{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "PEGPH20 add-on therapy × increased objective response — evidence sheet for a lower-order endpoint under fixed-sequence testing",
  "language": "en",
  "translation_date": "2026-10-11",
  "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Are the original objective-response subclaim verdict and parent survival grade D distinguished?",
      "needed": "Separate records of subclaim original wording, grade, note and parent context",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of subclaim original wording, grade, note and parent context",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link additional materials separately to the response question and parent survival results."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "Who was actually eligible for response-rate analysis?",
      "needed": "Expression, cancer type, stage, treatment line, baseline conditions and denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Expression, cancer type, stage, treatment line, baseline conditions and denominators",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original eligibility, baseline tumor, biomarker and assessable analysis-population materials."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "Were added PEGPH20, matching placebo and shared anticancer treatment separated?",
      "needed": "Original drug, placebo, shared-treatment and actual-exposure records",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original drug, placebo, shared-treatment and actual-exposure records",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original intervention, placebo, shared regimen and actual-exposure materials."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Are shared thrombosis-prophylaxis conditions and actual management scope retained?",
      "needed": "Prophylaxis, concomitant management, actual exposure, adherence and denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Prophylaxis, concomitant management, actual exposure, adherence and denominators",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original shared-management, prophylactic-exposure, deviation and group-specific event materials."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Are 494 randomized participants, 492 ITT participants and response-rate denominators the same?",
      "needed": "Group-specific allocation, ITT, assessable-imaging and response-analysis denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Group-specific allocation, ITT, assessable-imaging and response-analysis denominators",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original group allocation, response-analysis populations, assessable counts and original responder tables."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What were objective-response criteria, confirmation, times and assessors?",
      "needed": "Imaging criteria, response types, confirmatory assessments, times and measurement procedures",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Imaging criteria, response types, confirmatory assessments, times and measurement procedures",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original response definitions, assessment procedures, assessors, schedules and classification tables."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Were original proportions of 47% versus 36% and missing original responder counts retained?",
      "needed": "Original group-specific proportions, responders, denominators and aggregation rules",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original group-specific proportions, responders, denominators and aggregation rules",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original responders, group-specific analysis denominators and aggregation rules."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Are the response ratio 1.29, CI and new tests distinguished?",
      "needed": "Original ratio, CI, testing, model, denominator and effect definitions",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original ratio, CI, testing, model, denominator and effect definitions",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original ratio definitions, models, intervals, denominators and testing plans."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Was the fixed sequence requiring significant survival first preserved?",
      "needed": "Original plans for testing sequence, alpha, endpoint hierarchy and changes",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original plans for testing sequence, alpha, endpoint hierarchy and changes",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original SAP, fixed sequence, alpha, testing and outcome lists."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Are the prespecified 2019 amendment, sole primary overall survival and response hierarchy distinguished?",
      "needed": "Registration, protocol, SAP, dates and decisions before and after amendment",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Registration, protocol, SAP, dates and decisions before and after amendment",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original registration history, amendment events, protocol and SAP separately."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Were exploratory response signals, clinical importance and confirmatory effects separated?",
      "needed": "Response importance, prespecified success thresholds, hierarchy and original CI",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Response importance, prespecified success thresholds, hierarchy and original CI",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original planned importance, response maintenance, clinical links and hierarchy."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Were null overall survival and increased response preserved together?",
      "needed": "Original OS medians, HR, CI, P, events and denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original OS medians, HR, CI, P, events and denominators",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original OS models, curves, censoring, group-specific events and denominators separately."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "Are null progression-free survival, response duration and progression the same outcome?",
      "needed": "PFS, response duration, imaging-response definitions, effects and denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "PFS, response duration, imaging-response definitions, effects and denominators",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original PFS, response-duration, persistence and progression definitions and tables."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Were central allocation, double-blinding and imaging-assessment details separated?",
      "needed": "Original allocation-concealment, blinding, imaging-assessor and analyst methods",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original allocation-concealment, blinding, imaging-assessor and analyst methods",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original allocation, imaging-assessment, blinding roles and unblinding procedures."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Were gaps in missing response assessments, deviations, progression, death handling and denominators retained?",
      "needed": "Missing imaging assessments, analysis populations, deaths, progression and missing-data rules",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Missing imaging assessments, analysis populations, deaths, progression and missing-data rules",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original assessable populations, reasons for missing assessments, death or progression handling, missing-data handling and sensitivity materials."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "What gaps remain in response interpretation of actual exposure, anticancer intensity, discontinuation or subsequent treatment?",
      "needed": "Added drug, shared anticancer treatment, prophylaxis, crossover, discontinuation and actual exposure",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Added drug, shared anticancer treatment, prophylaxis, crossover, discontinuation and actual exposure",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original exposure, discontinuation, subsequent management and prespecified effect-of-interest materials."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Were response subgroups, expression analyses and multiple outcomes verified prospectively?",
      "needed": "Original plans for subgroups, interactions, hierarchy, denominators and testing",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original plans for subgroups, interactions, hierarchy, denominators and testing",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original subgroup, biomarker, interaction, multiplicity and effect materials."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Were mechanisms and imaging shrinkage not converted into clinical function or survival benefit?",
      "needed": "Separate materials for response, mechanisms and direct clinical function or survival",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate materials for response, mechanisms and direct clinical function or survival",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain direct endpoints, effects and denominators separately for clinical-function, symptom and survival questions."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Were the same HALO report, cohort and two endpoints not added as independent evidence?",
      "needed": "Relationships among original trial, report, shared participants, times and sibling sheets",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Relationships among original trial, report, shared participants, times and sibling sheets",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link new reports to existing trial and registration identifiers and relationships."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Were Halozyme support, drug or placebo, 2 employees and Paragon writing separated?",
      "needed": "Cash support, products, affiliations, management and external analysis or writing roles",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Cash support, products, affiliations, management and external analysis or writing roles",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain each support, supply, affiliation, analysis, management and writing disclosure."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy",
      "question": "Were original R1 and I0 and unverified independent replication retained?",
      "needed": "Relationships among manufacturer trial, funding, investigators and original verdict",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Relationships among manufacturer trial, funding, investigators and original verdict",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link study, funding, author and denominator relationships of additional materials separately."
    },
    {
      "item_id": "N22",
      "question_type": "Supplementary harm evidence",
      "question": "Are grade 3 or worse harm proportions and response benefit displayed separately?",
      "needed": "Original group-specific safety populations, harms, grades, denominators and exposure",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original group-specific safety populations, harms, grades, denominators and exposure",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original safety populations, group-specific events, exposure, grades, discontinuation and denominators."
    },
    {
      "item_id": "N23",
      "question_type": "Supplementary harm evidence",
      "question": "Was the scope of descriptive safety comparisons and no planned inferential testing retained?",
      "needed": "Prespecified safety plans, descriptive tables, relatedness and testing materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Prespecified safety plans, descriptive tables, relatedness and testing materials",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original safety plans, data collection, relatedness and group-specific descriptive tables."
    },
    {
      "item_id": "N24",
      "question_type": "Supplementary harm evidence",
      "question": "Are thrombosis-prophylaxis conditions and gaps in original harm events distinguished?",
      "needed": "Actual prophylaxis, thrombosis events, exposure and group-specific denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Actual prophylaxis, thrombosis events, exposure and group-specific denominators",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original thrombosis-event, prophylactic-exposure, deviation and safety-denominator materials."
    },
    {
      "item_id": "N25",
      "question_type": "Supplementary harm evidence",
      "question": "Were gaps in other, rare or long-term harms, discontinuation and replication evidence retained?",
      "needed": "All harms, discontinuation, duration, exposure and independent-report relationships",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "All harms, discontinuation, duration, exposure and independent-report relationships",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Complete original safety tables, exposure, discontinuation and long-term or rare-harm materials are needed."
    },
    {
      "item_id": "N26",
      "question_type": "Supplementary harm evidence",
      "question": "Were other cancers, treatment lines and clinical applications not automatically extended?",
      "needed": "Direct effect or harm materials by population, combination and prophylaxis",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Direct effect or harm materials by population, combination and prophylaxis",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link direct materials on new populations or combinations to separate questions."
    },
    {
      "item_id": "N27",
      "question_type": "Comparative efficacy",
      "question": "Is reading the preserved summary distinguished from reading external papers, registration, protocol or SAP?",
      "needed": "Original URLs, identifiers, individual material types and actual-reading records",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original URLs, identifiers, individual material types and actual-reading records",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link original materials acquired by the user to types and access states."
    },
    {
      "item_id": "N28",
      "question_type": "Comparative efficacy",
      "question": "Are original dates, Korean and English drafts, empty values, verdict and content-review states distinguished?",
      "needed": "Complete preserved summary, verdict record, original assessment axes, history and current production state",
      "role": "Supplementary",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Complete preserved summary, verdict record, original assessment axes, history and current production state",
      "basis": "Increased objective response",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Reflect additional materials and decisions through preservation of original wording and separate events."
    }
  ]
}