{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Everolimus · advanced hepatocellular carcinoma after sorafenib · evidence check for increased disease control",
  "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": "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": "Review of existing content or actual review 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": "Which existing question is being transferred to this sheet?",
      "needed": "Preserved draft distinguishing the existing question, record location and parent and sibling scopes",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Which existing question is being transferred to this sheet.",
      "application_exception": "The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Which existing question is being transferred to this sheet\" and link them to original locations. The original candidate's boundary-review pending state is historical; review of the existing question boundary remains incomplete.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C01.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: An updated draft retaining the original question and record relationship if additional reports for the same question are supplied"
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "How are the subclaim grade and note distinguished from the parent score and axes?",
      "needed": "Separate locations for the selected subclaim wording and parent verdict history",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: How are the subclaim grade and note distinguished from the parent score and axes.",
      "application_exception": "Do not uniformly change subclaim C or D to D or inherit the parent's 34 points as a subclaim score.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"How are the subclaim grade and note distinguished from the parent score and axes\" and link them to original locations. Direct values for the subclaim score, status and axes are absent from the original.",
      "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: A preserved copy separating complete original wording from the change event when the selected subclaim verdict itself is corrected"
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Do the two sheets concern the same EVOLVE-1 report, trial and population?",
      "needed": "Relationship table for bibliography, registration, shared cohort and individual outcomes",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Do the two sheets concern the same EVOLVE-1 report, trial and population.",
      "application_exception": "Do not add the two sheets' 546 participants, 362/184 or two questions as independent replications or new participants.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Do the two sheets concern the same EVOLVE-1 report, trial and population\" and link them to original locations. Other report versions, follow-up results and current unique study or participant totals have not been established.",
      "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: An outcome-specific material list preserving the same-trial relationship when original or follow-up reports are supplied"
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "What materials were actually read during this work?",
      "needed": "Material records separating the preserved summary from external original materials",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What materials were actually read during this work.",
      "application_exception": "Summary reading is not labeled as reading clinical original materials, and no access attempt is not converted into access failure.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What materials were actually read during this work\" and link them to original locations. External availability, acquisition, reading and link operation were not verified during 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: Material records distinguishing reading level and dates when follow-up work that actually obtains new materials is authorized"
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What is the selected population and previous sorafenib-treatment scope?",
      "needed": "Recruitment criteria, baseline tables, previous treatment and distinctions between failure and intolerance",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What is the selected population and previous sorafenib-treatment scope.",
      "application_exception": "Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What is the selected population and previous sorafenib-treatment scope\" and link them to original locations. Age, sex, etiology, baseline tumor burden, specific inclusion or exclusion criteria and the respective proportions of failure and intolerance are absent from the preserved summary.",
      "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: Comparative materials specifying prespecified population-specific outcomes and scope in the same indication"
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "How are 17 countries, 121 centers and participant distributions related?",
      "needed": "Center, country and recruitment flow and baseline distribution tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: How are 17 countries, 121 centers and participant distributions related.",
      "application_exception": "Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"How are 17 countries, 121 centers and participant distributions related\" and link them to original locations. Recruitment counts by country or center, baseline balance, regional outcomes and follow-up differences remain unverified.",
      "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: Link prespecified subgroup materials on regional or selection differences as outcomes within the same trial when available"
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What was the actual everolimus exposure and dose scope?",
      "needed": "Study product or formulation and nominal or actual exposure and change materials",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What was the actual everolimus exposure and dose scope.",
      "application_exception": "Nominal 7.5 mg/day is not converted into an individual dose or effects of other formulations or doses.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What was the actual everolimus exposure and dose scope\" and link them to original locations. Original formulation, detailed administration route, exposure duration, actual cumulative dose, dose reduction, discontinuation and adherence materials 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: Research materials distinguishing exposure-specific results within the trial conditions when supplied"
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "How are placebo, supportive care and subsequent treatments distinguished?",
      "needed": "Group-specific concomitant and subsequent treatments, departures and analysis handling tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: How are placebo, supportive care and subsequent treatments distinguished.",
      "application_exception": "Matching placebo alone does not establish that all concomitant and subsequent treatments were identical.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"How are placebo, supportive care and subsequent treatments distinguished\" and link them to original locations. Actual supportive-care balance, subsequent anticancer or rescue therapy, departures, crossover and analysis handling 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: Follow-up materials linking subsequent-treatment or crossover information to the original randomized comparison"
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What were randomization, full-analysis and group denominators?",
      "needed": "Allocation-to-exposure-to-analysis flow, endpoint denominators and exclusion reasons",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What were randomization, full-analysis and group denominators.",
      "application_exception": "The full-analysis description is not extended to complete observation of all imaging or safety data or current ITT certification.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What were randomization, full-analysis and group denominators\" and link them to original locations. Endpoint-specific measurable, completed, followed and safety-analysis denominators require separate 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: Original reports distinguishing analysis populations for each outcome within the same allocated population"
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What is the scope of handling missingness, follow-up loss and discontinuation?",
      "needed": "Endpoint-specific missingness or censoring, discontinuation, analysis plans and sensitivity results",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What is the scope of handling missingness, follow-up loss and discontinuation.",
      "application_exception": "Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What is the scope of handling missingness, follow-up loss and discontinuation\" and link them to original locations. Group-specific follow-up loss, administrative censoring, missingness reasons, sensitivity analyses and observation after discontinuation are absent from the original summary.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04, H06.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Supplementary reports of missingness or follow-up materials based on actual flow and original analysis assumptions"
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What original record describes the allocation process?",
      "needed": "Original locations of allocation or concealment procedures and baseline tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What original record describes the allocation process.",
      "application_exception": "Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What original record describes the allocation process\" and link them to original locations. Original details of random-number generation, stratification variables, sequence access, operational roles and baseline balance remain externally unread.",
      "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: Materials linking allocation history and original analysis when registration, protocols or reports are actually supplied"
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Whom and which procedures does the double-blinding record concern?",
      "needed": "Blinded parties, maintenance or unblinding and endpoint-specific assessment procedures",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Whom and which procedures does the double-blinding record concern.",
      "application_exception": "Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Whom and which procedures does the double-blinding record concern\" and link them to original locations. Specific blinding of participants, clinicians, outcome assessors and statisticians, unblinding, success and imaging interpretation 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: Distinguish blinding scope through original materials reporting actual assessment conditions for each outcome"
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Are randomized design and current bias judgments separated?",
      "needed": "Original details of design, allocation, missingness, measurement and selective reporting",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Are randomized design and current bias judgments separated.",
      "application_exception": "Parent B0 and the true large-hard-endpoint-RCT marker are not automatically inherited as fulfillment of conditions for both subclaims.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Are randomized design and current bias judgments separated\" and link them to original locations. Official outcome-specific risk assessment and original-document comparison remain within the user's review scope.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03, E04, E06.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: An updated draft documenting outcome-specific design information when additional original materials are supplied"
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What is the effect of interest for adherence, treatment changes and the randomized comparison?",
      "needed": "Effect of interest, analysis population and handling of adherence or treatment changes",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What is the effect of interest for adherence, treatment changes and the randomized comparison.",
      "application_exception": "PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What is the effect of interest for adherence, treatment changes and the randomized comparison\" and link them to original locations. PP or adherence effects, actual dose intensity and group-specific treatment-change or subsequent-treatment analyses 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: Supplementary reports from the same trial explicitly linking analyses different from the randomized comparison"
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Do outcome collection and assessment procedures fit the actual endpoints?",
      "needed": "Endpoint-specific definitions, methods, assessors, schedules and missing measurements",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Do outcome collection and assessment procedures fit the actual endpoints.",
      "application_exception": "Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Do outcome collection and assessment procedures fit the actual endpoints\" and link them to original locations. Death ascertainment routes, imaging criteria, assessment schedules, central review, assessor blinding and repeated assessments remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E03.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Original reports or appendices linking actual endpoint measurement procedures to reported values"
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Can analysis models, adjustment and between-group or within-group outcomes be distinguished?",
      "needed": "Estimate definitions in statistical methods, SAP and original outcome tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Can analysis models, adjustment and between-group or within-group outcomes be distinguished.",
      "application_exception": "HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Can analysis models, adjustment and between-group or within-group outcomes be distinguished\" and link them to original locations. HR models, adjustment variables, stratification, assumptions, proportion-comparison tests and sensitivity analyses 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: Additional materials publishing original models and distinguishing adjusted from unadjusted outcomes"
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "What is the history of prespecified primary overall survival and registration?",
      "needed": "Original locations of primary endpoints, analyses and times in registration versions, protocol, SAP and report",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What is the history of prespecified primary overall survival and registration.",
      "application_exception": "Original registration-agreement wording is not labeled as current registration reading or prespecification certification.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What is the history of prespecified primary overall survival and registration\" and link them to original locations. Current registration documents, change history, protocol and SAP were not read or compared.",
      "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: A linked draft distinguishing prespecification and reasons for changes in follow-up work that receives actual plan materials"
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "What is the scope of secondary positivity after primary failure and multiplicity?",
      "needed": "Complete primary or secondary outcome lists and multiplicity plans in protocol, SAP and registration",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What is the scope of secondary positivity after primary failure and multiplicity.",
      "application_exception": "P=.01 is not automatically promoted into confirmatory success, survival benefit or a new grade.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What is the scope of secondary positivity after primary failure and multiplicity\" and link them to original locations. Complete secondary endpoint lists, hierarchical testing, multiplicity adjustment, prespecified confirmatory status and changes remain externally unread.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C08, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: A draft distinguishing the statistical scope of secondary outcomes when plan and result materials from the same trial are supplied"
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are direct materials available for subgroups, responders, dose and persistence questions?",
      "needed": "Prespecified subgroup, interaction and exposure-specific original outcomes and plans",
      "role": "Supplementary; required for extension",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Are direct materials available for subgroups, responders, dose and persistence questions.",
      "application_exception": "Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Are direct materials available for subgroups, responders, dose and persistence questions\" and link them to original locations. Prespecified subgroups, interactions, molecular markers, direct dose comparisons and outcomes after treatment discontinuation remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E08, E07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link additional research materials with explicit population or exposure, distinguishing the same from separate study families"
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Can this scope be extended to other liver function, treatment lines or long-term harms?",
      "needed": "Direct comparisons and safety materials by extended population, exposure and duration",
      "role": "Supplementary; required for extension",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Can this scope be extended to other liver function, treatment lines or long-term harms.",
      "application_exception": "No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Can this scope be extended to other liver function, treatment lines or long-term harms\" and link them to original locations. No new search was conducted for direct materials on other populations or exposures, longer observation, rare harms or current treatment combinations.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08, H08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Link materials for separate indications or durations with explicit differences in applicability from the existing results when supplied"
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "What are the definition and secondary hierarchy of disease control?",
      "needed": "DCR definition, response criteria, primary or secondary plans and result tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What are the definition and secondary hierarchy of disease control.",
      "application_exception": "C is the selected subclaim's historical grade; it is not changed into parent D34 or a current clinical verdict.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What are the definition and secondary hierarchy of disease control\" and link them to original locations. Response or stable-disease components, imaging assessment criteria, duration conditions and definitions of comparable assessed populations remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E06, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Original reports or appendices from the same trial specifying disease-control definitions and analysis scope"
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What original between-group values are 56.1% versus 45.1% and P=.01?",
      "needed": "Original DCR result tables, denominators, CI and testing or adjustment methods",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What original between-group values are 56.1% versus 45.1% and P=.01.",
      "application_exception": "Do not back-calculate new responder counts, differences, OR/RR or CI from rounded proportions.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What original between-group values are 56.1% versus 45.1% and P=.01\" and link them to original locations. The summary does not contain CI for the estimate, analysis methods for the proportion difference, adjustments or multiplicity handling.",
      "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: The same DCR report jointly presenting proportions, effect intervals and plans"
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What are the DCR denominators and numbers of people with disease control?",
      "needed": "Original DCR sample and event tables, assessment flow and analysis-population definitions",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What are the DCR denominators and numbers of people with disease control.",
      "application_exception": "OS denominators 362/184 are not transferred into verified DCR denominators, and responder counts are not calculated from proportions.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What are the DCR denominators and numbers of people with disease control\" and link them to original locations. Group-specific DCR denominators, numerators, completed imaging assessments, missing assessments and analysis-inclusion rules 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: Original result tables distinguishing randomized, analyzed, assessable and disease-control denominators"
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "How are non-assessment, death, progression and stable disease handled in DCR?",
      "needed": "DCR analysis rules, response classification and missing-data or death-handling tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: How are non-assessment, death, progression and stable disease handled in DCR.",
      "application_exception": "Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"How are non-assessment, death, progression and stable disease handled in DCR\" and link them to original locations. Classification, missing-data handling and sensitivity analyses for non-assessment, early death, progression and incomplete imaging remain 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 specifying original DCR analyses for non-assessment, death or discontinuation"
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What are the DCR assessment times and minimum duration?",
      "needed": "DCR definition, assessment schedule, minimum duration and data-cutoff date",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What are the DCR assessment times and minimum duration.",
      "application_exception": "Median OS of 7.6/7.3 months or TTP of 3.0/2.6 months are not used to fill DCR assessment periods.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What are the DCR assessment times and minimum duration\" and link them to original locations. Whether this was best overall response or a particular time point, minimum stable-disease duration, imaging intervals and data cutoff remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E03, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Materials from the same trial linking time-specific or duration-specific DCR to original analyses"
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "What is the scope of imaging interpretation, central or local assessment and assessor blinding?",
      "needed": "DCR imaging criteria, assessors, original interpretation methods and appendices",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What is the scope of imaging interpretation, central or local assessment and assessor blinding.",
      "application_exception": "The original double-blind design does not automatically certify completed central imaging interpretation or absence of measurement bias.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What is the scope of imaging interpretation, central or local assessment and assessor blinding\" and link them to original locations. Tumor-assessment criteria, measurement error, central or local interpretation, assessor blinding and response confirmation remain 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 from the same trial reporting actual DCR measurement or interpretation procedures and their agreement or differences"
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What are DCR effect intervals, clinical importance and multiplicity?",
      "needed": "DCR effect intervals, SAP, primary or secondary testing order and importance criteria",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What are DCR effect intervals, clinical importance and multiplicity.",
      "application_exception": "P=.01 alone does not establish every effect size, current confirmatory success or individual clinical benefit.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What are DCR effect intervals, clinical importance and multiplicity\" and link them to original locations. CI for the DCR effect, prespecified importance, hierarchical or multiplicity adjustment and confirmatory status remain 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: Materials linking planned and reported DCR intervals and testing scope"
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are positive DCR and the null primary overall-survival result distinguished?",
      "needed": "Definitions, denominators, estimates and plans for each endpoint and their same-trial relationship",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Are positive DCR and the null primary overall-survival result distinguished.",
      "application_exception": "Positive DCR is not transferred into increased OS, and the null OS result does not justify deleting preserved DCR values.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Are positive DCR and the null primary overall-survival result distinguished\" and link them to original locations. External materials directly verifying differences in models, times or denominators between the two endpoints and the DCR-OS relationship remain unread.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Original same-trial result tables presenting DCR and OS together without merging them"
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "What are the units and directions of time to progression and DCR?",
      "needed": "TTP definition and original results, DCR definition and separation of the two analyses",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What are the units and directions of time to progression and DCR.",
      "application_exception": "TTP is not converted into PFS, DCR duration or survival benefit, and no difference between medians is calculated.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What are the units and directions of time to progression and DCR\" and link them to original locations. Progression assessment, censoring or death handling, denominators, P and links to DCR assessment times remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C08, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: The same report linking original tumor assessments to progression-time definitions and follow-up"
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Does disease control answer questions about patient symptoms, quality of life or long-term outcomes?",
      "needed": "Direct DCR and patient-centered outcome materials, times, denominators and original analyses",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Does disease control answer questions about patient symptoms, quality of life or long-term outcomes.",
      "application_exception": "Survival success is not imposed as mandatory for DCR itself, but DCR is not automatically extended into other patient benefits.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Does disease control answer questions about patient symptoms, quality of life or long-term outcomes\" and link them to original locations. This summary does not contain patient-reported symptoms, quality of life, tumor-control duration, individual benefit or mediation or surrogate validation.",
      "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: Materials separately reporting tumor control and patient-centered outcomes in the same or an appropriate separate study"
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "What was the original all-grade stomatitis comparison?",
      "needed": "Original stomatitis tables, safety population, grading criteria and duration",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What was the original all-grade stomatitis comparison.",
      "application_exception": "Stomatitis event counts, safety denominators, collection or classification, times, CI and P remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What was the original all-grade stomatitis comparison\" and link them to original locations. Stomatitis event counts, safety denominators, collection or classification, times, CI and P 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: Original safety materials linking stomatitis in the same exposed population with denominators and duration"
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What were the grade 3 or 4 anemia comparison and original statistical level?",
      "needed": "Anemia safety tables, denominators or duration, classification and baseline status",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What were the grade 3 or 4 anemia comparison and original statistical level.",
      "application_exception": "Descriptive proportions are not newly calculated into significant risk increases, no-difference tests or incidence rates.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What were the grade 3 or 4 anemia comparison and original statistical level\" and link them to original locations. Anemia event counts, denominators, baseline anemia, grading criteria, between-group CI or P and timing 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: Materials publishing hematologic harms from the same trial at the original population, timing and analysis level"
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What were the original grade 3 or 4 asthenia and decreased-appetite values?",
      "needed": "Original tables, denominators, grading, collection and timing for each safety event",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What were the original grade 3 or 4 asthenia and decreased-appetite values.",
      "application_exception": "Do not merge the two symptoms into a new composite event, participant total or risk difference.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What were the original grade 3 or 4 asthenia and decreased-appetite values\" and link them to original locations. Event-specific denominators, participants versus event counts, co-occurring events, causes or timing, CI or P and classifications remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H03, H04, E10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Safety materials reporting asthenia and decreased appetite as separate events under the same exposure"
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "How are asymptomatic hepatitis B reactivation and discontinuation distinguished?",
      "needed": "HBV testing criteria, populations at risk, group denominators or follow-up and original discontinuation tables",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: How are asymptomatic hepatitis B reactivation and discontinuation distinguished.",
      "application_exception": "Do not divide 29/10 or 3 discontinuations by full allocated denominators to calculate new proportions or risks.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"How are asymptomatic hepatitis B reactivation and discontinuation distinguished\" and link them to original locations. Reactivation criteria, baseline HBV or at-risk denominators, testing times, prophylaxis, discontinuation timing or attribution and CI or P remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H02, H03, H04, H05.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Safety materials linking HBV reactivation and discontinuation under the same exposure with populations at risk"
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "What is the scope of safety denominators, exposure duration and complete collection?",
      "needed": "Safety analysis definitions, exposure, all-event tables and collection or follow-up materials",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What is the scope of safety denominators, exposure duration and complete collection.",
      "application_exception": "Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What is the scope of safety denominators, exposure duration and complete collection\" and link them to original locations. Safety populations, actual exposure durations, event-specific populations at risk, collection or follow-up, post-discontinuation events, losses and rare harms remain unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H02, H04, H06, H08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Original reports from the same trial specifying safety populations, timing and missingness"
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "What are baseline disease, concurrent treatment and alternative causes of harms?",
      "needed": "Baseline risks, concomitant or subsequent treatments, event attribution and original analyses",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What are baseline disease, concurrent treatment and alternative causes of harms.",
      "application_exception": "Do not newly assert that other causes were absent or all events were caused by everolimus.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What are baseline disease, concurrent treatment and alternative causes of harms\" and link them to original locations. Baseline liver disease or HBV, anemia, concurrent medications, subsequent treatment, alternative causes and group-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: Supplementary safety materials separately publishing baseline disease and exposure or event relationships"
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "Who supplied research funding, study medication and placebo?",
      "needed": "Original funding, product supply, contracts and disclosed interests",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Who supplied research funding, study medication and placebo.",
      "application_exception": "Original contracts, funding details, complete individual-interest disclosures and current changes remain externally unread. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Who supplied research funding, study medication and placebo\" and link them to original locations. Original contracts, funding details, complete individual-interest disclosures and current changes 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: Original materials publishing actual-report funding, product supply and roles together"
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "How did the sponsor participate in design, data collection and analysis?",
      "needed": "Design, collection and analysis role declarations, data access and statistical responsibility",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: How did the sponsor participate in design, data collection and analysis.",
      "application_exception": "Sponsor involvement alone does not justify deleting original numbers or deriving a new null effect or bias magnitude.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"How did the sponsor participate in design, data collection and analysis\" and link them to original locations. Specific scope of full data access, original statistical responsibility, independent reanalysis and operational contracts remains unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C10, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Original declarations or supplementary materials specifying reported roles and the scope of actual analysis disclosure"
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "What were employee-author, writing and submission-decision roles?",
      "needed": "Author employment or COI, contributions, writing and publication-role declarations",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What were employee-author, writing and submission-decision roles.",
      "application_exception": "Complete individual-author COI, writing or approval and submission-authority contracts and role changes remain unverified. Preserve both relevant summary information and unverified matters; empty values are not filled with new numbers or verdicts.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What were employee-author, writing and submission-decision roles\" and link them to original locations. Complete individual-author COI, writing or approval and submission-authority contracts and role changes 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: Materials linking original author or sponsor roles and disclosed interests"
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "What is the actual scope of independent replication or separate safety materials?",
      "needed": "Reports, study families, COI, shared outcomes and contrary-material lists",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: What is the actual scope of independent replication or separate safety materials.",
      "application_exception": "One literature record or two existing sheets are not converted into current worldwide trial totals or confirmed independent replication.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"What is the actual scope of independent replication or separate safety materials\" and link them to original locations. No new search was conducted for independent trials, additional report or cohort lists, duplicate events or external safety or regulatory materials.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, C10, E07, H07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Relationship records specifying repeated citation, shared populations or separate populations when separate materials are actually supplied"
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "At what level are efficacy outcomes and descriptive harms described?",
      "needed": "Original efficacy and safety tables, definitions, denominators or times and interpretive scope",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: At what level are efficacy outcomes and descriptive harms described.",
      "application_exception": "Non-significant survival or positive DCR does not erase harms, and descriptive statistics alone do not create a new causal safety verdict.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"At what level are efficacy outcomes and descriptive harms described\" and link them to original locations. Current synthesis of event-specific comparative estimates, causal attribution and long-term or rare harms remains unverified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H09, C08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Original reports separately specifying the different analysis levels for efficacy and harms"
    },
    {
      "item_id": "N42",
      "question_type": "Evidence condition",
      "question": "How are parent grade, score, false or empty axis values and Korean or English drafts preserved?",
      "needed": "Separate copies preserving subclaim and parent values, Korean or English drafts, axes and historical verdict",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: How are parent grade, score, false or empty axis values and Korean or English drafts preserved.",
      "application_exception": "The parent's 34 points, B0/C0 or cross-check-applied history are not inherited as subclaim scores or axes, new fulfillment or review completion.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"How are parent grade, score, false or empty axis values and Korean or English drafts preserved\" and link them to original locations. Original cross-checking, grades and axes were not automatically applied as current review completion or selected subclaim values.",
      "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: Preserved records separating complete pre-change originals, events, versions and decisions when verdict corrections are actually supplied"
    },
    {
      "item_id": "N43",
      "question_type": "Evidence condition",
      "question": "Do the cutoff date, corrections and empty values differ from current production dates?",
      "needed": "Distinguishing original cutoff, correction, retraction or search history from production events",
      "role": "Required",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Do the cutoff date, corrections and empty values differ from current production dates.",
      "application_exception": "Empty correction history is not certified as no current corrections, and the original verification date is not changed into the current review date.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Do the cutoff date, corrections and empty values differ from current production dates\" and link them to original locations. Original additional-cutoff and detailed-classification fields are absent; no new search, registration, correction or retraction comparison or external reading was 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: Update records distinguishing historical scope from current additional events when materials or corrections are actually supplied"
    },
    {
      "item_id": "N44",
      "question_type": "Evidence condition",
      "question": "Is the scope kept from extending to current applicability, products or treatment decisions?",
      "needed": "Appropriate direct materials for extended questions and applicability differences from the original trial",
      "role": "Supplementary; required for extending applicability",
      "role_reason": "This condition is needed to separately document the selected increased-disease-control question: Is the scope kept from extending to current applicability, products or treatment decisions.",
      "application_exception": "No new medication or dosing instructions, substitution or discontinuation of sorafenib or other treatments, or anticancer-treatment choices are created.",
      "criterion": "Distinguish preserved values, direct scope and unverified matters relevant to \"Is the scope kept from extending to current applicability, products or treatment decisions\" and link them to original locations. Current clinical practice, product or regulatory status, individual suitability and direct superiority of other treatments were not verified.",
      "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, E08, E09, H08, H09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Proposal: Research-gap updates distinguishing selected scope, outcomes and harms when additional materials are authorized and supplied"
    }
  ]
}