{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2936-s1", "verdict_number": "2936", "title": "INTERLACE induction carboplatin and paclitaxel · Locally advanced cervical cancer · Evidence checklist for increased five-year overall survival", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from the designated preserved summary. External abstracts, full papers, registries and plans remain unread, with no access attempted. Existing content review remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Locally advanced cervical cancer; INTERLACE, 500 participants at 32 centers. Exact stage, age, eligibility and baseline characteristics are unverified.", "intervention": "The original combined strategy of six weeks of induction carboplatin and paclitaxel immediately before standard CCRT.", "dose": "AUC 2, 80 mg/m², once weekly for six weeks and a median seven-day interval are historical study conditions; no conversion, use or dosing recommendations are provided.", "comparator": "Standard concurrent chemoradiotherapy alone. Detailed chemotherapy and radiotherapy schedules and balance of supportive and subsequent treatment are unverified.", "endpoint": "Co-primary OS, defined by all-cause death; five-year proportions and HR.", "duration": "Five-year outcomes, median follow-up of 67 months, six weeks of induction, a median seven-day interval and deaths within 30 days of treatment completion are separate periods. Overall exposure, populations at risk and safety periods are unverified.", "excluded_extensions": [ "Attribution of efficacy to either drug alone or to other doses, sequences, products or radiotherapy schedules.", "Summing events or populations across PFS, OS, safety and the 30-day window.", "New reduction percentages or NNT, or back-calculated participant counts from HR or five-year proportions.", "Individual suitability, treatment selection, administration, dose conversion or treatment-substitution instructions.", "Inheriting joint outcomes, public funding or parent B0/I2 as new certification of independence or completed review." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What are the selected question, verdict record and parent context?", "needed": "Original question/record and links to parent/related outcomes", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the selected question, verdict record and parent context.", "application_exception": "Historical candidate-boundary review pending status is preserved as history; existing content and question-boundary review remain incomplete. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the selected question, verdict record and parent context\" to their original locations. Historical candidate-boundary review pending status is preserved as history; existing content and question-boundary review remain incomplete.", "basis": "Own question-specific application conditions informed by the preserved summary and family definition C01.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If new materials for the same question are supplied, link them while preserving the existing record and original wording", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The selected existing question is improved 5-year overall survival; the question and its existing verdict record are preserved separately. The parent explains both coprimary survival results, while this table concerns the selected result itself.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.", "uncertainty": "The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original question/record and links to parent/related outcomes" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are original subclaim B/note, parent B76 and absent score/axes separated?", "needed": "A preserved copy separating the subclaim verdict/note from parent score/axes", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are original subclaim B/note, parent B76 and absent score/axes separated.", "application_exception": "A blanket D or the parent's score of 76 and axes are not inherited by the selected subclaim; no new grade or score is created.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are original subclaim B/note, parent B76 and absent score/axes separated\" to their original locations. Direct selected-subclaim score, status and axes values are absent.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If a subclaim correction is actually supplied, record the complete original text, event and change decision separately", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original subclaim grade B and note ‘80% versus 72%, HR 0.60’ are preserved. The selected subclaim has no score, status or axes; parent B, 76, Caution and axes are historical parent context.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Direct selected-subclaim score, status and axes values are absent. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "There are no direct values for the selected subclaim score, status or axes.", "uncertainty": "There are no direct values for the selected subclaim score, status or axes.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "A preserved copy separating the subclaim verdict/note from parent score/axes" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Do both tables, PFS, OS and safety concern the same trial?", "needed": "Relationships among reports, registration, trial families, outcomes/time points and shared populations", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Do both tables, PFS, OS and safety concern the same trial.", "application_exception": "The two questions, survival curves, endpoints, centers or 500 participants with 250 per arm are not added as new independent replications or participants.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Do both tables, PFS, OS and safety concern the same trial\" to their original locations. Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If follow-up or other materials are supplied, distinguish shared reports/populations/outcomes from separate families", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "1 original evidence entry and 1 citation entry link McCormack et al. 2024 GCIG INTERLACE, PMID39419054. PFS, OS, safety and both existing tables share results from the same trial and 500-person, 250/250 population.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.", "uncertainty": "Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relationships among reports, registration, trial families, outcomes/time points and shared populations" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which preserved summary and external original materials have currently been read?", "needed": "Existence, acquisition, reading status and original locations of the preserved summary and external materials", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Which preserved summary and external original materials have currently been read.", "application_exception": "Summary reading is not labeled full-text or registry reading, and an access attempt that was not made is not changed to failed access or absent materials.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Which preserved summary and external original materials have currently been read\" to their original locations. External availability/acquisition, current content, link operation and access success were not verified in this work.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C03.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: When obtaining follow-up materials is authorized, record actual reading level and distinguish historical from current dates", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The complete designated preserved summary was read for production and its original bytes preserved. The original PubMed URL is linked unchanged; external abstracts, papers, registration and plans remain unread.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. External availability/acquisition, current content, link operation and access success were not verified in this work. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "External availability/acquisition, current content, link operation and access success were not verified in this work.", "uncertainty": "External availability/acquisition, current content, link operation and access success were not verified in this work.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existence, acquisition, reading status and original locations of the preserved summary and external materials" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What were the actual population and selection scope for locally advanced cervical cancer?", "needed": "Original eligibility/exclusion, stage and baseline-characteristic tables", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What were the actual population and selection scope for locally advanced cervical cancer.", "application_exception": "Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What were the actual population and selection scope for locally advanced cervical cancer\" to their original locations. Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use materials from the same trial specifying original recruitment conditions, or suitable separate population research", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The preserved parent question concerns locally advanced cervical cancer in the 500-person INTERLACE trial. Specific recruitment/exclusion and baseline composition lie beyond the summary.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.", "uncertainty": "Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original eligibility/exclusion, stage and baseline-characteristic tables" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What do 32 centers, the international multicenter design and population distribution describe?", "needed": "Center/region and recruitment distribution, baseline balance and treatment-delivery materials", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What do 32 centers, the international multicenter design and population distribution describe.", "application_exception": "The 32 centers are not labeled independent trials, and no country list or distribution is invented.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What do 32 centers, the international multicenter design and population distribution describe\" to their original locations. Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E01, E07.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use supplementary same-trial materials reporting actual regional conditions and results", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original research description states that INTERLACE assigned 500 people at 32 centers, 250 per group; the evidence design is an international multicenter randomized phase 3 trial.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.", "uncertainty": "Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Center/region and recruitment distribution, baseline balance and treatment-delivery materials" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What are the sequence of induction chemotherapy before radiation and the comparator strategy?", "needed": "Original protocols, shared treatment, sequencing and delivery for both strategies", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the sequence of induction chemotherapy before radiation and the comparator strategy.", "application_exception": "The study sequence is not written as an individual treatment plan, treatment selection or guidance for another sequence.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the sequence of induction chemotherapy before radiation and the comparator strategy\" to their original locations. Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use reports/appendices defining the original comparison of induction addition and standard CCRT", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The trial compares adding 6 weeks of induction carboplatin-paclitaxel before standard concurrent chemoradiotherapy with standard concurrent chemoradiotherapy alone. The original citation title and Korean/English texts are linked unchanged.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.", "uncertainty": "Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocols, shared treatment, sequencing and delivery for both strategies" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How are nominal induction exposure and actual administered amounts separated?", "needed": "Original nominal/actual exposure, changes, adherence, formulation and route materials", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are nominal induction exposure and actual administered amounts separated.", "application_exception": "AUC 2 is not converted to mg or mg/kg, and 80 mg/m² is not turned into an individual dose or instructions for use.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are nominal induction exposure and actual administered amounts separated\" to their original locations. Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Link actual administration/stopping and results from the same study", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Original study exposure was carboplatin AUC 2 and paclitaxel 80 mg/m², once weekly (1 administration per week) for 6 weeks. Original units/frequency are preserved only as historical study conditions.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.", "uncertainty": "Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original nominal/actual exposure, changes, adherence, formulation and route materials" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What was the median interval from induction completion to CCRT?", "needed": "Original interval, delay, non-delivery, actual schedule and completion tables", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What was the median interval from induction completion to CCRT.", "application_exception": "The median seven-day interval is not turned into an identical interval for every participant or a recommendation on when to start treatment.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What was the median interval from induction completion to CCRT\" to their original locations. Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Link same-study sequencing, interval distributions and treatment delivery", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original study-condition description gives a median interval of 7 days. It is preserved together with the research description that CCRT began approximately 1 week later.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.", "uncertainty": "Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original interval, delay, non-delivery, actual schedule and completion tables" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What were the randomized/ITT denominators and arm allocations?", "needed": "Allocation-to-exposure-to-analysis flow and endpoint/time-specific safety denominators", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What were the randomized/ITT denominators and arm allocations.", "application_exception": "The ITT population of 500 is not changed to certification that everyone was observed at five years or had complete imaging, and participants in the two tables are not added together.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What were the randomized/ITT denominators and arm allocations\" to their original locations. Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Distinguish analysis, risk sets and actual exposure within the same allocated population", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Original sample wording is 500 randomized and 500 ITT participants (250/250). The original history describes both outcomes as analyses of this same allocated population.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.", "uncertainty": "Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation-to-exposure-to-analysis flow and endpoint/time-specific safety denominators" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What were allocation, concealment and baseline balance?", "needed": "Allocation algorithm/concealment, operational roles and baseline tables", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What were allocation, concealment and baseline balance.", "application_exception": "Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What were allocation, concealment and baseline balance\" to their original locations. Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E01.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use plans/original reports disclosing actual allocation procedures", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original quote states, 'Allocation was done by minimisation, using a central electronic system'. The central-electronic-system minimisation record is preserved.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.", "uncertainty": "Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation algorithm/concealment, operational roles and baseline tables" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What is the scope of no masking and investigator-assessed PFS?", "needed": "Endpoint-specific measurement, assessors, masking/confirmation, schedules and original appendices", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the scope of no masking and investigator-assessed PFS.", "application_exception": "Absence of masking alone does not produce automatic failure or a new bias grade, and parent B0 is not inherited as verification of measurement for each outcome.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the scope of no masking and investigator-assessed PFS\" to their original locations. Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Link same-trial PFS and OS measurement limitations to each outcome", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original quote states, 'No blinding or masking was performed', and identifies investigator-assessed PFS and all-cause death. Wording that masking was infeasible for the induction sequence remains historical context.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.", "uncertainty": "Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific measurement, assessors, masking/confirmation, schedules and original appendices" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What are the original ITT and censoring records for event-free patients?", "needed": "Endpoint-specific ITT/censoring, missingness, sensitivity and analysis-population definitions", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the original ITT and censoring records for event-free patients.", "application_exception": "Original ITT and censoring statements are not labeled complete follow-up of every participant or completed current statistical review.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the original ITT and censoring records for event-free patients\" to their original locations. Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Link event/censoring/loss flow and original analysis from the same trial", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original statement 'Analyses were by intention-to-treat (ITT)' and censoring of event-free patients at the last known alive date are preserved.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.", "uncertainty": "Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific ITT/censoring, missingness, sensitivity and analysis-population definitions" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How were adherence, supportive/follow-up treatment and treatment changes handled?", "needed": "Actual arm-specific treatment, follow-up/salvage treatment, adherence and handling", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How were adherence, supportive/follow-up treatment and treatment changes handled.", "application_exception": "Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How were adherence, supportive/follow-up treatment and treatment changes handled\" to their original locations. Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E02, E04.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use original reports distinguishing allocated-strategy effects from actual treatment delivery", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original allocated-strategy comparison is induction chemotherapy followed by CCRT versus CCRT alone. The two drugs/radiation sequence must be distinguished from actual delivery and subsequent interventions.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.", "uncertainty": "Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual arm-specific treatment, follow-up/salvage treatment, adherence and handling" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What were coprimary PFS/OS and the registration history?", "needed": "Original NCT/EudraCT versions, protocol, SAP and coprimary endpoint/time-point comparisons", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What were coprimary PFS/OS and the registration history.", "application_exception": "Registry IDs and original statements of agreement are not upgraded to registry access during this work or certification of prespecification.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What were coprimary PFS/OS and the registration history\" to their original locations. Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C09.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If original plans are supplied, link coprimary endpoints, amendment times and reporting scope", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original quote 'The primary endpoints were overall survival and investigator-assessed progression-free survival' and stated agreement with NCT01566240 are preserved. The evidence registration entry is NCT01566240 · EudraCT 2011-001300-35.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.", "uncertainty": "Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original NCT/EudraCT versions, protocol, SAP and coprimary endpoint/time-point comparisons" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Why did the planned sample change from 700 to 500?", "needed": "Original sample/planning changes, events, approvals, statistical assumptions and versions", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Why did the planned sample change from 700 to 500.", "application_exception": "The difference between the planned 700 and revised 500 is not calculated as dropout or an efficacy-stopping count; historical statements alone do not currently certify every plan amendment.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Why did the planned sample change from 700 to 500\" to their original locations. Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, E05, C07.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use original reports/plans specifying recruitment/planning changes and final-analysis scope", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original counterview states that the planned sample decreased from 700 to 500 because of slow recruitment, rather than stopping early at an efficacy boundary.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.", "uncertainty": "Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original sample/planning changes, events, approvals, statistical assumptions and versions" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Do median follow-up of 67 months, five-year outcomes and exposure duration differ?", "needed": "Follow-up distributions, data cutoff, risk sets and time-specific tables", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Do median follow-up of 67 months, five-year outcomes and exposure duration differ.", "application_exception": "The 67 months are not labeled every participant's follow-up duration or treatment duration.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Do median follow-up of 67 months, five-year outcomes and exposure duration differ\" to their original locations. Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, H02.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use original same-trial materials clarifying follow-up and each endpoint's time points", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original rationale reports 5-year PFS/OS at median follow-up of 67 months. 6 weeks of induction, a median 7-day interval and 5-year endpoints are distinct time values.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.", "uncertainty": "Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up distributions, data cutoff, risk sets and time-specific tables" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment?", "needed": "SAP, statistical models, definitions of each estimate/interval and original tables", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment.", "application_exception": "HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment\" to their original locations. HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Link original models, adjustment, assumptions and between-arm results", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Original numbers are between-arm HR, CI and P and each arm's 5-year survival proportion. They are not written as individual survival-time gains or within-arm change from baseline.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.", "uncertainty": "HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, statistical models, definitions of each estimate/interval and original tables" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Can direct effects of dose, sequence and subgroups be stated?", "needed": "Direct comparisons, prespecified subgroups, interactions and actual exposure materials", "role": "Supplementary; required for extension", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Can direct effects of dose, sequence and subgroups be stated.", "application_exception": "Results for the combined two-drug sequence are not attributed to either drug alone or to a confirmed optimal dose or interval.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Can direct effects of dose, sequence and subgroups be stated\" to their original locations. Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E08, E02.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If suitable direct comparisons specifying population/exposure are supplied, distinguish them from the original strategy", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original comparison adds a specific 6-week weekly induction combination-chemotherapy sequence. The summary does not state that individual drug contributions, other intervals/doses or subgroup superiority were directly compared.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.", "uncertainty": "Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons, prespecified subgroups, interactions and actual exposure materials" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "How are report/registration history, original evidence date and current production date separated?", "needed": "Publication/registration changes, evidence date, search/correction history and production events", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are report/registration history, original evidence date and current production date separated.", "application_exception": "The 2024 report or registry numbers are not used to infer a registration date, and an empty correction list is not labeled current certification of no corrections.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are report/registration history, original evidence date and current production date separated\" to their original locations. Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, C03.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If materials are supplied, preserve original versions and additional dates/correction events separately", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original citation is the 2024 Lancet report and the original evidence date is 2026-08-26. Empty corrections/deliberation and historical Korean/English quotes are preserved. The current timestamp marks content production.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.", "uncertainty": "Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Publication/registration changes, evidence date, search/correction history and production events" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What are the event definition and coprimary hierarchy for the selected OS?", "needed": "Original OS definition, time origin, verification, coprimary hierarchy and SAP materials.", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the event definition and coprimary hierarchy for the selected OS.", "application_exception": "Detailed OS time origin, death verification, original censoring and follow-up, and joint testing rules are unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the event definition and coprimary hierarchy for the selected OS\" to their original locations. Detailed OS time origin, death verification, original censoring and follow-up, and joint testing rules are unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E06, E04.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Original materials disclosing the actual OS definition and analysis and joint plans for the same trial.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The selected question is improved 5-year overall survival. The original names OS and investigator-assessed PFS as coprimary endpoints; the original research-description context defines OS as death from any cause.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Detailed OS time origin, death verification, original censoring and follow-up, and joint testing rules are unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Detailed OS time origin, death verification, original censoring and follow-up, and joint testing rules are unverified.", "uncertainty": "Detailed OS time origin, death verification, original censoring and follow-up, and joint testing rules are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original OS definition, time origin, verification, coprimary hierarchy and SAP materials." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What original timepoint and unit do the 5-year OS values of 80% versus 72% represent?", "needed": "Original tables for 5-year OS proportions and CI, populations at risk, curves and cutoff.", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What original timepoint and unit do the 5-year OS values of 80% versus 72% represent.", "application_exception": "No new difference, NNT, survival months, survivor count or death count is calculated beyond the original 8%p.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What original timepoint and unit do the 5-year OS values of 80% versus 72% represent\" to their original locations. Estimation method, CI, populations at risk, follow-up and censoring, and data cutoff for the five-year proportions are unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, E05.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Original materials defining proportions and time-to-event results together for the same OS.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "5-year OS for the induction strategy versus CCRT alone was 80% versus 72%. The original core and synthesis statements of an 8%p increase for each outcome are retained. These are each arm's 5-year survival proportions, not gains in survival duration.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Estimation method, CI, populations at risk, follow-up and censoring, and data cutoff for the five-year proportions are unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Estimation method, CI, populations at risk, follow-up and censoring, and data cutoff for the five-year proportions are unverified.", "uncertainty": "Estimation method, CI, populations at risk, follow-up and censoring, and data cutoff for the five-year proportions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables for 5-year OS proportions and CI, populations at risk, curves and cutoff." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What are the original OS HR, 95% CI, P and direction?", "needed": "Original OS HR and intervals, SAP, models and test definitions.", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the original OS HR, 95% CI, P and direction.", "application_exception": "The evidence-list record's label is not changed, and HR is not converted to RR, a new relative reduction percentage or an individual guarantee of preventing death.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the original OS HR, 95% CI, P and direction\" to their original locations. HR model, adjustment and stratification, proportional-hazards assumptions, testing plan and absolute importance thresholds are unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Materials linking original analysis assumptions and plans to the reported interval.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "OS HR 0.60 (95% CI 0.40–0.91), P=.015 appears in the original rationale and reader answer. The OS interval in the evidence list is preserved without a confidence-level label. Each location is linked separately.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. HR model, adjustment and stratification, proportional-hazards assumptions, testing plan and absolute importance thresholds are unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "HR model, adjustment and stratification, proportional-hazards assumptions, testing plan and absolute importance thresholds are unverified.", "uncertainty": "HR model, adjustment and stratification, proportional-hazards assumptions, testing plan and absolute importance thresholds are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original OS HR and intervals, SAP, models and test definitions." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What are the direct values for OS deaths, the 5-year population at risk and denominators?", "needed": "Original tables for OS events, risk sets, censoring, and follow-up and analysis denominators.", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the direct values for OS deaths, the 5-year population at risk and denominators.", "application_exception": "The 80% and 72% are not multiplied by 250 to back-calculate survivors or deaths, and ITT is not labeled complete observation at five years.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the direct values for OS deaths, the 5-year population at risk and denominators\" to their original locations. Original death-event counts, five-year observed populations and risk sets, censoring and follow-up losses by arm are absent from the summary.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Original materials disclosing deaths, observation and censoring flows for the same allocated population.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original allocation and analysis denominators of 500 randomized participants and ITT 500 (250/250) are preserved. Original 5-year OS of 80%/72% and HR are results from the same trial.", "condition_status": "Unverified", "status_reason": "Required direct details were not verified within the current preserved-summary and externally unread scope. Original death-event counts, five-year observed populations and risk sets, censoring and follow-up losses by arm are absent from the summary. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Original death-event counts, five-year observed populations and risk sets, censoring and follow-up losses by arm are absent from the summary.", "uncertainty": "Original death-event counts, five-year observed populations and risk sets, censoring and follow-up losses by arm are absent from the summary.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables for OS events, risk sets, censoring, and follow-up and analysis denominators." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How do all-cause, cancer-specific and treatment-related deaths differ?", "needed": "Original OS and cause-of-death tables, with separate materials for the 30-day safety window.", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How do all-cause, cancer-specific and treatment-related deaths differ.", "application_exception": "The 1 versus 2 deaths are not substituted for total OS death counts, and no new cause-specific counts are created.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How do all-cause, cancer-specific and treatment-related deaths differ\" to their original locations. Cancer-specific and other cause-specific deaths, total OS event counts, attribution assessment and detailed follow-up are unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, H01, E09.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Materials from the same trial separately defining all-cause, cause-specific and safety deaths.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Original OS concerns all-cause death. The separate safety record of 1 versus 2 deaths within 30 days of treatment completion, all unrelated to treatment, is not moved to total OS events.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Cancer-specific and other cause-specific deaths, total OS event counts, attribution assessment and detailed follow-up are unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Cancer-specific and other cause-specific deaths, total OS event counts, attribution assessment and detailed follow-up are unverified.", "uncertainty": "Cancer-specific and other cause-specific deaths, total OS event counts, attribution assessment and detailed follow-up are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original OS and cause-of-death tables, with separate materials for the 30-day safety window." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What is the scope of OS death verification and measurement without masking?", "needed": "Original procedures for OS death verification, follow-up, missingness, assessment and censoring.", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the scope of OS death verification and measurement without masking.", "application_exception": "An objective death endpoint alone does not certify complete verification, absence of bias or a new B0.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the scope of OS death verification and measurement without masking\" to their original locations. Death-verification routes, missingness and follow-up, central verification, assessor access and between-arm differences in verification are unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E03.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Materials disclosing OS verification methods and limitations for the same trial.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original trial had no blinding or masking, and OS concerns death from any cause. The original objective event is distinguished from the actual verification procedure.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Death-verification routes, missingness and follow-up, central verification, assessor access and between-arm differences in verification are unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Death-verification routes, missingness and follow-up, central verification, assessor access and between-arm differences in verification are unverified.", "uncertainty": "Death-verification routes, missingness and follow-up, central verification, assessor access and between-arm differences in verification are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original procedures for OS death verification, follow-up, missingness, assessment and censoring." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What are the details of OS ITT, censoring and time origin?", "needed": "OS SAP, censoring and missingness, populations at risk, models and sensitivity materials.", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the details of OS ITT, censoring and time origin.", "application_exception": "Time origin, administrative end, follow-up loss, censoring assumptions, proportional hazards, subsequent treatment and sensitivity analyses are unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the details of OS ITT, censoring and time origin\" to their original locations. Time origin, administrative end, follow-up loss, censoring assumptions, proportional hazards, subsequent treatment and sensitivity analyses are unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E04, C07.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Materials from the same trial specifying original OS follow-up and censoring rules and sensitivity analyses.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original quotation states ITT analysis and censoring of event-free patients at the last known alive date. Inclusion in the analysis population is distinguished from actual follow-up and censoring.", "condition_status": "Unverified", "status_reason": "Required direct details were not verified within the current preserved-summary and externally unread scope. Time origin, administrative end, follow-up loss, censoring assumptions, proportional hazards, subsequent treatment and sensitivity analyses are unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Time origin, administrative end, follow-up loss, censoring assumptions, proportional hazards, subsequent treatment and sensitivity analyses are unverified.", "uncertainty": "Time origin, administrative end, follow-up loss, censoring assumptions, proportional hazards, subsequent treatment and sensitivity analyses are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "OS SAP, censoring and missingness, populations at risk, models and sensitivity materials." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What are the reported intervals, absolute importance and joint testing criteria?", "needed": "Definitions of OS importance, joint testing and sample assumptions, and original intervals.", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the reported intervals, absolute importance and joint testing criteria.", "application_exception": "Positive P, parent B or a large sample is not used to guarantee clinical benefit of every magnitude or an individual outcome.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the reported intervals, absolute importance and joint testing criteria\" to their original locations. Justified important differences, event counts and power, joint alpha, effects of the sample change and proportion CI are unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E05, E06.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If the actual plan is supplied, materials linking importance to intervals and plan changes.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Original OS HR/95% CI and the 5-year proportion/8%p statements are separate estimates. Parent B76 is a historical verdict, not the original plan's importance or multiplicity criteria themselves.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Justified important differences, event counts and power, joint alpha, effects of the sample change and proportion CI are unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Justified important differences, event counts and power, joint alpha, effects of the sample change and proportion CI are unverified.", "uncertainty": "Justified important differences, event counts and power, joint alpha, effects of the sample change and proportion CI are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions of OS importance, joint testing and sample assumptions, and original intervals." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "How is PFS from the same trial reported differently from OS?", "needed": "Separate definitions, timepoints, populations, models and original result tables for PFS and OS.", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How is PFS from the same trial reported differently from OS.", "application_exception": "PFS values or intervals are not moved to OS, and outcomes or patients are not added to create independent replication or new participant counts.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How is PFS from the same trial reported differently from OS\" to their original locations. PFS progression and death components, assessment, risk sets and event overlap with OS are unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, C08, E09.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Materials from the same trial disclosing separate analyses for the two coprimary outcomes.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The PFS sheet's 5-year PFS of 72% versus 64%, HR 0.65 (95% CI 0.46–0.91), P=.013 is a separate coprimary result. Original progression or death and investigator-assessed PFS measurement are distinguished from OS.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. PFS progression and death components, assessment, risk sets and event overlap with OS are unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "PFS progression and death components, assessment, risk sets and event overlap with OS are unverified.", "uncertainty": "PFS progression and death components, assessment, risk sets and event overlap with OS are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate definitions, timepoints, populations, models and original result tables for PFS and OS." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Does the OS result also answer questions about symptoms, quality of life and applicability to every population?", "needed": "Other patient-centered and long-term outcomes, subgroups and applicability materials separate from survival.", "role": "Supplementary; required for extension", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Does the OS result also answer questions about symptoms, quality of life and applicability to every population.", "application_exception": "Increased OS does not automatically extend to every symptom, sequela, patient satisfaction or individual benefit in every stage or treatment combination.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Does the OS result also answer questions about symptoms, quality of life and applicability to every population\" to their original locations. Direct values, timepoints and denominators for these outcomes, individual preferences and effects in separate selected populations are unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E09, E08.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If appropriate direct materials are supplied, a text distinguishing OS from separate patient outcomes and population scope.", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Positive selected OS and PFS are preserved as original results. Patient-reported symptoms, quality of life, long-term function, sequelae and other populations are separate questions.", "condition_status": "Unverified", "status_reason": "Required direct details were not verified within the current preserved-summary and externally unread scope. Direct values, timepoints and denominators for these outcomes, individual preferences and effects in separate selected populations are unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Direct values, timepoints and denominators for these outcomes, individual preferences and effects in separate selected populations are unverified.", "uncertainty": "Direct values, timepoints and denominators for these outcomes, individual preferences and effects in separate selected populations are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Other patient-centered and long-term outcomes, subgroups and applicability materials separate from survival." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What are the people, denominators and proportions for grade 3 or worse adverse events?", "needed": "Original safety tables, populations, periods, classification/overlap and comparative statistics", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are the people, denominators and proportions for grade 3 or worse adverse events.", "application_exception": "No new risk difference, ratio, CI, significance or individual harm incidence is calculated beyond the original 11%p.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are the people, denominators and proportions for grade 3 or worse adverse events\" to their original locations. Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H01, H03, H04.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Link severe adverse events in the same exposed population to definitions, denominators and periods", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original counterview records 147/250 (59%) versus 120/250 (48%), an 11%p increase. These original numbers are safety results for the same strategy, with endpoints separate from efficacy/survival.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.", "uncertainty": "Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety tables, populations, periods, classification/overlap and comparative statistics" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What window and relatedness apply to deaths within 30 days of treatment completion?", "needed": "Original treatment-completion, 30-day window, cause/relatedness and denominator tables", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What window and relatedness apply to deaths within 30 days of treatment completion.", "application_exception": "The historical absence of treatment-related deaths within 30 days is not changed to a safety guarantee for every time or harm.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What window and relatedness apply to deaths within 30 days of treatment completion\" to their original locations. Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H02, H04, H09.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use original materials disclosing the limited safety window separately from deaths across full follow-up", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original study-condition description records 1 versus 2 deaths within 30 days of treatment completion, all unrelated to treatment. This is relatedness wording within a limited original window.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.", "uncertainty": "Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original treatment-completion, 30-day window, cause/relatedness and denominator tables" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are individual original results available for marrow suppression, infection and neuropathy?", "needed": "Original adverse-event type tables, definitions, collection/timing and denominators", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Are individual original results available for marrow suppression, infection and neuropathy.", "application_exception": "Original toxicity examples are not asserted to be observed events or rates in particular individuals, and no new user instructions for management or administration are written.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Are individual original results available for marrow suppression, infection and neuropathy\" to their original locations. Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H04, E10.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use original materials reporting type-specific safety under the same study exposure", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original safety description mentions chemotherapy-toxicities such as marrow suppression, infection and neuropathy. Individual event counts/proportions for these types are not provided in the summary.", "condition_status": "Unverified", "status_reason": "Required direct details were not verified within the current preserved-summary and externally unread scope. Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.", "uncertainty": "Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original adverse-event type tables, definitions, collection/timing and denominators" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What are safety-exposure, onset/recovery and stopping times?", "needed": "Phase-specific safety windows, exposure/stopping/recovery and arm-specific materials", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What are safety-exposure, onset/recovery and stopping times.", "application_exception": "The median efficacy follow-up of 67 months is not repurposed as the observation or exposure duration for every harm.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What are safety-exposure, onset/recovery and stopping times\" to their original locations. Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H02, H04.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Link period-specific harms to treatment delivery under the same strategy", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "6 weeks of induction, a median 7-day interval to CCRT, median follow-up of 67 months and 30 days after treatment completion are distinct original time contexts. The entire severe-adverse-event collection window is separately needed.", "condition_status": "Unverified", "status_reason": "Required direct details were not verified within the current preserved-summary and externally unread scope. Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.", "uncertainty": "Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Phase-specific safety windows, exposure/stopping/recovery and arm-specific materials" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "How are original disease, CCRT, concomitant treatment and harm attribution distinguished?", "needed": "Baseline risk, phase/concomitant exposure, event attribution and analysis materials", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are original disease, CCRT, concomitant treatment and harm attribution distinguished.", "application_exception": "Original proportions for the combined strategy are not changed to harm or harmlessness of a particular drug alone, or instructions for adjustment.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are original disease, CCRT, concomitant treatment and harm attribution distinguished\" to their original locations. Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H05, E02, E10.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use original safety materials distinguishing combined exposure and alternative causes", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Locally advanced cervical cancer and the two-drug-plus-CCRT sequence are original study conditions. Severe adverse events compare combined strategies; causal contributions form a separate question.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.", "uncertainty": "Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline risk, phase/concomitant exposure, event attribution and analysis materials" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What is the scope of safety omissions, dropout and selective follow-up?", "needed": "Safety-analysis definitions, flow/missingness and event collection/detection", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the scope of safety omissions, dropout and selective follow-up.", "application_exception": "Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified. Unverified scope is kept separately; no values or verdicts beyond the preserved summary are generated.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the scope of safety omissions, dropout and selective follow-up\" to their original locations. Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H06, H04, C07.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Use same-trial reports/appendices specifying actual omissions and safety follow-up", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Original wording records ITT500 and severe adverse events of 147/250 versus 120/250. Each original denominator is preserved, without equating it to complete collection of all events at all times.", "condition_status": "Unverified", "status_reason": "Required direct details were not verified within the current preserved-summary and externally unread scope. Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.", "uncertainty": "Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety-analysis definitions, flow/missingness and event collection/detection" }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Do long-term, rare and vulnerable-population harms require separate direct materials?", "needed": "Long-term/rare/population-specific safety, exposure/follow-up and direct comparisons", "role": "Supplementary; required for that extension", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Do long-term, rare and vulnerable-population harms require separate direct materials.", "application_exception": "Events not specified here are not filled in as zero or no occurrence.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Do long-term, rare and vulnerable-population harms require separate direct materials\" to their original locations. Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H08, E08.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If suitable materials for these scopes are supplied, distinguish them from the currently selected effects/harms", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "5-year survival outcomes and median follow-up of 67 months concern efficacy follow-up. The original records severe toxicity and a limited 30-day death window but does not supply all long-term, rare or population-specific harms.", "condition_status": "Unverified", "status_reason": "Required direct details were not verified within the current preserved-summary and externally unread scope. Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.", "uncertainty": "Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term/rare/population-specific safety, exposure/follow-up and direct comparisons" }, { "item_id": "N38", "question_type": "Evidence condition", "question": "Where was original public/nonprofit funding reported?", "needed": "Original funding/COI, sponsor/author-role declarations and data access", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Where was original public/nonprofit funding reported.", "application_exception": "Public or nonprofit funding and original I2 alone do not certify current independence, absence of bias or absence of all conflicts of interest.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Where was original public/nonprofit funding reported\" to their original locations. Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: Link complete original declarations of actual funding, roles and disclosures", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Cancer Research UK and University College London–UCLH Biomedical Research Centre support is recorded in the original funding and research descriptions. Parent I2 remains a historical axis.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.", "uncertainty": "Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding/COI, sponsor/author-role declarations and data access" }, { "item_id": "N39", "question_type": "Evidence condition", "question": "What is the scope of no reported company provision of free study drugs?", "needed": "Study-drug/in-kind supply and original interest/role declarations", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the scope of no reported company provision of free study drugs.", "application_exception": "A statement that something was not reported is not changed to current certification of no involvement or provision by any company.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the scope of no reported company provision of free study drugs\" to their original locations. Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If original declarations are supplied, distinguish unreported matters from actual absence or provision", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The original research description states that free company study-drug provision was not reported. This is historical parent-authoring wording and does not establish current products or complete contracts.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.", "uncertainty": "Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-drug/in-kind supply and original interest/role declarations" }, { "item_id": "N40", "question_type": "Evidence condition", "question": "How are independent replication and the two coprimary outcomes distinguished?", "needed": "Family relationships among reports, trials, populations, exact strategies, sources, outcomes and harms", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are independent replication and the two coprimary outcomes distinguished.", "application_exception": "The original absence of replication is not changed to zero current studies worldwide, and two tables or endpoints are not counted as new independent replications.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are independent replication and the two coprimary outcomes distinguished\" to their original locations. Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If additional materials are supplied, link shared/separate trials and state the level at which independence was verified", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The parent preserves the historical statement that the same strategy lacked independent replication and records R1. Positive PFS/OS are results from the same INTERLACE trial, rather than two separate confirmatory trials.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search.", "uncertainty": "Current independent materials for the same strategy, additional/follow-up reports, other-family lists and reuse of the same events remain undetermined without a new search.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Family relationships among reports, trials, populations, exact strategies, sources, outcomes and harms" }, { "item_id": "N41", "question_type": "Evidence condition", "question": "What is the context of null OUTBACK/ACTLACC results under a different sequence?", "needed": "Original study citations, exact sequences, populations, comparisons, results and same-strategy scope", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: What is the context of null OUTBACK/ACTLACC results under a different sequence.", "application_exception": "Names alone do not create additional report entries or new independent trials, or establish direct superiority of one sequence over another or optimal timing.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"What is the context of null OUTBACK/ACTLACC results under a different sequence\" to their original locations. Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, C02, E07, E08.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If relevant materials are supplied, distinguish sequencing scope without automatically treating it as direct refutation or superiority", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "The parent's research description/counterpoint states that post-radiation adjuvant chemotherapy in OUTBACK and ACTLACC did not improve survival and concerns a different sequencing question. They are not separate evidence/citation entries in this preserved summary.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.", "uncertainty": "Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original study citations, exact sequences, populations, comparisons, results and same-strategy scope" }, { "item_id": "N42", "question_type": "Evidence condition", "question": "How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved?", "needed": "Separate copies of subclaim/parent values, axes/absences, Korean/English texts and historical verdicts", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved.", "application_exception": "Unrecorded precision is not filled in as zero, and parent scores or axes are not inherited by the subclaim or labeled a newly completed review.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved\" to their original locations. Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09, E06.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If corrections are supplied, distinguish full original text, events/versions and decisions and record parent/subclaim scope", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Parent B76/Caution, original axes B/H/R1/I2/E+/B0, unrecorded precision, coprimary-split false, large-hard-endpoint-RCT true, no-human-study false and empty override reason are preserved unchanged. Korean/English texts, historical synthesis/grade decision and cross-check wording remain parent history.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.", "uncertainty": "Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate copies of subclaim/parent values, axes/absences, Korean/English texts and historical verdicts" }, { "item_id": "N43", "question_type": "Evidence condition", "question": "At what level can survival and toxicity currently be described?", "needed": "Efficacy/safety definitions, denominators/periods, original statistics and extrapolation boundaries", "role": "Required", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: At what level can survival and toxicity currently be described.", "application_exception": "Original increases are not changed to guarantees of individual benefit or harm, and absence of treatment-related deaths within 30 days is not extended to harmlessness.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"At what level can survival and toxicity currently be described\" to their original locations. Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions H09, E10, C08, E09.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If original materials are added, update evidence gaps while distinguishing interpretation across outcomes and times", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "Both positive coprimary survival results, increased severe toxicity and the limited 30-day relatedness result are preserved within original scope. Parent Caution remains history and establishes neither personal treatment decisions nor safety certification.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.", "uncertainty": "Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Efficacy/safety definitions, denominators/periods, original statistics and extrapolation boundaries" }, { "item_id": "N44", "question_type": "Evidence condition", "question": "Is extrapolation to current treatment, dose or radiotherapy choices avoided?", "needed": "Direct population/exposure/comparator, periods and effect/harm materials for extended questions", "role": "Supplementary; required for extension of applicability", "role_reason": "This condition is needed to separately document the selected five-year overall-survival question: Is extrapolation to current treatment, dose or radiotherapy choices avoided.", "application_exception": "No new instructions are created for carboplatin or paclitaxel, dose calculation or administration, CCRT or radiotherapy schedules, treatment selection or substitution, suitability or management actions.", "criterion": "Link preserved values, definitions, denominators, periods and unverified matters relevant to \"Is extrapolation to current treatment, dose or radiotherapy choices avoided\" to their original locations. Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.", "basis": "Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, E08, H08, H09.", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Proposal: If materials are supplied and scope authorized, update while distinguishing original materials from other application conditions", "current_reports": [ "R01" ], "existence": "Related statements exist in the preserved JSON summary; existence and acquisition of detailed original materials are unverified.", "acquired_read": "Summary read; external materials not read", "observation": "This table presents the designated existing INTERLACE question and historical combination strategy, population, comparator, original values and gaps. Current individual treatment/suitability and other products/doses/sequences/techniques are separate questions.", "condition_status": "Partly verified", "status_reason": "Some preserved-summary information has been linked. Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified. Existing content review remains incomplete; this does not establish clinical-condition fulfillment, zero effect or absence of materials.", "missingness": "Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.", "uncertainty": "Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct population/exposure/comparator, periods and effect/harm materials for extended questions" } ], "reports": [ { "report_id": "R01", "title": "McCormack M, Eminowicz G, Gallardo D, et al. Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE). Lancet. 2024;404:1525-1535. PMID: 39419054.", "url": "https://pubmed.ncbi.nlm.nih.gov/39419054/", "report_type": "Original summary of the same report from the international multicenter randomized phase 3 INTERLACE trial.", "existence": "Report records in the preserved summary's evidence/citation lists", "acquired_read": "Summary read; external abstracts, full papers and registries unread", "study_family": "F01", "independent_replication": false, "observed_result": "OS HR 0.60 (95% CI 0.40–0.91), P=.015 appears in the original rationale and reader answer. The OS interval in the evidence list is preserved without a confidence-level label. Each location is linked separately.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Complete preserved copy of the original summary", "access_status": "Preserved summary copy acquired; summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T18:23:35.242204+09:00", "qualification": "The full parent record, two existing questions, Korean and English texts, and original values, bibliographic details and registry records were read for production. This was not reading the original paper or registry." }, { "material_type": "External abstract", "public_status": "External materials unread; access not attempted", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PubMed bibliographic URL is retained; the abstract was not acquired or read, and the link was not tested." }, { "material_type": "External full text", "public_status": "External materials unread; access not attempted", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The existing link connects bibliographic identity and does not certify full-text access or acquisition. Original plans, results, measurements and safety tables are needed." }, { "material_type": "External registration", "public_status": "External materials unread; access not attempted", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Existing NCT01566240 and EudraCT 2011-001300-35 records and original statements of agreement are preserved; no URL absent from the existing review summary is created or accessed, and no date is inferred." }, { "material_type": "Required protocol", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans and versions are needed for eligibility, nominal and actual treatment, measurement, co-primary endpoints and timepoints, and the change from 700 to 500." }, { "material_type": "Required analysis plan", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original materials are needed for models and adjustment, joint alpha and multiplicity, censoring, populations at risk, sensitivity analyses and importance thresholds. No new intervals or numbers are generated." }, { "material_type": "Required result tables and safety material", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original tables are needed for the five-year risk set and events, treatment delivery, safety by grade and time, the 30-day death window and attribution, follow-up and missingness." }, { "material_type": "Required funding and interests", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Public or nonprofit funding and unreported company-provided trial drugs are historical summary statements. Complete funding and product provision, contracts, author conflicts of interest, and design and publication roles remain unread." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/39419054/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Existing content review is pending or remains incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The two outcome tables share GCIG INTERLACE, PMID 39419054, NCT01566240 / EudraCT 2011-001300-35, 500 participants with 250 per arm, and follow-up of 67 months. PFS, OS, harms and the 30-day window are outcome-specific units and are not summed as independent evidence. OUTBACK and ACTLACC are retained only as named context in the preserved summary; no separate bibliographic entries or tables are created." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }