amounts separated.",
      "application_exception": "AUC 2 is not converted to mg or mg/kg, and 80 mg/m² is not turned into an individual dose or instructions for use.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are nominal induction exposure and actual administered amounts separated\" to their original locations. Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link actual administration/stopping and results from the same study"
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What was the median interval from induction completion to CCRT?",
      "needed": "Original interval, delay, non-delivery, actual schedule and completion tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What was the median interval from induction completion to CCRT.",
      "application_exception": "The median seven-day interval is not turned into an identical interval for every participant or a recommendation on when to start treatment.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What was the median interval from induction completion to CCRT\" to their original locations. Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link same-study sequencing, interval distributions and treatment delivery"
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What were the randomized/ITT denominators and arm allocations?",
      "needed": "Allocation-to-exposure-to-analysis flow and endpoint/time-specific safety denominators",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What were the randomized/ITT denominators and arm allocations.",
      "application_exception": "The ITT population of 500 is not changed to certification that everyone was observed at five years or had complete imaging, and participants in the two tables are not added together.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What were the randomized/ITT denominators and arm allocations\" to their original locations. Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Distinguish analysis, risk sets and actual exposure within the same allocated population"
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What were allocation, concealment and baseline balance?",
      "needed": "Allocation algorithm/concealment, operational roles and baseline tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What were allocation, concealment and baseline balance.",
      "application_exception": "Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What were allocation, concealment and baseline balance\" to their original locations. Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E01.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use plans/original reports disclosing actual allocation procedures"
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What is the scope of no masking and investigator-assessed PFS?",
      "needed": "Endpoint-specific measurement, assessors, masking/confirmation, schedules and original appendices",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the scope of no masking and investigator-assessed PFS.",
      "application_exception": "Absence of masking alone does not produce automatic failure or a new bias grade, and parent B0 is not inherited as verification of measurement for each outcome.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the scope of no masking and investigator-assessed PFS\" to their original locations. Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link same-trial PFS and OS measurement limitations to each outcome"
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What are the original ITT and censoring records for event-free patients?",
      "needed": "Endpoint-specific ITT/censoring, missingness, sensitivity and analysis-population definitions",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the original ITT and censoring records for event-free patients.",
      "application_exception": "Original ITT and censoring statements are not labeled complete follow-up of every participant or completed current statistical review.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the original ITT and censoring records for event-free patients\" to their original locations. Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link event/censoring/loss flow and original analysis from the same trial"
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "How were adherence, supportive/follow-up treatment and treatment changes handled?",
      "needed": "Actual arm-specific treatment, follow-up/salvage treatment, adherence and handling",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How were adherence, supportive/follow-up treatment and treatment changes handled.",
      "application_exception": "Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How were adherence, supportive/follow-up treatment and treatment changes handled\" to their original locations. Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E02, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use original reports distinguishing allocated-strategy effects from actual treatment delivery"
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What were coprimary PFS/OS and the registration history?",
      "needed": "Original NCT/EudraCT versions, protocol, SAP and coprimary endpoint/time-point comparisons",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What were coprimary PFS/OS and the registration history.",
      "application_exception": "Registry IDs and original statements of agreement are not upgraded to registry access during this work or certification of prespecification.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What were coprimary PFS/OS and the registration history\" to their original locations. Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If original plans are supplied, link coprimary endpoints, amendment times and reporting scope"
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Why did the planned sample change from 700 to 500?",
      "needed": "Original sample/planning changes, events, approvals, statistical assumptions and versions",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Why did the planned sample change from 700 to 500.",
      "application_exception": "The difference between the planned 700 and revised 500 is not calculated as dropout or an efficacy-stopping count; historical statements alone do not currently certify every plan amendment.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Why did the planned sample change from 700 to 500\" to their original locations. Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, E05, C07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use original reports/plans specifying recruitment/planning changes and final-analysis scope"
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Do median follow-up of 67 months, five-year outcomes and exposure duration differ?",
      "needed": "Follow-up distributions, data cutoff, risk sets and time-specific tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Do median follow-up of 67 months, five-year outcomes and exposure duration differ.",
      "application_exception": "The 67 months are not labeled every participant's follow-up duration or treatment duration.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Do median follow-up of 67 months, five-year outcomes and exposure duration differ\" to their original locations. Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, H02.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use original same-trial materials clarifying follow-up and each endpoint's time points"
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment?",
      "needed": "SAP, statistical models, definitions of each estimate/interval and original tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment.",
      "application_exception": "HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment\" to their original locations. HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link original models, adjustment, assumptions and between-arm results"
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Can direct effects of dose, sequence and subgroups be stated?",
      "needed": "Direct comparisons, prespecified subgroups, interactions and actual exposure materials",
      "role": "Supplementary; required for extension",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Can direct effects of dose, sequence and subgroups be stated.",
      "application_exception": "Results for the combined two-drug sequence are not attributed to either drug alone or to a confirmed optimal dose or interval.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Can direct effects of dose, sequence and subgroups be stated\" to their original locations. Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E08, E02.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If suitable direct comparisons specifying population/exposure are supplied, distinguish them from the original strategy"
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "How are report/registration history, original evidence date and current production date separated?",
      "needed": "Publication/registration changes, evidence date, search/correction history and production events",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are report/registration history, original evidence date and current production date separated.",
      "application_exception": "The 2024 report or registry numbers are not used to infer a registration date, and an empty correction list is not labeled current certification of no corrections.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are report/registration history, original evidence date and current production date separated\" to their original locations. Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, C03.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If materials are supplied, preserve original versions and additional dates/correction events separately"
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "What are the event definition and coprimary hierarchy for the selected OS?",
      "needed": "Original OS definition, time origin, verification, coprimary hierarchy and SAP materials.",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the event definition and coprimary hierarchy for the selected OS.",
      "application_exception": "Detailed OS time origin, death verification, original censoring and follow-up, and joint testing rules are unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the event definition and coprimary hierarchy for the selected OS\" to their original locations. Detailed OS time origin, death verification, original censoring and follow-up, and joint testing rules are unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E06, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Original materials disclosing the actual OS definition and analysis and joint plans for the same trial."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What original timepoint and unit do the 5-year OS values of 80% versus 72% represent?",
      "needed": "Original tables for 5-year OS proportions and CI, populations at risk, curves and cutoff.",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What original timepoint and unit do the 5-year OS values of 80% versus 72% represent.",
      "application_exception": "No new difference, NNT, survival months, survivor count or death count is calculated beyond the original 8%p.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What original timepoint and unit do the 5-year OS values of 80% versus 72% represent\" to their original locations. Estimation method, CI, populations at risk, follow-up and censoring, and data cutoff for the five-year proportions are unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, E05.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Original materials defining proportions and time-to-event results together for the same OS."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What are the original OS HR, 95% CI, P and direction?",
      "needed": "Original OS HR and intervals, SAP, models and test definitions.",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the original OS HR, 95% CI, P and direction.",
      "application_exception": "The evidence-list record's label is not changed, and HR is not converted to RR, a new relative reduction percentage or an individual guarantee of preventing death.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the original OS HR, 95% CI, P and direction\" to their original locations. HR model, adjustment and stratification, proportional-hazards assumptions, testing plan and absolute importance thresholds are unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Materials linking original analysis assumptions and plans to the reported interval."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What are the direct values for OS deaths, the 5-year population at risk and denominators?",
      "needed": "Original tables for OS events, risk sets, censoring, and follow-up and analysis denominators.",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the direct values for OS deaths, the 5-year population at risk and denominators.",
      "application_exception": "The 80% and 72% are not multiplied by 250 to back-calculate survivors or deaths, and ITT is not labeled complete observation at five years.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the direct values for OS deaths, the 5-year population at risk and denominators\" to their original locations. Original death-event counts, five-year observed populations and risk sets, censoring and follow-up losses by arm are absent from the summary.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Original materials disclosing deaths, observation and censoring flows for the same allocated population."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "How do all-cause, cancer-specific and treatment-related deaths differ?",
      "needed": "Original OS and cause-of-death tables, with separate materials for the 30-day safety window.",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How do all-cause, cancer-specific and treatment-related deaths differ.",
      "application_exception": "The 1 versus 2 deaths are not substituted for total OS death counts, and no new cause-specific counts are created.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How do all-cause, cancer-specific and treatment-related deaths differ\" to their original locations. Cancer-specific and other cause-specific deaths, total OS event counts, attribution assessment and detailed follow-up are unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, H01, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Materials from the same trial separately defining all-cause, cause-specific and safety deaths."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "What is the scope of OS death verification and measurement without masking?",
      "needed": "Original procedures for OS death verification, follow-up, missingness, assessment and censoring.",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the scope of OS death verification and measurement without masking.",
      "application_exception": "An objective death endpoint alone does not certify complete verification, absence of bias or a new B0.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the scope of OS death verification and measurement without masking\" to their original locations. Death-verification routes, missingness and follow-up, central verification, assessor access and between-arm differences in verification are unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E03.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Materials disclosing OS verification methods and limitations for the same trial."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What are the details of OS ITT, censoring and time origin?",
      "needed": "OS SAP, censoring and missingness, populations at risk, models and sensitivity materials.",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the details of OS ITT, censoring and time origin.",
      "application_exception": "Time origin, administrative end, follow-up loss, censoring assumptions, proportional hazards, subsequent treatment and sensitivity analyses are unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the details of OS ITT, censoring and time origin\" to their original locations. Time origin, administrative end, follow-up loss, censoring assumptions, proportional hazards, subsequent treatment and sensitivity analyses are unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E04, C07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Materials from the same trial specifying original OS follow-up and censoring rules and sensitivity analyses."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What are the reported intervals, absolute importance and joint testing criteria?",
      "needed": "Definitions of OS importance, joint testing and sample assumptions, and original intervals.",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the reported intervals, absolute importance and joint testing criteria.",
      "application_exception": "Positive P, parent B or a large sample is not used to guarantee clinical benefit of every magnitude or an individual outcome.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the reported intervals, absolute importance and joint testing criteria\" to their original locations. Justified important differences, event counts and power, joint alpha, effects of the sample change and proportion CI are unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E05, E06.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If the actual plan is supplied, materials linking importance to intervals and plan changes."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "How is PFS from the same trial reported differently from OS?",
      "needed": "Separate definitions, timepoints, populations, models and original result tables for PFS and OS.",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How is PFS from the same trial reported differently from OS.",
      "application_exception": "PFS values or intervals are not moved to OS, and outcomes or patients are not added to create independent replication or new participant counts.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How is PFS from the same trial reported differently from OS\" to their original locations. PFS progression and death components, assessment, risk sets and event overlap with OS are unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, C08, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Materials from the same trial disclosing separate analyses for the two coprimary outcomes."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Does the OS result also answer questions about symptoms, quality of life and applicability to every population?",
      "needed": "Other patient-centered and long-term outcomes, subgroups and applicability materials separate from survival.",
      "role": "Supplementary; required for extension",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Does the OS result also answer questions about symptoms, quality of life and applicability to every population.",
      "application_exception": "Increased OS does not automatically extend to every symptom, sequela, patient satisfaction or individual benefit in every stage or treatment combination.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Does the OS result also answer questions about symptoms, quality of life and applicability to every population\" to their original locations. Direct values, timepoints and denominators for these outcomes, individual preferences and effects in separate selected populations are unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E09, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If appropriate direct materials are supplied, a text distinguishing OS from separate patient outcomes and population scope."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "What are the people, denominators and proportions for grade 3 or worse adverse events?",
      "needed": "Original safety tables, populations, periods, classification/overlap and comparative statistics",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the people, denominators and proportions for grade 3 or worse adverse events.",
      "application_exception": "No new risk difference, ratio, CI, significance or individual harm incidence is calculated beyond the original 11%p.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the people, denominators and proportions for grade 3 or worse adverse events\" to their original locations. Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H01, H03, H04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link severe adverse events in the same exposed population to definitions, denominators and periods"
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What window and relatedness apply to deaths within 30 days of treatment completion?",
      "needed": "Original treatment-completion, 30-day window, cause/relatedness and denominator tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What window and relatedness apply to deaths within 30 days of treatment completion.",
      "application_exception": "The historical absence of treatment-related deaths within 30 days is not changed to a safety guarantee for every time or harm.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What window and relatedness apply to deaths within 30 days of treatment completion\" to their original locations. Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H02, H04, H09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use original materials disclosing the limited safety window separately from deaths across full follow-up"
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are individual original results available for marrow suppression, infection and neuropathy?",
      "needed": "Original adverse-event type tables, definitions, collection/timing and denominators",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Are individual original results available for marrow suppression, infection and neuropathy.",
      "application_exception": "Original toxicity examples are not asserted to be observed events or rates in particular individuals, and no new user instructions for management or administration are written.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Are individual original results available for marrow suppression, infection and neuropathy\" to their original locations. Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H04, E10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use original materials reporting type-specific safety under the same study exposure"
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "What are safety-exposure, onset/recovery and stopping times?",
      "needed": "Phase-specific safety windows, exposure/stopping/recovery and arm-specific materials",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are safety-exposure, onset/recovery and stopping times.",
      "application_exception": "The median efficacy follow-up of 67 months is not repurposed as the observation or exposure duration for every harm.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are safety-exposure, onset/recovery and stopping times\" to their original locations. Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H02, H04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link period-specific harms to treatment delivery under the same strategy"
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "How are original disease, CCRT, concomitant treatment and harm attribution distinguished?",
      "needed": "Baseline risk, phase/concomitant exposure, event attribution and analysis materials",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are original disease, CCRT, concomitant treatment and harm attribution distinguished.",
      "application_exception": "Original proportions for the combined strategy are not changed to harm or harmlessness of a particular drug alone, or instructions for adjustment.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are original disease, CCRT, concomitant treatment and harm attribution distinguished\" to their original locations. Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H05, E02, E10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use original safety materials distinguishing combined exposure and alternative causes"
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "What is the scope of safety omissions, dropout and selective follow-up?",
      "needed": "Safety-analysis definitions, flow/missingness and event collection/detection",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the scope of safety omissions, dropout and selective follow-up.",
      "application_exception": "Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the scope of safety omissions, dropout and selective follow-up\" to their original locations. Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H06, H04, C07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Use same-trial reports/appendices specifying actual omissions and safety follow-up"
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "Do long-term, rare and vulnerable-population harms require separate direct materials?",
      "needed": "Long-term/rare/population-specific safety, exposure/follow-up and direct comparisons",
      "role": "Supplementary; required for that extension",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Do long-term, rare and vulnerable-population harms require separate direct materials.",
      "application_exception": "Events not specified here are not filled in as zero or no occurrence.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Do long-term, rare and vulnerable-population harms require separate direct materials\" to their original locations. Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H08, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If suitable materials for these scopes are supplied, distinguish them from the currently selected effects/harms"
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "Where was original public/nonprofit funding reported?",
      "needed": "Original funding/COI, sponsor/author-role declarations and data access",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Where was original public/nonprofit funding reported.",
      "application_exception": "Public or nonprofit funding and original I2 alone do not certify current independence, absence of bias or absence of all conflicts of interest.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Where was original public/nonprofit funding reported\" to their original locations. Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link complete original declarations of actual funding, roles and disclosures"
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "What is the scope of no reported company provision of free study drugs?",
      "needed": "Study-drug/in-kind supply and original interest/role declarations",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the scope of no reported company provision of free study drugs.",
      "application_exception": "A statement that something was not reported is not changed to current certification of no involvement or provision by any company.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the scope of no reported company provision of free study drugs\" to their original locations. Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If original declarations are supplied, distinguish unreported matters from actual absence or provision"
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "How are independent replication and the two coprimary outcomes distinguished?",
      "needed": "Family relationships among reports, trials, populations, exact strategies, sources, outcomes and harms",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are independent replication and the two coprimary outcomes distinguished.",
      "application_exception": "The original absence of replication is not changed to zero current studies worldwide, and two tables or endpoints are not counted as new independent replications.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are independent replication and the two coprimary outcomes distinguished\" to their original locations. Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If additional materials are supplied, link shared/separate trials and state the level at which independence was verified"
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "What is the context of null OUTBACK/ACTLACC results under a different sequence?",
      "needed": "Original study citations, exact sequences, populations, comparisons, results and same-strategy scope",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the context of null OUTBACK/ACTLACC results under a different sequence.",
      "application_exception": "Names alone do not create additional report entries or new independent trials, or establish direct superiority of one sequence over another or optimal timing.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the context of null OUTBACK/ACTLACC results under a different sequence\" to their original locations. Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, C02, E07, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If relevant materials are supplied, distinguish sequencing scope without automatically treating it as direct refutation or superiority"
    },
    {
      "item_id": "N42",
      "question_type": "Evidence condition",
      "question": "How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved?",
      "needed": "Separate copies of subclaim/parent values, axes/absences, Korean/English texts and historical verdicts",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved.",
      "application_exception": "Unrecorded precision is not filled in as zero, and parent scores or axes are not inherited by the subclaim or labeled a newly completed review.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved\" to their original locations. Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09, E06.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If corrections are supplied, distinguish full original text, events/versions and decisions and record parent/subclaim scope"
    },
    {
      "item_id": "N43",
      "question_type": "Evidence condition",
      "question": "At what level can survival and toxicity currently be described?",
      "needed": "Efficacy/safety definitions, denominators/periods, original statistics and extrapolation boundaries",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: At what level can survival and toxicity currently be described.",
      "application_exception": "Original increases are not changed to guarantees of individual benefit or harm, and absence of treatment-related deaths within 30 days is not extended to harmlessness.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"At what level can survival and toxicity currently be described\" to their original locations. Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H09, E10, C08, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If original materials are added, update evidence gaps while distinguishing interpretation across outcomes and times"
    },
    {
      "item_id": "N44",
      "question_type": "Evidence condition",
      "question": "Is extrapolation to current treatment, dose or radiotherapy choices avoided?",
      "needed": "Direct population/exposure/comparator, periods and effect/harm materials for extended questions",
      "role": "Supplementary; required for extension of applicability",
      "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Is extrapolation to current treatment, dose or radiotherapy choices avoided.",
      "application_exception": "No new instructions are created for carboplatin or paclitaxel, dose calculation or administration, CCRT or radiotherapy schedules, treatment selection or substitution, suitability or management actions.",
      "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Is extrapolation to current treatment, dose or radiotherapy choices avoided\" to their original locations. Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, E08, H08, H09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: If materials are supplied and scope authorized, update while distinguishing original materials from other application conditions"
    }
  ]
}
