# INTERLACE induction carboplatin and paclitaxel · Locally advanced cervical cancer · Evidence checklist for increased five-year overall survival

Verdict 2936 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-10

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: Locally advanced cervical cancer; INTERLACE, 500 participants at 32 centers. Exact stage, age, eligibility and baseline characteristics are unverified.
- Ingredient, formulation and route: 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.
- Measured outcome: 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.
- Questions outside this scope: 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.

## Checklist items

### N01 · What are the selected question, verdict record and parent context?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.
- Required materials and conditions: Original question/record and links to parent/related outcomes
- Materials to obtain first: Original question/record and links to parent/related outcomes
- Further research: Proposal: If new materials for the same question are supplied, link them while preserving the existing record and original wording
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.
- Referenced methods: Own question-specific application conditions informed by the preserved summary and family definition C01.
- Related sources: R01

### N02 · How are original subclaim B/note, parent B76 and absent score/axes separated?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: There are no direct values for the selected subclaim score, status or axes.
- Required materials and conditions: A preserved copy separating the subclaim verdict/note from parent score/axes
- Materials to obtain first: A preserved copy separating the subclaim verdict/note from parent score/axes
- Further research: Proposal: If a subclaim correction is actually supplied, record the complete original text, event and change decision separately
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: There are no direct values for the selected subclaim score, status or axes.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09.
- Related sources: R01

### N03 · Do both tables, PFS, OS and safety concern the same trial?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.
- Required materials and conditions: Relationships among reports, registration, trial families, outcomes/time points and shared populations
- Materials to obtain first: Relationships among reports, registration, trial families, outcomes/time points and shared populations
- Further research: Proposal: If follow-up or other materials are supplied, distinguish shared reports/populations/outcomes from separate families
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The two questions, survival curves, endpoints, centers or 500 participants with 250 per arm are not added as new independent replications or participants.
- Remaining uncertainty: Additional versions/reports, current unique trial/person totals and an external replication list for the same strategy remain undetermined.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.
- Related sources: R01

### N04 · Which preserved summary and external original materials have currently been read?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: External availability/acquisition, current content, link operation and access success were not verified in this work.
- Required materials and conditions: Existence, acquisition, reading status and original locations of the preserved summary and external materials
- Materials to obtain first: Existence, acquisition, reading status and original locations of the preserved summary and external materials
- Further research: Proposal: When obtaining follow-up materials is authorized, record actual reading level and distinguish historical from current dates
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External availability/acquisition, current content, link operation and access success were not verified in this work.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C03.
- Related sources: R01

### N05 · What were the actual population and selection scope for locally advanced cervical cancer?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.
- Required materials and conditions: Original eligibility/exclusion, stage and baseline-characteristic tables
- Materials to obtain first: Original eligibility/exclusion, stage and baseline-characteristic tables
- Further research: Proposal: Use materials from the same trial specifying original recruitment conditions, or suitable separate population research
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Stage classification/version, age, histology, lymph nodes, comorbidities, prior treatment, eligibility/exclusions and baseline risk remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E08.
- Related sources: R01

### N06 · What do 32 centers, the international multicenter design and population distribution describe?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.
- Required materials and conditions: Center/region and recruitment distribution, baseline balance and treatment-delivery materials
- Materials to obtain first: Center/region and recruitment distribution, baseline balance and treatment-delivery materials
- Further research: Proposal: Use supplementary same-trial materials reporting actual regional conditions and results
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The 32 centers are not labeled independent trials, and no country list or distribution is invented.
- Remaining uncertainty: Country/center-specific counts, treatment resources, regional baseline/results and recruitment changes are absent from the summary.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C04, E01, E07.
- Related sources: R01

### N07 · What are the sequence of induction chemotherapy before radiation and the comparator strategy?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.
- Required materials and conditions: Original protocols, shared treatment, sequencing and delivery for both strategies
- Materials to obtain first: Original protocols, shared treatment, sequencing and delivery for both strategies
- Further research: Proposal: Use reports/appendices defining the original comparison of induction addition and standard CCRT
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The study sequence is not written as an individual treatment plan, treatment selection or guidance for another sequence.
- Remaining uncertainty: Detailed CCRT chemotherapy/radiotherapy schedules, actual between-arm balance and complete treatment-completion data remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02.
- Related sources: R01

### N08 · How are nominal induction exposure and actual administered amounts separated?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.
- Required materials and conditions: Original nominal/actual exposure, changes, adherence, formulation and route materials
- Materials to obtain first: Original nominal/actual exposure, changes, adherence, formulation and route materials
- Further research: Proposal: Link actual administration/stopping and results from the same study
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Formulation/route, actual cumulative amounts, reductions, omissions, stopping, adherence and each drug's contribution remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.
- Related sources: R01

### N09 · What was the median interval from induction completion to CCRT?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.
- Required materials and conditions: Original interval, delay, non-delivery, actual schedule and completion tables
- Materials to obtain first: Original interval, delay, non-delivery, actual schedule and completion tables
- Further research: Proposal: Link same-study sequencing, interval distributions and treatment delivery
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The median seven-day interval is not turned into an identical interval for every participant or a recommendation on when to start treatment.
- Remaining uncertainty: Individual intervals, range/variation, reasons for delay, non-delivery/stopping and arm-specific actual treatment starts remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C05, E02, E08.
- Related sources: R01

### N10 · What were the randomized/ITT denominators and arm allocations?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.
- Required materials and conditions: Allocation-to-exposure-to-analysis flow and endpoint/time-specific safety denominators
- Materials to obtain first: Allocation-to-exposure-to-analysis flow and endpoint/time-specific safety denominators
- Further research: Proposal: Distinguish analysis, risk sets and actual exposure within the same allocated population
- Conditions for verification: 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.
- Why this condition is needed: This condition is needed to separately document the selected five-year overall-survival question: What were the randomized/ITT denominators and arm allocations.
- Application exceptions: 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.
- Remaining uncertainty: Time-specific risk sets, missingness/censoring and actual exposure/safety/imaging-assessment denominators require separate original tables.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.
- Related sources: R01

### N11 · What were allocation, concealment and baseline balance?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original quote states, 'Allocation was done by minimisation, using a central electronic system'. The central-electronic-system minimisation record is preserved.
- Why unverified: 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.
- Reason for missing information: Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.
- Required materials and conditions: Allocation algorithm/concealment, operational roles and baseline tables
- Materials to obtain first: Allocation algorithm/concealment, operational roles and baseline tables
- Further research: Proposal: Use plans/original reports disclosing actual allocation procedures
- Conditions for verification: 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.
- Why this condition is needed: This condition is needed to separately document the selected five-year overall-survival question: What were allocation, concealment and baseline balance.
- Application exceptions: 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.
- Remaining uncertainty: Original details of minimisation variables, random components, sequence access/operation and baseline balance remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01.
- Related sources: R01

### N12 · What is the scope of no masking and investigator-assessed PFS?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.
- Required materials and conditions: Endpoint-specific measurement, assessors, masking/confirmation, schedules and original appendices
- Materials to obtain first: Endpoint-specific measurement, assessors, masking/confirmation, schedules and original appendices
- Further research: Proposal: Link same-trial PFS and OS measurement limitations to each outcome
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Details of imaging/assessment procedures for progression, time points, central review, death confirmation and assessment differences remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E01, E03.
- Related sources: R01

### N13 · What are the original ITT and censoring records for event-free patients?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original statement 'Analyses were by intention-to-treat (ITT)' and censoring of event-free patients at the last known alive date are preserved.
- Why unverified: 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.
- Reason for missing information: Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.
- Required materials and conditions: Endpoint-specific ITT/censoring, missingness, sensitivity and analysis-population definitions
- Materials to obtain first: Endpoint-specific ITT/censoring, missingness, sensitivity and analysis-population definitions
- Further research: Proposal: Link event/censoring/loss flow and original analysis from the same trial
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Original ITT and censoring statements are not labeled complete follow-up of every participant or completed current statistical review.
- Remaining uncertainty: Detailed censoring, administrative end, follow-up loss, sensitivity and independent-censoring assumptions for PFS/OS remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.
- Related sources: R01

### N14 · How were adherence, supportive/follow-up treatment and treatment changes handled?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.
- Required materials and conditions: Actual arm-specific treatment, follow-up/salvage treatment, adherence and handling
- Materials to obtain first: Actual arm-specific treatment, follow-up/salvage treatment, adherence and handling
- Further research: Proposal: Use original reports distinguishing allocated-strategy effects from actual treatment delivery
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Arm-specific completion, dose reductions/stopping, subsequent chemotherapy, salvage treatment, concomitant supportive therapy and analysis handling remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E02, E04.
- Related sources: R01

### N15 · What were coprimary PFS/OS and the registration history?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.
- Required materials and conditions: Original NCT/EudraCT versions, protocol, SAP and coprimary endpoint/time-point comparisons
- Materials to obtain first: Original NCT/EudraCT versions, protocol, SAP and coprimary endpoint/time-point comparisons
- Further research: Proposal: If original plans are supplied, link coprimary endpoints, amendment times and reporting scope
- Conditions for verification: 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.
- Why this condition is needed: This condition is needed to separately document the selected five-year overall-survival question: What were coprimary PFS/OS and the registration history.
- Application exceptions: Registry IDs and original statements of agreement are not upgraded to registry access during this work or certification of prespecification.
- Remaining uncertainty: Initial/amended registration versions, original protocol/SAP, joint-testing rules and reporting changes remain unread.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, C09.
- Related sources: R01

### N16 · Why did the planned sample change from 700 to 500?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.
- Required materials and conditions: Original sample/planning changes, events, approvals, statistical assumptions and versions
- Materials to obtain first: Original sample/planning changes, events, approvals, statistical assumptions and versions
- Further research: Proposal: Use original reports/plans specifying recruitment/planning changes and final-analysis scope
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Original amendment dates, procedures/approvals, power/event redesign and SAP/registration-version details remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E06, E05, C07.
- Related sources: R01

### N17 · Do median follow-up of 67 months, five-year outcomes and exposure duration differ?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.
- Required materials and conditions: Follow-up distributions, data cutoff, risk sets and time-specific tables
- Materials to obtain first: Follow-up distributions, data cutoff, risk sets and time-specific tables
- Further research: Proposal: Use original same-trial materials clarifying follow-up and each endpoint's time points
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The 67 months are not labeled every participant's follow-up duration or treatment duration.
- Remaining uncertainty: Follow-up range, cutoff date, minimum/maximum, time-specific risk sets and exposure/safety observation periods remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, H02.
- Related sources: R01

### N18 · Are between-arm HR/five-year proportions distinguished from within-arm change and adjustment?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.
- Required materials and conditions: SAP, statistical models, definitions of each estimate/interval and original tables
- Materials to obtain first: SAP, statistical models, definitions of each estimate/interval and original tables
- Further research: Proposal: Link original models, adjustment, assumptions and between-arm results
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: HR models, adjustment/stratification variables, assumptions, survival-proportion methods, sensitivity and multiplicity remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.
- Related sources: R01

### N19 · Can direct effects of dose, sequence and subgroups be stated?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.
- Required materials and conditions: Direct comparisons, prespecified subgroups, interactions and actual exposure materials
- Materials to obtain first: Direct comparisons, prespecified subgroups, interactions and actual exposure materials
- Further research: Proposal: If suitable direct comparisons specifying population/exposure are supplied, distinguish them from the original strategy
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Results for the combined two-drug sequence are not attributed to either drug alone or to a confirmed optimal dose or interval.
- Remaining uncertainty: Direct dose/interval comparisons, drug separation, prespecified subgroups/interactions and adherence effects remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E08, E02.
- Related sources: R01

### N20 · How are report/registration history, original evidence date and current production date separated?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.
- Required materials and conditions: Publication/registration changes, evidence date, search/correction history and production events
- Materials to obtain first: Publication/registration changes, evidence date, search/correction history and production events
- Further research: Proposal: If materials are supplied, preserve original versions and additional dates/correction events separately
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Original evidence-cutoff/classification values are absent; current registration/corrections/retractions and additional-search comparison were not performed.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, C03.
- Related sources: R01

### N21 · What are the event definition and coprimary hierarchy for the selected OS?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Detailed OS time origin, death verification, original censoring and follow-up, and joint testing rules are unverified.
- Required materials and conditions: Original OS definition, time origin, verification, coprimary hierarchy and SAP materials.
- Materials to obtain first: Original OS definition, time origin, verification, coprimary hierarchy and SAP materials.
- Further research: Proposal: Original materials disclosing the actual OS definition and analysis and joint plans for the same trial.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Detailed OS time origin, death verification, original censoring and follow-up, and joint testing rules are unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E06, E04.
- Related sources: R01

### N22 · What original timepoint and unit do the 5-year OS values of 80% versus 72% represent?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Estimation method, CI, populations at risk, follow-up and censoring, and data cutoff for the five-year proportions are unverified.
- Required materials and conditions: Original tables for 5-year OS proportions and CI, populations at risk, curves and cutoff.
- Materials to obtain first: Original tables for 5-year OS proportions and CI, populations at risk, curves and cutoff.
- Further research: Proposal: Original materials defining proportions and time-to-event results together for the same OS.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: No new difference, NNT, survival months, survivor count or death count is calculated beyond the original 8%p.
- Remaining uncertainty: Estimation method, CI, populations at risk, follow-up and censoring, and data cutoff for the five-year proportions are unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, E05.
- Related sources: R01

### N23 · What are the original OS HR, 95% CI, P and direction?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: HR model, adjustment and stratification, proportional-hazards assumptions, testing plan and absolute importance thresholds are unverified.
- Required materials and conditions: Original OS HR and intervals, SAP, models and test definitions.
- Materials to obtain first: Original OS HR and intervals, SAP, models and test definitions.
- Further research: Proposal: Materials linking original analysis assumptions and plans to the reported interval.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: HR model, adjustment and stratification, proportional-hazards assumptions, testing plan and absolute importance thresholds are unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, E04, E05.
- Related sources: R01

### N24 · What are the direct values for OS deaths, the 5-year population at risk and denominators?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original death-event counts, five-year observed populations and risk sets, censoring and follow-up losses by arm are absent from the summary.
- Required materials and conditions: Original tables for OS events, risk sets, censoring, and follow-up and analysis denominators.
- Materials to obtain first: Original tables for OS events, risk sets, censoring, and follow-up and analysis denominators.
- Further research: Proposal: Original materials disclosing deaths, observation and censoring flows for the same allocated population.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Original death-event counts, five-year observed populations and risk sets, censoring and follow-up losses by arm are absent from the summary.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C07, E04.
- Related sources: R01

### N25 · How do all-cause, cancer-specific and treatment-related deaths differ?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Cancer-specific and other cause-specific deaths, total OS event counts, attribution assessment and detailed follow-up are unverified.
- Required materials and conditions: Original OS and cause-of-death tables, with separate materials for the 30-day safety window.
- Materials to obtain first: Original OS and cause-of-death tables, with separate materials for the 30-day safety window.
- Further research: Proposal: Materials from the same trial separately defining all-cause, cause-specific and safety deaths.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The 1 versus 2 deaths are not substituted for total OS death counts, and no new cause-specific counts are created.
- Remaining uncertainty: Cancer-specific and other cause-specific deaths, total OS event counts, attribution assessment and detailed follow-up are unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C06, C07, H01, E09.
- Related sources: R01

### N26 · What is the scope of OS death verification and measurement without masking?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Death-verification routes, missingness and follow-up, central verification, assessor access and between-arm differences in verification are unverified.
- Required materials and conditions: Original procedures for OS death verification, follow-up, missingness, assessment and censoring.
- Materials to obtain first: Original procedures for OS death verification, follow-up, missingness, assessment and censoring.
- Further research: Proposal: Materials disclosing OS verification methods and limitations for the same trial.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: An objective death endpoint alone does not certify complete verification, absence of bias or a new B0.
- Remaining uncertainty: Death-verification routes, missingness and follow-up, central verification, assessor access and between-arm differences in verification are unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E03.
- Related sources: R01

### N27 · What are the details of OS ITT, censoring and time origin?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Time origin, administrative end, follow-up loss, censoring assumptions, proportional hazards, subsequent treatment and sensitivity analyses are unverified.
- Required materials and conditions: OS SAP, censoring and missingness, populations at risk, models and sensitivity materials.
- Materials to obtain first: OS SAP, censoring and missingness, populations at risk, models and sensitivity materials.
- Further research: Proposal: Materials from the same trial specifying original OS follow-up and censoring rules and sensitivity analyses.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Time origin, administrative end, follow-up loss, censoring assumptions, proportional hazards, subsequent treatment and sensitivity analyses are unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E04, C07.
- Related sources: R01

### N28 · What are the reported intervals, absolute importance and joint testing criteria?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Justified important differences, event counts and power, joint alpha, effects of the sample change and proportion CI are unverified.
- Required materials and conditions: Definitions of OS importance, joint testing and sample assumptions, and original intervals.
- Materials to obtain first: Definitions of OS importance, joint testing and sample assumptions, and original intervals.
- Further research: Proposal: If the actual plan is supplied, materials linking importance to intervals and plan changes.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Positive P, parent B or a large sample is not used to guarantee clinical benefit of every magnitude or an individual outcome.
- Remaining uncertainty: Justified important differences, event counts and power, joint alpha, effects of the sample change and proportion CI are unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E05, E06.
- Related sources: R01

### N29 · How is PFS from the same trial reported differently from OS?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: PFS progression and death components, assessment, risk sets and event overlap with OS are unverified.
- Required materials and conditions: Separate definitions, timepoints, populations, models and original result tables for PFS and OS.
- Materials to obtain first: Separate definitions, timepoints, populations, models and original result tables for PFS and OS.
- Further research: Proposal: Materials from the same trial disclosing separate analyses for the two coprimary outcomes.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: PFS values or intervals are not moved to OS, and outcomes or patients are not added to create independent replication or new participant counts.
- Remaining uncertainty: PFS progression and death components, assessment, risk sets and event overlap with OS are unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, C08, E09.
- Related sources: R01

### N30 · Does the OS result also answer questions about symptoms, quality of life and applicability to every population?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Direct values, timepoints and denominators for these outcomes, individual preferences and effects in separate selected populations are unverified.
- Required materials and conditions: Other patient-centered and long-term outcomes, subgroups and applicability materials separate from survival.
- Materials to obtain first: Other patient-centered and long-term outcomes, subgroups and applicability materials separate from survival.
- Further research: Proposal: If appropriate direct materials are supplied, a text distinguishing OS from separate patient outcomes and population scope.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Increased OS does not automatically extend to every symptom, sequela, patient satisfaction or individual benefit in every stage or treatment combination.
- Remaining uncertainty: Direct values, timepoints and denominators for these outcomes, individual preferences and effects in separate selected populations are unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E09, E08.
- Related sources: R01

### N31 · What are the people, denominators and proportions for grade 3 or worse adverse events?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.
- Required materials and conditions: Original safety tables, populations, periods, classification/overlap and comparative statistics
- Materials to obtain first: Original safety tables, populations, periods, classification/overlap and comparative statistics
- Further research: Proposal: Link severe adverse events in the same exposed population to definitions, denominators and periods
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: No new risk difference, ratio, CI, significance or individual harm incidence is calculated beyond the original 11%p.
- Remaining uncertainty: Collection windows, grade criteria, event/person overlap, detailed types, between-arm CI/P and full exposed-population details remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions E10, H01, H03, H04.
- Related sources: R01

### N32 · What window and relatedness apply to deaths within 30 days of treatment completion?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.
- Required materials and conditions: Original treatment-completion, 30-day window, cause/relatedness and denominator tables
- Materials to obtain first: Original treatment-completion, 30-day window, cause/relatedness and denominator tables
- Further research: Proposal: Use original materials disclosing the limited safety window separately from deaths across full follow-up
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The historical absence of treatment-related deaths within 30 days is not changed to a safety guarantee for every time or harm.
- Remaining uncertainty: Treatment-completion denominators, pre-completion events, cause/relatedness procedures and long-term treatment-related events remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H02, H04, H09.
- Related sources: R01

### N33 · Are individual original results available for marrow suppression, infection and neuropathy?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.
- Required materials and conditions: Original adverse-event type tables, definitions, collection/timing and denominators
- Materials to obtain first: Original adverse-event type tables, definitions, collection/timing and denominators
- Further research: Proposal: Use original materials reporting type-specific safety under the same study exposure
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Event definitions, grades, denominators/periods, exposure/arm-specific values and direct dose-reduction/stopping materials remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H01, H04, E10.
- Related sources: R01

### N34 · What are safety-exposure, onset/recovery and stopping times?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.
- Required materials and conditions: Phase-specific safety windows, exposure/stopping/recovery and arm-specific materials
- Materials to obtain first: Phase-specific safety windows, exposure/stopping/recovery and arm-specific materials
- Further research: Proposal: Link period-specific harms to treatment delivery under the same strategy
- Conditions for verification: 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.
- Why this condition is needed: This condition is needed to separately document the selected five-year overall-survival question: What are safety-exposure, onset/recovery and stopping times.
- Application exceptions: The median efficacy follow-up of 67 months is not repurposed as the observation or exposure duration for every harm.
- Remaining uncertainty: Induction/CCRT-phase harms, actual exposure, onset/recovery, stopping/re-exposure and follow-up windows remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H02, H04.
- Related sources: R01

### N35 · How are original disease, CCRT, concomitant treatment and harm attribution distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.
- Required materials and conditions: Baseline risk, phase/concomitant exposure, event attribution and analysis materials
- Materials to obtain first: Baseline risk, phase/concomitant exposure, event attribution and analysis materials
- Further research: Proposal: Use original safety materials distinguishing combined exposure and alternative causes
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Original proportions for the combined strategy are not changed to harm or harmlessness of a particular drug alone, or instructions for adjustment.
- Remaining uncertainty: Drug/radiation-specific attribution, baseline events, concomitant drugs/support, alternative causes and arm-specific adjustment remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H05, E02, E10.
- Related sources: R01

### N36 · What is the scope of safety omissions, dropout and selective follow-up?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.
- Required materials and conditions: Safety-analysis definitions, flow/missingness and event collection/detection
- Materials to obtain first: Safety-analysis definitions, flow/missingness and event collection/detection
- Further research: Proposal: Use same-trial reports/appendices specifying actual omissions and safety follow-up
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Safety-population definitions, event omissions/detection, incomplete treatment, follow-up loss and reporting scope for all types remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H06, H04, C07.
- Related sources: R01

### N37 · Do long-term, rare and vulnerable-population harms require separate direct materials?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.
- Required materials and conditions: Long-term/rare/population-specific safety, exposure/follow-up and direct comparisons
- Materials to obtain first: Long-term/rare/population-specific safety, exposure/follow-up and direct comparisons
- Further research: Proposal: If suitable materials for these scopes are supplied, distinguish them from the currently selected effects/harms
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Events not specified here are not filled in as zero or no occurrence.
- Remaining uncertainty: Sequelae, long-term neurological/reproductive function, rare events, baseline-risk-specific harms and interactions remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H08, E08.
- Related sources: R01

### N38 · Where was original public/nonprofit funding reported?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.
- Required materials and conditions: Original funding/COI, sponsor/author-role declarations and data access
- Materials to obtain first: Original funding/COI, sponsor/author-role declarations and data access
- Further research: Proposal: Link complete original declarations of actual funding, roles and disclosures
- Conditions for verification: 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.
- Why this condition is needed: This condition is needed to separately document the selected five-year overall-survival question: Where was original public/nonprofit funding reported.
- Application exceptions: Public or nonprofit funding and original I2 alone do not certify current independence, absence of bias or absence of all conflicts of interest.
- Remaining uncertainty: Grant identifiers, full funding/contract scope, sponsor design/analysis/submission roles and individual COI remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.
- Related sources: R01

### N39 · What is the scope of no reported company provision of free study drugs?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.
- Required materials and conditions: Study-drug/in-kind supply and original interest/role declarations
- Materials to obtain first: Study-drug/in-kind supply and original interest/role declarations
- Further research: Proposal: If original declarations are supplied, distinguish unreported matters from actual absence or provision
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: A statement that something was not reported is not changed to current certification of no involvement or provision by any company.
- Remaining uncertainty: Original product supply, financial/in-kind provision, author employment/patents and full support roles remain externally unread.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C10.
- Related sources: R01

### N40 · How are independent replication and the two coprimary outcomes distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Family relationships among reports, trials, populations, exact strategies, sources, outcomes and harms
- Materials to obtain first: Family relationships among reports, trials, populations, exact strategies, sources, outcomes and harms
- Further research: Proposal: If additional materials are supplied, link shared/separate trials and state the level at which independence was verified
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C02, E07, H07.
- Related sources: R01

### N41 · What is the context of null OUTBACK/ACTLACC results under a different sequence?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.
- Required materials and conditions: Original study citations, exact sequences, populations, comparisons, results and same-strategy scope
- Materials to obtain first: Original study citations, exact sequences, populations, comparisons, results and same-strategy scope
- Further research: Proposal: If relevant materials are supplied, distinguish sequencing scope without automatically treating it as direct refutation or superiority
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Names alone do not create additional report entries or new independent trials, or establish direct superiority of one sequence over another or optimal timing.
- Remaining uncertainty: Direct citations, registration, populations, exposure, denominators, values and exact comparisons for those trials are absent and remain externally unread.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C08, C02, E07, E08.
- Related sources: R01

### N42 · How are parent axes, false/unrecorded values, Korean/English texts and verdict history preserved?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.
- Required materials and conditions: Separate copies of subclaim/parent values, axes/absences, Korean/English texts and historical verdicts
- Materials to obtain first: Separate copies of subclaim/parent values, axes/absences, Korean/English texts and historical verdicts
- Further research: Proposal: If corrections are supplied, distinguish full original text, events/versions and decisions and record parent/subclaim scope
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Original B0/I2, unrecorded precision and cross-check statements were not reapplied as current selected-subclaim condition fulfillment or completed review.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C01, C09, E06.
- Related sources: R01

### N43 · At what level can survival and toxicity currently be described?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.
- Required materials and conditions: Efficacy/safety definitions, denominators/periods, original statistics and extrapolation boundaries
- Materials to obtain first: Efficacy/safety definitions, denominators/periods, original statistics and extrapolation boundaries
- Further research: Proposal: If original materials are added, update evidence gaps while distinguishing interpretation across outcomes and times
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Harm-comparison CI/P, personal suitability, long-term benefit/harm balance and direct materials for current treatment choices remain unverified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions H09, E10, C08, E09.
- Related sources: R01

### N44 · Is extrapolation to current treatment, dose or radiotherapy choices avoided?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.
- Required materials and conditions: Direct population/exposure/comparator, periods and effect/harm materials for extended questions
- Materials to obtain first: Direct population/exposure/comparator, periods and effect/harm materials for extended questions
- Further research: Proposal: If materials are supplied and scope authorized, update while distinguishing original materials from other application conditions
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Current guidelines/products/regulation, direct superiority over other strategies, individual baseline conditions and latest treatment combinations were not verified.
- Referenced methods: Own question-specific conditions informed by the preserved summary's original locations and family definitions C09, E08, H08, H09.
- Related sources: R01

## Evidence and sources

### R01

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.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/39419054/)

Materials actually read: Summary read; external abstracts, full papers and registries unread  
Findings recorded in the summary: 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.  
Record level: Not recorded  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Complete preserved copy of the original summary | Preserved summary copy acquired; summary read | Summary read | 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. |
| External abstract | External materials unread; access not attempted | Access not attempted; not acquired | Not read | The original PubMed bibliographic URL is retained; the abstract was not acquired or read, and the link was not tested. |
| External full text | External materials unread; access not attempted | Access not attempted; not acquired | Not read | The existing link connects bibliographic identity and does not certify full-text access or acquisition. Original plans, results, measurements and safety tables are needed. |
| External registration | External materials unread; access not attempted | Access not attempted; not acquired | Not read | 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. |
| Required protocol | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | 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. |
| Required analysis plan | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | 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. |
| Required result tables and safety material | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | 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. |
| Required funding and interests | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

## What the statuses mean

- 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.

## Change history

2026-10-10 · Public page/materials 1.0. A public view and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed.